Contains Nonbinding Recommendations 
Draft  Not for Implementation 
Orthopedic Non-Spinal Bone Plates, 
Screws, and Washers - Premarket 
Notification (510(k)) Submissions  
Draft Guidance for Industry and 
Food and Drug Administration Staff 
DRAFT GUIDANCE 
This draft guidance document is being distributed for comment purposes 
only.  
Document issued on: March 29, 2023 
You should submit comments and suggestions regarding this draft document within 60 days 
of publication in the Federal Register of the notice announcing the availability of the draft 
guidance. Submit electronic comments to http://www.regulations.gov. Submit written 
comments to the Dockets Management Staff, Food and Drug Administration, 5630 Fishers 
Lane, Room 1061, (HFA-305), Rockville, MD 20852-1740. Identify all comments with the 
docket number listed in the notice of availability that publishes in the Federal Register. 
For questions regarding this document, contact OHT6: Office of Orthopedic Devices/DHT6C: 
Division of Restorative, Repair and Trauma Devices at (301) 796-5650. 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Devices and Radiological Health  Contains Nonbinding Recommendations 
 
Draft  Not for Implementation 
 
Preface 
 
Additional Copies 
 
Additional copies are available from the Internet. You may also send an email request to 
CDRH-Guidance@fda.hhs.gov to receive a copy of the guidance. Please include the document 
number GUI00019023 and complete title of the guidance in the request. 
  Contains Nonbinding Recommendations 
 
Draft  Not for Implementation 
 
Table of Contents
 
 
I.  INTRODUCTION ........................................................................................................ 1 
II.  BACKGROUND .......................................................................................................... 2 
III.  SCOPE .......................................................................................................................... 2 
IV.  PREMARKET SUBMISSION RECOMMENDATIONS ........................................... 4 
A.  Indications for Use .................................................................................................. 4 
B.  Device Description.................................................................................................. 5 
C.  Predicate Comparison ........................................................................................... 10 
D.  Labeling ................................................................................................................ 13 
E.  Sterility .................................................................................................................. 14 
F.  Reprocessing (including single-use devices provided non-sterile and intended for 
sterile processing) ....................................................................................................... 14 
G.  Pyrogenicity .......................................................................................................... 16 
H.  Shelf Life and Packaging ...................................................................................... 16 
I.  Biocompatibility ................................................................................................... 17 
J.  Magnetic Resonance (MR) Compatibility for Passive Implants .......................... 19 
K.  Non-Clinical Testing ............................................................................................. 19 
1.  Plate Mechanical Performance ....................................................................... 21 
2.  Screw Mechanical Performance ..................................................................... 22 
3.  Computational Modeling and Engineering Analysis ...................................... 23 
L.  Non-Clinical Animal and/or Clinical Performance Testing ................................. 25 
V.  MODIFICATIONS (DEVICES SUBJECT TO 510(K)) ............................................ 26 
APPENDIX A EXAMPLE TABLE OF PLATE TEST METHODS AND DATA 
SUMMARY ............................................................................................................................ 29 
APPENDIX B EXAMPLE TABLE OF SCREW TEST METHODS AND DATA 
SUMMARY ............................................................................................................................ 31 
 
 
  Contains Nonbinding Recommendations 
 
Draft  Not for Implementation 
 
Orthopedic Non-Spinal Bone Plates, 
1 
Screws, and Washers -  Premarket 
2 
Notification (510(k)) Submissions 
3 
Draft Guidance for Industry and Food 
4 
and Drug Administration Staff 
5 
6   
7  This draft guidance, when finalized, will represent the current thinking of the Food and Drug 
8  Administration (FDA or Agency) on this topic. It does not establish any rights for any person 
9  and is not binding on FDA or the public. You can use an alternative approach if it satisfies the 
10  requirements of the applicable statutes and regulations. To discuss an alternative approach, 
11  contact the FDA staff or Office responsible for this guidance as listed on the title page.  
12   
13  I.  Introduction 
14  This draft guidance document provides recommendations for premarket notification (510(k)) 
15  submissions for non-resorbable bone plate, screw, and washer devices. These devices are 
16  indicated for orthopedic bone fixation and exclude indications for spinal, mandibular, 
17  maxillofacial, cranial, and orbital fracture fixation.  
18   
19  For the current edition of the FDA-recognized consensus standard(s) referenced in this 
20  document, see the FDA Recognized Consensus Standards Database.1  For more information 
21  regarding use of consensus standards in regulatory submissions, please refer to the FDA 
22  guidance titled Appropriate Use of Voluntary Consensus Standards in Premarket Submissions 
23  for Medical Devices.2 
24   
25  In general, FDAs guidance documents do not establish legally enforceable responsibilities. 
26  Instead, guidances describe the Agencys current thinking on a topic and should be viewed only 
27  as recommendations, unless specific regulatory or statutory requirements are cited. The use of 
28  the word should in Agency guidances means that something is suggested or recommended, but 
29  not required. 
30   
31   
 
1 Available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm. 
2 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/appropriate-use-
voluntary-consensus-standards-premarket-submissions-medical-devices. 
 
1  Contains Nonbinding Recommendations 
 
Draft  Not for Implementation 
 
32  II.    Background 
33  Non-spinal, non-resorbable bone plates, screws and washers are implants intended for bone 
34  fixation. These are class II medical devices for which the safety and effectiveness are well-
35  established. This guidance is intended to facilitate consistency in information provided in 
36  submissions by addressing common deficiencies related to device description and performance 
37  testing and by identifying applicable cross-cutting guidances and consensus standards. Certain 
38  orthopedic non-spinal metallic bone screws and washers under product codes HTN and HWC 
39  and non-spinal bone plates under product code HRS (see Section III. Scope below for more 
40  information) may also be appropriate for submission of a 510(k) through the Safety and 
41  Performance Based Pathway.3  For more information, refer to FDAs guidance entitled 
42  Orthopedic Non-Spinal Metallic Bone Screws and Washers - Performance Criteria for Safety 
43  and Performance Based Pathway4 and Orthopedic Fracture Fixation Plates - Performance 
44  Criteria for Safety and Performance Based Pathway.5 
45   
46  This document supplements other FDA documents regarding the specific content requirements 
47  of a premarket notification (510(k)) submission. You should also refer to 21 CFR 807.87, 21 
48  CFR 814.20 and FDAs guidance, Format for Traditional and Abbreviated 510(k)s.6 
49   
50  III.  Scope 
51  The scope of this document is limited to class II, orthopedic, non-resorbable, non-spinal bone 
52  plate and screw systems, stand-alone bone screws, and associated washers. These devices are 
53  regulated under 21 CFR 888.3030 and 21 CFR 888.3040 with the product codes listed in the 
54  table below: 
55   
56  Table 1  Relevant Product Codes 
57   
Product Code  Regulation Number  Name 
HRS  21 CFR 888.3030  Plate, Fixation, Bone 
HWC  21 CFR 888.3040  Screw, Fixation, Bone 
HTN  21 CFR 888.3030  Washer, Bolt Nut 
NDG  21 CFR 888.3030  Washer, Bolt, Nut, Non-Spinal, 
Metallic 
58   
59  Devices that fall within the scope of this guidance document are comprised of non-resorbable 
60  metallic or polymeric components such as, but not limited to, those manufactured from: 
 
3 See https://www.fda.gov/regulatory-information/search-fda-guidance-documents/safety-and-performance-based-
pathway. 
4 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/orthopedic-non-spinal-metallic-bone-
screws-and-washers-performance-criteria-safety-and-performance. 
5 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/orthopedic-fracture-fixation-plates-
performance-criteria-safety-and-performance-based-pathway 
6 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/format-traditional-and-abbreviated-
510ks-guidance-industry-and-fda-staff. 
 
2  Contains Nonbinding Recommendations 
 
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61    titanium alloy (e.g., per ASTM F136 Standard Specification for Wrought Titanium-
62  6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant 
63  Applications (UNS R56401) or ASTM F1295 Standard Specification for Wrought 
64  Titanium-6Aluminum-7Niobium Alloy for Surgical Implant Applications (UNS 
65  R56700)),  
66    commercially pure titanium (e.g., per ASTM F67 Standard Specification for Unalloyed 
67  Titanium, for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, 
68  UNS R50700)), 
69    stainless steel (e.g., per ASTM F138 Standard Specification for Wrought 18Chromium-
70  14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS 
71  S31673)),  
72    cobalt-chrome alloy (e.g., per ASTM F1537 Standard Specification for Wrought 
73  Cobalt-28Chromium-6Molybdenum Alloys for Surgical Implants (UNS R31537, UNS 
74  R31538, and UNS R31539)),  
75    polyetheretherketone (PEEK) (e.g., per ASTM F2026 Standard Specification for 
76  Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications), or  
77    chopped carbon fiber reinforced (CFR) PEEK (e.g., per ASTM F3333 Standard 
78  Specification for Chopped Carbon Fiber Reinforced (CFR) Polyetheretherketone 
79  (PEEK) Polymers for Surgical Implant Applications).  
80   
81  This guidance document does not specifically address non-spinal bone plate, screw, and washer 
82  devices with the following characteristics: 
83    nitinol devices, 
84    coated devices, 
85    devices with surface modifications, 
86    devices incorporating antimicrobial agents,  
87    devices with complex geometries,  
88    devices with differing modularities,  
89    devices with unique geometric features,  
90    devices that utilize unconventional surgical techniques (e.g., those that differ from open 
91  reduction and internal fixation), 
92    resorbable devices,  
93    additively manufactured devices, or  
94    devices possessing other unique technological characteristics.  
95   
96  If any of the above characteristics pertain to your device, we recommend submitting a Pre-
97  Submission to obtain Agency feedback. For further information regarding the Q-Submission 
98  Program, refer to Requests for Feedback and Meetings for Medical Device Submissions: The 
99  Q-Submission Program.7 
100   
101  In addition, this guidance document does not address the following device types: 
 
7 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/requests-feedback-and-meetings-
medical-device-submissions-q-submission-program. 
 
3  Contains Nonbinding Recommendations 
 
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102    Bone plates and screws that are intended for mandibular, maxillofacial, cranial, and 
103  orbital fracture fixation; 
104    Bone plates and screws that are intended for use in the spine and suture anchors; and 
105    Fixation components that are part of a bone anchor tightrope (bone-to-bone or soft 
106  tissue-to-bone), such as those used for reinforcing ankle syndesmosis or correcting 
107  bunion angular deformities.  
108   
109  IV.   Premarket Submission Recommendations 
110  A.  Indications for Use 
111  For each subject device, the intended use(s)/indications(s) should be stated, and a comparison of 
112  the intended use/indications for use to one or more legally marketed predicate device(s) should 
113  be included in your submission. Please note that differences in indications for use (e.g., disease 
114  condition, patient population) may prompt a request for additional information to support the 
115  new indication.8  
116   
117  Examples of uses that have been cleared for these types of 510(k)s include: 
118    long bone fracture fixation9 
119    small bone fracture fixation10 
120    small bone fragment fixation 
121    fracture fixation of specific anatomical locations (e.g., femur, tibia, fibula, clavicle, 
122  humerus, olecranon) 
123    arthrodesis of a joint or osteotomy of the small bones 
124    as components of specific cerclage systems 
125   
126  We recommend that the indication for use statements for these devices, avoid vague language 
127  (e.g., bone fixation, small bones) to help reduce ambiguity and clarify appropriate device 
128  use. Additionally, 510(k) submissions involving any spinal or non-orthopedic uses should be 
129  submitted in a separate 510(k) submission to the appropriate review group or Office of Health 
130  Technology.  
131   
132  If seeking an indication for use in osteopenic bone, comparison should be made to one or more 
133  legally marketed predicate device(s) intended for use in the same anatomical location with 
 
8 Within the 510(k) paradigm, any change in indications for use that raises different questions of safety and 
effectiveness and therefore precludes a meaningful comparison with the predicate device constitutes a new intended 
use and would be deemed not substantially equivalent to the predicate device.  See also FDAs guidance The 
510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)], available at 
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/510k-program-evaluating-substantial-
equivalence-premarket-notifications-510k.  
9 The term "long bone" refers to fracture fixation of the femur, tibia, fibula, humerus, ulna, and radius. 
10 The term "small bone" refers to fracture fixation of the wrist, hand, and foot. 
  
 
 
 
4  Contains Nonbinding Recommendations 
 
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134  similar indications. If seeking indications for osteoporotic bones or poor bone quality"11 (e.g., 
135  lower bone mineral density (BMD) attributable to Type I diabetes mellitus), additional 
136  information may be requested to demonstrate performance of the implant in the simulated use 
137  and bone condition to support the indications for use.   
138   
139  For bone plates or screws with pediatric indications, you should identify the pediatric 
140  subpopulations that the devices are intended to treat. Refer to the guidance document entitled 
141  Premarket Assessment of Pediatric Medical Devices12 for more information. 
142  B.  Device Description 
143  We recommend you identify your device by the applicable regulation number and product code 
144  indicated in Section III above and include the information described below. 
145   
146  For bone plates and screws, we recommend that you provide images of the device and the 
147  following system level overview information in tabular format, for example, as shown in Table 
148  2: 
149   
150  Table 2  General System Descriptive Information 
151   
System Description  Subject Device (Examples) 
Intended use  Fracture fixation; joint 
arthrodesis 
Product code  HRS 
Target population  Adults only; pediatrics; 
adults and pediatrics 
Anatomical site(s) of use  Long bones; proximal 
humerus; 
Tarsometarsophalenageal 
joint 
Provided sterile/non-sterile  Provided non-sterile; 
Provided sterile  
Sterilization method  Steam; gamma irradiation 
Shelf life  N/A; 2 years 
Packaging (if provided sterile)  N/A 
System components that can be  All instruments, cleaning 
reprocessed and, if so, are cleaning  instructions included in the 
Instructions for Use 
 
11 Bone quality refers to those structural and material properties of bone that determine its biomechanical behavior 
in ways that are not accounted for by bone quantity or mass.  For orthopedic devices, FDA defines the term poor 
bone quality as impaired bone strength (biomechanical performance) sufficient to increase fracture risk or hardware 
failure that is not accounted for by measured bone density. 
12 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/premarket-assessment-pediatric-
medical-devices. 
 
 
5  Contains Nonbinding Recommendations 
 
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instructions included and location 
within submission 
Summary of how the device achieves  Bone plates are used in 
its intended function  conjunction with compatible 
bone screws to create a 
stabilized construct that 
promotes fracture healing. 
The system contains locking 
and nonlocking screws. 
Screw holes and screw head 
design allow variable angle 
placement within a 15 degree 
cone.  
152   
153  The submission should include a table with the name of each component in the system with its 
154  associated part number. Descriptive information for each component should include critical 
155  dimensions for the entire range of available sizes in tabular format. Examples of recommended 
156  information to include and example format for critical dimensions for bone plates, bone screws, 
157  and washers/bolt nuts are provided in Tables 3, 4, and 5 below. For submissions that include 
158  multiple designs or device types, a separate table for each design or device type should be 
159  included in the device description section with the information as outlined below. For any FDA-
160  recognized consensus standards referenced in these tables, we recommend you specifically state 
161  the edition of the standard that was used. 
162   
163  For each plate design you should include the information found in Table 3.   
164   
165  Table 3  Plate Descriptive Information 
166   
Plate Description  Subject Device 
(Examples) 
Representative image or photograph of   
component 
Anatomical site of use  Long bone diaphysis; 
long bone epiphysis;  
Materials  Ti-6Al-4V titanium 
alloy; Cobalt-Chrome 
Any standards to which the materials conform  ASTM F136; ASTM 
F1537 
General plate shape  T-plate; straight plate 
Number of holes   X number of holes 
Hole dimensions  Y mm hole diameter 
Locking mechanism, if applicable  Non-locking 
 
6  Contains Nonbinding Recommendations 
 
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Plate Description  Subject Device 
(Examples) 
Screw angle placement ability relative to plate  Orthogonal placement; 
fixed angle placement; 
variable angle 
placement in a 15 
degree polyaxial cone 
for locking screws only 
Plate width range (minimum and maximum in  A  B mm 
the structurally critical region) 
Plate length range  C  D mm 
Plate thickness range (minimum and maximum  E  F mm 
in the structurally critical region) 
Previously cleared compatible screws  2.7mm screws lengths 
10mm  30mm; 510(k) 
number(s) 
New proposed compatible screw sizes  3.0mm diameter 
cortical screws and 
4.5mm cancellous 
screws in lengths 8mm 
 40mm. 
Compatible screw features  Locking, 10 degree 
variable angle locking 
screws 
167   
168  For each screw design you should include the information found in Table 4. 
169   
170  Table 4  Stand-Alone Screw Descriptive Information 
171   
Screw Description  Subject Device 
(Examples) 
Representative image or photograph of   
component 
Materials  316L Stainless Steel; 
CP Ti Grade 4 
Any standards to which the materials conform  ASTM F138; ASTM 
F67 
Type of screw   Cortical; Snap-off 
If cannulated, cannula diameter  A mm diameter 
Screw length range  B  C mm 
Length of threaded region range  D  E mm 
Minor screw diameter range  F  G mm 
Major screw diameter range  H  I mm 
Thread pitch range  J  K mm 
 
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172   
173  For each washer/bolt nut design you should include the information found in Table 5. 
174   
175  Table 5  Washer Descriptive Information 
176   
Washer/Bolt Nut Description  Subject Device 
(Examples) 
Representative image or photograph of   
component 
Materials  316L Stainless Steel 
Any standards to which the materials conform  ASTM F138 
Inner diameter range  A  B mm 
Outer diameter range  C  D mm 
Thickness range  E  F mm 
Previously cleared compatible screws  510(k) number(s) 
New proposed compatible screws  Subject screw  
diameters in mm 
177   
178  You should submit engineering drawings for each size and part number that include critical 
179  dimensions and tolerances. Alternatively, you should supply representative drawings with a table 
180  of each part number that includes critical dimensions, as follows, for each size: 
181   
182    Plates: plate angulation (if applicable), minimum and maximum length, minimum and 
183  maximum width in the structurally critical region, minimum and maximum thickness in 
184  structurally critical region, screw hole diameter, and distance between screw holes. 
185   
186    Screws: minimum and maximum length, threaded diameter, core diameter, axial thread 
187  length, thread pitch, screw head diameter, height, and thread feature if applicable. 
188   
189  For devices incorporating embedded fibers, such as carbon fiber reinforced PEEK (CFR PEEK), 
190  the following material parameters should be included in the device description: percent fiber 
191  used, length of fibers (average and distribution), fiber direction, and sizing agent used (for 
192  interfacial adhesion between fiber and polymer). These parameters may impact the conditions 
193  under which delamination between fiber and matrix occurs, which could impact device 
194  performance. This is further discussed in Section IV.J below.  
195   
196  If the device is provided with surgical instrumentation, the instruments should also be identified 
197  in the submission, along with the associated classification regulation(s). For example, many 
198  instruments that are for general use and can be used in any generic orthopedic bone plate or 
199  screw implantation procedure, are regulated under 21 CFR 878.4800 Manual surgical instrument 
200  for general use or 21 CFR 888.4540 Orthopedic manual surgical instrument. These instruments 
201  are considered class I and are exempt from 510(k) review. Descriptive information, as shown in 
 
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202  Table 6, for class II, device-specific instruments13 should be included in the device description 
203  section of your submission.  
204   
205  Table 6  Device-Specific Instrument Descriptive Information 
206   
Instrumentation Description  Subject Instrument 
(Examples) 
Name of the instrument and part number  Snap-off screwdriver; 
Volar plate head drill 
guide block 
510(k) number if instrument has been previously  New instrument 
cleared 
Representative engineering drawing(s),  See section X, page Y 
schematic, illustration, photograph and/or figure  for engineering 
drawing 
Purpose and brief description of the instrument  Intended to interact 
specifically with the 
handle of the screw to 
allow removal upon 
clockwise twisting of 
the driver after the 
screw is fully seated; 
Intended to guide 
screw placement 
directly into unique 
screw hole pattern on 
the head of the plate 
Statement clarifying if the instrument is single- Reusable; single-use 
use or reusable 
Provided sterile/non-sterile  Non-sterile; sterile 
Sterilization method  Steam; Ethylene 
oxide 
Materials  PEEK, Stainless steel 
Any standards or material specifications to  Master file number; 
which the materials conform  ASTM F899 
Duration of contact with the patient  Transient contacting 
during screw 
insertion; limited 
contact for the entire 
duration of surgery 
 
13 A device-specific orthopedic instrument is considered to be an accessory designed specifically for appropriate 
implantation or placement of the parent device, based upon unique dimensions, geometry, and/or deployment. See 
84 FR 14865. 
 
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Instrumentation Description  Subject Instrument 
(Examples) 
Color additives, if included in patient contacting  Blue color additive X 
components  in the handle; red 
color additive Z in the 
implant 
207  C.  Predicate Comparison  
208  For devices reviewed under the 510(k) process, manufacturers should compare their new device 
209  to a similar legally marketed predicate device to support its substantial equivalence ((section 
210  513(i) of the Federal Food, Drug, and Cosmetic Act (FD&C Act); 21 CFR 807.87(f))))) unless 
211  utilizing the optional approach identified in the FDA guidance Safety and Performance Based 
212  Pathway.14 (See Orthopedic Non-Spinal Metallic Bone Screws and Washers - Performance 
213  Criteria for Safety and Performance Based Pathway15 and Orthopedic Fracture Fixation Plates 
214  - Performance Criteria for Safety and Performance Based Pathway16). This comparison should 
215  provide information to show how your device is similar to and different from the predicate. Side 
216  by side comparisons, whenever possible, are desirable. See Tables 7, 8, 9, and 10 below for 
217  examples of how this information can be organized. These tables are not intended to represent an 
218  exhaustive list of comparative parameters; ensure you provide all relevant device descriptive 
219  characteristics as outlined in Section IV.B, above. The predicate device comparison section of 
220  your submission should also include a discussion of why any differences in technological 
221  characteristics identified in the table(s) below do not raise different safety and effectiveness 
222  questions, and how the subject device is substantially equivalent to the predicate(s). 
223   
224  Table 7  Predicate Comparison General Descriptive Information 
225   
Primary  Additional 
System Characteristics  Subject Device 
Predicate  Predicate 
Intended use  Arthrodesis and  Arthrodesis   Fracture 
fracture fixation  fixation 
Classification/Product code       
Target population  Adults     
Anatomical site of use  Foot  Mid foot  Forefoot 
Provided sterile/non-sterile       
Sterilization method       
Shelf life       
Packaging        
226   
 
14 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/safety-and-performance-based-
pathway. 
15 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/orthopedic-non-spinal-metallic-
bone-screws-and-washers-performance-criteria-safety-and-performance. 
16 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/orthopedic-fracture-fixation-plates-
performance-criteria-safety-and-performance-based-pathway. 
 
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227  Table 8  Predicate Comparison Plate Descriptive Information 
228   
Primary  Additional 
Plate Description  Subject Device 
Predicate  Predicate 
Representative image or       
photograph of component 
Anatomical site of use  Proximal humerus  Humerus  Long bones 
Materials  CP Ti Grade 4  Stainless steel   
Any standards to which the  ASTM F67  ASTM F138   
materials conform 
General plate shapes  Anatomic specific  Straight plate   
Number of holes   12  8   
Hole dimensions  5.2mm diameter  6mm diameter   
holes  holes 
Locking mechanism if  Locking screws mate  Non-locking  Locking caps 
applicable  directly with threads 
on the plate 
Screw placement trajectory  Fixed angle locking  orthogonal  Fixed angle 
screws; non-locking  non-locking 
screws inserted in a 
10 degree polyaxial 
cone 
Plate width range  8mm  30mm  8mm  12mm   
Plate length range  50mm  150mm  80mm   
Plate thickness range  3mm  3.5mm  2.5mm   
Compatible screw sizes  3.5mm  4.0mm  3.5mm 
Compatible screw types  Locking, non- Variable angle   
locking  locking screw 
229   
230  Table 9  Predicate Comparison Stand-Alone Screw Descriptive Information 
231   
Primary  Additional 
Screw Description  Subject Device 
Predicate  Predicate 
Representative image or       
photograph of component 
Materials  Stainless steel  Ti-6Al-4V   
titanium alloy; 
Cobalt-Chrome 
Any standards to which the  ASTM F138  ASTM F136;   
materials conform  ASTM F1537 
Type of screw   Headless screw  Cancellous  Snap-off screw 
screw 
If cannulated: cannula diameter  1.5mm     
Screw length range  8mm  60mm     
 
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Primary  Additional 
Screw Description  Subject Device 
Predicate  Predicate 
Length of threaded region range  5mm  50mm     
Minor screw diameter range  2.5mm     
Major screw diameter range  3.5mm  3.2mm   
Thread pitch range  1.0mm  1.25mm   
232   
233  Table 10  Predicate Comparison Washer Descriptive Information 
234   
Primary  Additional 
Washer/Bolt Nut Description  Subject Device 
Predicate  Predicate 
Representative image or photograph of       
component 
Materials  CP Ti Grade 4  Stainless steel   
Any standards to which the materials  ASTM F67  ASTM F138   
conform 
Inner diameter range  3mm  6mm     
Outer diameter range  5mm  10mm     
Thickness  0.5mm     
Compatible screws  2.7mm  7.5mm     
235   
236    The materials used for bone plates and bone screws impact the mechanical performance 
237  of these devices. If your plate and/or screw components are manufactured from different 
238  materials than the predicates you have identified, or use different manufacturing methods 
239  or processing steps, additional material characterization may be requested, such as fatigue 
240  performance of the plate, or mechanical evaluations of the plate/screw interface. We 
241  recommend you submit a Pre-Submission to discuss the testing plans with FDA. For 
242  more information about Pre-Submissions and the Q-Submission program, refer to the 
243  FDA guidance document entitled Requests for Feedback on and Meetings for Medical 
244  Device Submissions:  The Q-Submission Program.17 
245   
246    Metallic fracture fixation hardware components that are generally in contact with 
247  components made of dissimilar metals may result in galvanic corrosion. Additionally, 
248  novel materials may raise questions regarding corrosion in that corrosion may cause 
249  premature failure of the device and adverse biological reactions. If your plate or screw 
250  system contains metallic components that are different from the predicate device, or if the 
251  combination of metals in the subject system is different or has known susceptibility to 
252  corrosion (e.g., connections of nitinol and stainless steel components), additional 
253  information may be necessary to demonstrate that corrosion susceptibility over the entire 
254  surface of the final finished device and interfacing components is equal to or less than 
255  that measured in a legally marketed device with the same intended use. ASTM F2129 
256  Standard Test Method for Conducting Cyclic Potentiodynamic Polarization 
 
17 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/requests-feedback-and-meetings-
medical-device-submissions-q-submission-program. 
 
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257  Measurements to Determine the Corrosion Susceptibility of Small Implant Devices may 
258  be appropriate to analyze corrosion susceptibility of your device. We recommend you 
259  submit a Pre-Submission to discuss the testing plans with FDA. For more information 
260  about Pre-Submissions and the Q-Submission program, refer to the guidance Requests 
261  for Feedback and Meetings for Medical Device Submissions:  The Q-Submission 
262  Program.18 
263  D.  Labeling 
264  The premarket notification must include proposed labeling in sufficient detail to satisfy the 
265  requirements of 21 CFR 807.87(e). Proposed labels and labeling, sufficient to describe the bone 
266  plates, screws, and washers, their intended use, and the directions for use should be provided. 
267   
268  As prescription devices, bone plates, screws, and washers are exempt from having adequate 
269  directions for use under section 502(f)(1) of the Federal Food, Drug and Cosmetic Act (FD&C 
270  Act)) as long as the conditions in 21 CFR 801.109 are met. For instance, labeling should include 
271  adequate information for practitioner use of the device, including indications, effects, routes, 
272  methods, frequency and duration of administration and any relevant hazards, contraindications, 
273  side effects and precautions. (21 CFR 801.109(d)).  
274   
275  In addition to requirements in 21 CFR part 801, labeling should include the following 
276  information: 
277   
278    Device description (including material and sterility status); 
279    Device use (including single-use/reusable, intended users or specific patient populations); 
280    Contraindications (e.g., active infection, inability to comply with post-operative weight 
281  bearing instructions, inadequate bone stock or poor blood supply) 
282    Warnings (e.g., not to use the device across an active growth plate for devices indicated 
283  for pediatric use); 
284    MR safety information (refer to Section J); 
285    Cleaning and sterilization instructions, if applicable (refer to Sections E and F); and 
286    Removal instructions (particularly for devices indicated for pediatric use). 
287   
288  Additionally, since plating systems can contain many different plate types and components for 
289  creating a fracture fixation construct, we recommend that you provide information in the labeling 
290  to aid the surgeon in proper construct selection (e.g., material labeling for plates of the identical 
291  geometry or comparative performance information).  
292   
293  For plate(s) made of anisotropic materials, if the submission includes labeling that instructs users 
294  to contour plates to fit varying patient anatomies, we recommend also including in the 510(k) 
 
18 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/requests-feedback-and-meetings-
medical-device-submissions-q-submission-program. 
 
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295  submission testing and/or justification demonstrating that the plate(s) maintains adequate 
296  strength following such bending. This is further discussed in Section IV.K.1 below. 
297  E.  Sterility  
298  Significance: Bone plates, screws, washers, and patient contacting instrumentation should be 
299  adequately sterilized to minimize infections and related complications. 
300   
301  Recommendation:  For bone plates, screws, and washers, and instruments labeled as sterile, we 
302  recommend that you provide information for the finished device in accordance with FDAs 
303  guidance Submission and Review of Sterility Information in Premarket Notification (510(k)) 
304  Submissions for Devices Labeled as Sterile.19 
305  F.  Reprocessing (including single-use devices provided non-
306  sterile and intended for sterile processing) 
307  Significance: Many of the patient contacting instruments associated with bone plates, screws, 
308  and washers are reused, and should be adequately cleaned and sterilized between uses to 
309  minimize infections and prevent device degradation. Bone plates, screws, and washers can also 
310  be single-use medical devices initially supplied as non-sterile to the user and necessitate the user 
311  to process (clean and sterilize) the device prior to its use. 
312   
313  Cleaning instructions in the labeling should clearly identify their applicability for reprocessing 
314  soiled reusable instruments or their applicability to new and uncontaminated implants and 
315  instruments prior to sterilization. 
316   
317  Recommendation: Instructions on how to reprocess a reusable device or process a single-use 
318  device that is provided non-sterile to the user are critical to ensure that a device is appropriately 
319  prepared for its initial and/or subsequent uses and should be included in the labeling.  
320   
321  Instructions for cleaning should be designed and validated for the type of contamination 
322  anticipated on the device, based on its intended use.  Accordingly, there may be separate, 
323  dedicated cleaning instructions; for new, uncontaminated single-use devices prior to sterilization, 
324  as well as separate, dedicated instructions for routine cleaning of contaminated reusable medical 
325  instruments prior to sterilization. Single-use devices such as implants, should be cleaned 
326  separately from soiled reusable devices to prevent cross contamination.     
327   
328  The removal of all residues of manufacturing materials such as lubricants, oils, particulates, and 
329  other debris should occur during the manufacturing process, as part of Good Manufacturing 
330  Practices (see 21 CFR Part 820). Additionally, health care facilities are unlikely to have the 
331  capacity, materials, or adequately trained personnel to remove residues of manufacturing 
332  materials from medical devices. Validated cleaning steps should be performed for removing 
333  manufacturing contaminants from your implants at the site of manufacture, in accordance with 
334  the Quality System Regulation, 21 CFR 820.70(h).    
 
19 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/submission-and-review-sterility-
information-premarket-notification-510k-submissions-devices-labeled. 
 
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335  For recommendations regarding the development and validation of reprocessing parameters and 
336  the reprocessing instructions in your proposed device labeling, refer to FDAs guidance 
337  Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling.20 
338   
339  The following list includes some additional considerations for reprocessing instructions that are 
340  included in the labeling for bone plates, screws, and washers provided non-sterile to the end user: 
341   
342    Final rinse water quality should include specifications qualified for the devices 
o
343  intended use. For example, Critical Water, as currently defined by AAMI TIR34: 
344  Water for the Reprocessing of Medical Devices, is recommended to address various 
345  concerns for implantable devices.   
346    We recommend that the labeling include a statement to warn against use of devices 
o
347  that may have become damaged or contaminated. For example: If the device has 
348  become damaged or contaminated, it should NOT be reprocessed and should be 
349  properly disposed of.  
350  If the labeling instructs the end user to reprocess (sterilize, or clean and sterilize) 
351  opened-but-unused devices, validated instructions (for sterilization, or cleaning and 
352  sterilization) should be included in the labeling. In these circumstances, we 
353  recommend that labeling designated for Opened-but-Unused products include 
354  comprehensive instructions that: 
355  1.  explicitly define contaminated and characterize the conditions under which 
356  a device would be considered unused.   
357  Note: FDA considers that:  
358    a statement such as "no contamination with body fluids" is not adequate, 
359  as not all contamination is necessarily visible; 
360    a device which has been introduced to the sterile field, even if unused, 
361  may be contaminated as such items may have been subjected to 
362  aerosolized contaminants or other sources of contamination; and 
363     all handling should be considered a potential source of contamination.   
364  2.  provide validated reprocessing instructions for Opened-but-Unused product 
365  that are consistent with definitions as recommended above.   
366   
367    We recommend that reprocessing validation activities for bone plates, screws, and 
o
368  washers account for the use of sterilization trays, and instructions in the labeling 
369  should be consistent with these validation activities (e.g., if trays were not stacked 
 
20 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/reprocessing-medical-devices-
health-care-settings-validation-methods-and-labeling. 
 
 
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370  during the validation activities, then a Do Not Stack Trays warning should be 
371  included).  
372  We recommend that information about the sterilization trays be included in the 
373  submission for bone plates, screws, and washers. If a third party, general use 
374  sterilization tray is utilized, the 510(k) number should be provided. For dedicated 
375  sterilization trays that are unique to a particular orthopedic system, adequate device 
376  description information should be provided, including an explanation of the tray 
377  dimensions, material, and load configuration and contents. If you intend to leverage 
378  information from a previously validated worst-case system, you should also include 
379  an explanation of how the challenge device is applicable to the subject system, in 
380  accordance with FDA-recognized consensus standard, ANSI/AAMI/ISO 17665-1: 
381  Sterilization of health care products  Moist heat  Part 1. 
382  G.  Pyrogenicity 
383  Significance:  Pyrogenicity testing is used to help protect patients from the risk of febrile 
384  reaction due to gram-negative bacterial endotoxins and/or chemicals that can leach from a 
385  medical device (e.g., material-mediated pyrogens). 
386   
387  Recommendation:  To address the risks associated with the presence of bacterial endotoxins, 
388  bone plates, screws, and washers provided sterile should meet pyrogen limit specifications by 
389  following the recommendations outlined in FDAs guidance  Submission and Review of 
390  Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as 
391  Sterile.21  You should also follow the recommendations in Guidance for Industry Pyrogen and 
392  Endotoxins Testing: Questions and Answers.22  To address the risks associated with material-
393  mediated endotoxins, follow the recommendations in FDAs guidance Use of International 
394  Standard ISO-10993-1, 'Biological Evaluation of Medical Devices Part 1: Evaluation and 
395  Testing.23  
396   
397  For devices intended to be labeled as non-pyrogenic, we recommend that both bacterial 
398  endotoxins and material-mediated pyrogens be addressed. 
399  H.  Shelf Life and Packaging  
400  Significance:  Package shelf life (stability) and package integrity (performance) testing is 
401  conducted to support the proposed package shelf life (expiration date) and performance. Testing 
402  should also be conducted to evaluate any changes to device performance or functionality. 
403   
404  Recommendation: For devices provided sterile, you should provide a description of the 
405  packaging, including how it will maintain the devices sterility, a description of the package 
 
21 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/submission-and-review-sterility-
information-premarket-notification-510k-submissions-devices-labeled. 
22 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/pyrogen-and-endotoxins-testing-
questions-and-answers. 
23 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/use-international-standard-iso-
10993-1-biological-evaluation-medical-devices-part-1-evaluation-and. 
 
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406  integrity test methods, but not the package integrity test data. We recommend that package 
407  integrity test methods include simulated distribution and associated package integrity testing, as 
408  well as simulated (and/or real time) aging and associated seal strength testing, to validate 
409  package integrity and shelf life claims. We recommend you follow the methods described in ISO 
410  11607-1 Packaging for terminally sterilized medical devices  Part 1: Requirements for 
411  materials, sterile barrier systems and packaging systems  and ISO 11607-2 Packaging for 
412  terminally sterilized medical devices  Part 2: Validation requirements for forming, sealing and 
413  assembly processes. 
414   
415  With respect to evaluating the effects of aging on device performance or functionality, shelf life 
416  studies should evaluate the critical physical and mechanical properties of the device to ensure it 
417  will perform adequately and consistently during the entire proposed shelf life. To evaluate device 
418  functionality, we recommend that you assess each of the bench tests described in Section K and 
419  repeat all tests that evaluate design components or characteristics that are potentially affected by 
420  aging. 
421   
422  We recommend that you provide a summary of the test methods used for your shelf life testing, 
423  results, and the conclusions drawn from your results. If you use devices subject to accelerated 
424  aging for shelf life testing, we recommend that you specify the way in which the devices were 
425  aged and provide a rationale to explain how the results of shelf life testing, based on accelerated 
426  aging, are representative of the results if the device were aged in real time. We recommend that 
427  you age your devices as per ASTM F1980 Standard Guide for Accelerated Aging of Sterile 
428  Barrier Systems for Medical Devices and specify the environmental parameters established to 
429  attain the expiration date. For devices or components containing polymeric materials or coatings, 
430  you should conduct testing on real-time aged samples to confirm the results of the accelerated 
431  aging study. This testing should be conducted in parallel with 510(k) review and clearance, with 
432  results documented to file in the design history file (i.e., the complete test reports do not need to 
433  be submitted to FDA). 
434  I.  Biocompatibility 
435  Significance:  Bone plates, screws, washers, and accompanying surgical instrumentation contain 
436  patient-contacting materials, which, when used for their intended purpose, (i.e., contact type and 
437  duration), may induce a harmful biological response.  
438   
439  Recommendation:  You should determine the biocompatibility of all patient-contacting materials 
440  present in your device (this includes implants and device-specific instrumentation). If your 
441  device(s) in its final finished form is identical in chemical composition, manufacturing, and 
442  processing methods, and any differences in geometry or surface properties are not expected to 
443  adversely impact the biological response compared to a legally marketed bone plate(s), screw(s), 
444  washer(s), or instrument(s) with a history of successful use, you may reference previous testing 
445  experience, or the literature, if appropriate. For metallic devices it may be appropriate to 
446  reference a recognized consensus standard, while for polymeric devices, a Letter of 
447  Authorization (LOA) for a device Master File (MAF) could be provided. You should refer to the 
448  following FDA webpage for additional information on using device MAFs: 
449  https://www.fda.gov/medical-devices/premarket-approval-pma/master-files. In addition to the 
 
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450  device material information, you should provide information to demonstrate that the subject 
451  device is identical to a legally marketed device with respect to manufacturing material 
452  formulations, processes, packaging, and sterilization methods (if applicable) in its final finished 
453  form. Attachment F of the FDA guidance document, Use of International Standard ISO 10993-
454  1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk 
455  management process,24 includes example documentation language that may be utilized. 
456   
457  If you are unable to identify a legally marketed predicate device with the same nature of contact 
458  and contact duration that uses the same materials and manufacturing process as used in your 
459  device, we recommend that you conduct and provide a biocompatibility evaluation as 
460  recommended in FDAs guidance Use of International Standard ISO-10993-1, Biological 
461  evaluation of medical devices - Part 1: Evaluation and testing within a risk management 
462  process.25   The evaluation should explain the relationship between the identified 
463  biocompatibility risks, the information available to mitigate the identified risks, and any 
464  knowledge gaps that remain. You should then identify any biocompatibility testing or other 
465  evaluations that were conducted to mitigate any remaining risks. We recommend that you 
466  consider the recommendations in this guidance, which identifies the types of biocompatibility 
467  assessments that should be considered and recommendations regarding how to conduct related 
468  tests. 
469   
470  Per ISO 10993-1 Biological evaluation of medical devices  Part 1: Evaluation and testing 
471  within a risk management process and Attachment A of FDAs guidance on ISO-10993-1, bone 
472  plates, screws, and washers are implant devices in contact with tissue/bone for a permanent 
473  contact duration. Therefore, the following endpoints should be addressed in your 
474  biocompatibility evaluation: 
475   
476    cytotoxicity; 
477    sensitization; 
478    irritation or intracutaneous reactivity; 
479    acute systemic toxicity; 
480    material mediated pyrogenicity; 
481    subacute/subchronic toxicity; 
482    genotoxicity; 
483    implantation; 
484    chronic toxicity; and 
485    carcinogenicity. 
486   
487  For device-specific, patient-contacting device instrumentation in contact with tissue/bone for a 
488  limited contact duration, the following endpoints should be addressed in your biocompatibility 
489  evaluation: 
490   
 
24 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/use-international-standard-iso-
10993-1-biological-evaluation-medical-devices-part-1-evaluation-and. 
25 Ibid.  
 
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491    cytotoxicity; 
492    sensitization; 
493    irritation or intracutaneous reactivity; 
494    acute systemic toxicity; and 
495    material mediated pyrogenicity. 
496  J.  Magnetic Resonance (MR) Compatibility for Passive 
497  Implants 
498  Significance:  MR imaging of patients with bone plates, screws, and washers poses the following 
499  potential hazards: 
500    movement of the implant, resulting in tissue damage or displacement of the device; 
501    heating of the tissue surrounding the implant and subsequent tissue damage; and/or 
502    image artifacts that may render the MR images uninterpretable or misleading. 
503   
504  Recommendation:  We recommend that you address the issues affecting safety and compatibility 
505  of your device in the MR environment as described in the FDA guidance Testing and Labeling 
506  Medical Devices for Safety in the Magnetic Resonance (MR) Environment.26 
507   
508  For devices anticipated for use in the MR environment that have not been evaluated for safety in 
509  the MR environment, we recommend you follow FDAs recommendations in section VIII.D. of 
510  the above referenced guidance document.  
511   
512  If you would like to market bone plates, screws, or washers of various sizes and shapes as MR 
513  Conditional, then we recommend you follow our recommendations in the FDA guidance, 
514  Assessment of Radiofrequency-Induced Heating in the Magnetic Resonance (MR) Environment 
515  for Multi-Configuration Passive Medical Devices.27 
516  K.  Non-Clinical Testing 
517  The 510(k) submission should include information to demonstrate that the subject device 
518  provides substantially equivalent fixation of a fracture site. We recommend that you conduct the 
519  testing recommended below to evaluate the material and performance characteristics of your 
520  worst-case device in its final finished form. If your plate, screw, or washer system is indicated 
521  for use in multiple anatomical locations or if the system encompasses a large variety of device 
522  designs, there may be more than one worst-case device that should be supported with mechanical 
523  performance data. 
524   
525  A sample size of five (5) units has historically been accepted as the minimum for bench testing. 
526  Additional issues in testing (e.g., large inter-sample variability) or device design may warrant a 
527  larger sample size.  
 
26 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/testing-and-labeling-medical-
devices-safety-magnetic-resonance-mr-environment. 
27
 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/assessment-radiofrequency-induced-
heating-magnetic-resonance-mr-environment-multi-configuration. 
 
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528   
529  For information on the recommended content and format of test reports for the testing described 
530  in this section, refer to FDAs guidance, Recommended Content and Format of Non-Clinical 
531  Bench Performance Testing Information in Premarket Submissions.28 
532   
533  For the FDA-recognized consensus standards identified below, supplemental documentation to 
534  support a Declaration of Conformity is likely necessary as discussed in FDAs guidance, 
535  Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical 
536  Devices,29 as these standards contain variable methods and do not include acceptance criteria 
537  for all testing recommended in this guidance. The supplemental documentation should include 
538  the items specified in the report section of each testing annex in the consensus standard (and 
539  listed below in Appendices A and B) used to support the premarket submission. Acceptance 
540  criteria, if not included in the applicable FDA-recognized consensus standard(s), should be 
541  provided with a supporting rationale to justify how the performance testing results support a 
542  determination of substantial equivalence. We recommend that you can provide a comparison of 
543  the subject device test results to the test results of a legally marketed predicate device with the 
544  same intended use, in a tabular format such as the examples in Appendices A and B.   
545   
546  The following sections describe the recommended mechanical performance testing endpoints for 
547  bone plates and screws. When a plating systems overall construct and plate designs are similar 
548  to the identified predicate, individual analysis of the worst-case plate and screw components as 
549  listed below may be sufficient to establish substantial equivalence of the construct. When the 
550  overall subject construct differs in fixation method or raises concerns about strength or stability 
551  at the fracture site, additional construct evaluations such as bench testing or in vivo data may be 
552  needed to demonstrate substantial equivalence. Additional endpoints or testing information may 
553  be needed depending on the device design and comparison to the predicate device(s).  Devices 
554  which are made from polymers, metals, or metallic alloys with different properties compared to 
555  the identified predicates, especially resorbable materials, may warrant additional performance 
556  information such as component interface analysis (e.g., wear, corrosion) or fatigue strength 
557  analysis. Technological characteristics that appear to create worse mechanical performance 
558  compared to the identified predicates may warrant additional information to demonstrate 
559  equivalent fracture fixation in construct strength, construct stiffness and fatigue performance.  
560   
561  Submissions for devices made of anisotropic materials should address shear strength of the 
562  devices and risk for crack propagation through additional testing and/or scientific justification. 
563  When evaluating a device(s) containing fibers, such as CFR PEEK, device parameters including 
564  percent fiber used, length of fibers (average and distribution), fiber direction, and sizing agent 
565  (for interfacial adhesion between fiber and polymer) should be taken into consideration as these 
566  parameters can impact the mechanical performance of the device. Specific recommendations for 
567  plate(s) made of anisotropic materials are discussed in Section VI.K.1 below.  
 
28 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/recommended-content-and-format-
non-clinical-bench-performance-testing-information-premarket. 
29 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/appropriate-use-voluntary-
consensus-standards-premarket-submissions-medical-devices. 
 
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568  1.  Plate Mechanical Performance 
569  Significance:  Loss of fracture reduction or construct stiffness can cause 
570  incomplete or absent osteosynthesis leading to device failure and revision surgery.  
571  Mechanical performance testing of plates provides assurance of the devices 
572  ability to perform as intended.  
573     
574  Recommendation: Single cycle bend testing should be conducted on the worst-
575  case subject plate in the worst-case load bearing region. When assessing the 
576  mechanical performance of plates with a worst-case structurally critical region 
577  (that can physically fit between the loading rollers of a four-point bend test), we 
578  recommend performing testing per ASTM F382 Standard Specification and Test 
579  Method for Metallic Bone Plates. The worst-case design selection should consider 
580  plate thickness, second moment of area, length, and overall shape. Depending on 
581  the particular plate geometry and dimensions, modifications to the test setup 
582  outlined in ASTM F382, with appropriate justification, could be considered. 
583  Outcomes for the single cycle (quasi-static) bend testing should include the 
584  bending structural stiffness and the bending strength.  
585   
586  To ensure the test results can be adequately evaluated, we recommend you 
587  provide testing information per ASTM F382 for subject and predicate tests in 
588  tabular format, identifying any differences in test methods and providing a 
589  justification for why these differences do not impact the comparability of results.  
590  See Appendix A, Example Table of Plate Test Methods and Data Summary, for 
591  an example of how test summary information could be organized.   
592   
593  Plates with similar design features and materials to predicate devices typically do 
594  not warrant fatigue bend testing per ASTM F382. However, devices with 
595  differences in technological features compared to traditional plating systems (e.g., 
596  different material selection, complex designs, plate modularities) may warrant 
597  fatigue testing to demonstrate substantial equivalence. Plates with their worst-case 
598  structurally critical region present in the uniform portion of the plate shaft are 
599  expected to show similar trends when comparing static performance and fatigue 
600  performance (if applicable). 
601   
602  If you use an alternative method to ASTM F382, the following should be taken 
603  into account when designing the test setup to determine component or construct 
604  equivalence: the worst-case clinically relevant loading, clinically relevant loading 
605  modes (e.g., axial compression, bending, torsion), differences in material 
606  properties, and differences in dimensions and geometry of the subject and 
607  predicate devices. 
608   
609  For a plate(s) made of anisotropic materials, if bending/contouring is not 
610  explicitly discouraged in the labeling, the submission should include additional 
611  testing and/or a scientific justification to confirm the plate(s) is able to maintain 
612  mechanical performance following worst-case contouring consistent with the 
 
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613  instructions provided in the labeling and common clinical practice.  
614   
615  2.  Screw Mechanical Performance 
616  Significance:  Inadequate mechanical performance can cause screws to fracture 
617  during insertion or during healing. Torsional strength analysis provides assurance 
618  of strength. Loss of fixation can lead to premature failure of the screws or backout 
619  causing pain from increased prominence. Pullout strength analysis provides 
620  assurance of fixation strength. 
621     
622  Recommendation: When assessing the mechanical performance of screws, we 
623  recommend performing 1) insertion/removal torque testing, 2) torsional strength 
624  testing, and 3) pullout strength testing per ASTM F543 Standard Specification 
625  and Test Methods for Metallic Medical Bone Screws. For screws with 
626  technological characteristics (e.g., screw thread designs) that conform to FDA-
627  recognized consensus standards (e.g., ASTM F543), an engineering analysis using 
628  the thread geometry, based upon the equation described by Chapman, et al,30 can 
629  also be utilized to demonstrate equivalence for pullout strength in lieu of testing.  
630   
631  Insertion/removal torque testing, torsional strength testing, and pullout strength 
632  testing should each be conducted on the corresponding worst-case screws. The 
633  worst-case design selection should consider critical parameters such as 
634  major/minor screw diameters, thread pitch and trailing angles, polar moment of 
635  inertia, thread length, flute design. Reported results for torsional strength testing 
636  should include the torsional yield strength and maximum load. Reported results 
637  for insertion/removal torque testing should include, respectively, the maximum 
638  recorded insertion and removal torques. Reported results for pullout testing 
639  should include the maximum load recorded during screw pullout. If pullout 
640  testing is not physically performed, then insertion and removal torque testing can 
641  be leveraged to confirm that the threads are adequately designed and attached to 
642  the screw core diameter. 
643   
644  To ensure the test results can be adequately evaluated, we recommend you 
645  provide reportable information per ASTM F543 for subject and predicate tests in 
646  tabular format, identifying any differences in test methods and providing a 
647  justification for why these differences do not impact the comparability of results.  
648  See Appendix B of this guidance, Example Table of Screw Test Methods and 
649  Data Summary, for an example of how test summary information can be 
650  organized.  
651   
652  Screws with traditional characteristics (e.g., fully threaded) and materials (e.g., 
653  stainless steel, titanium alloy) as described in the consensus standards referenced 
654  in this guidance typically do not warrant additional evaluation beyond the test 
 
30 Chapman, J. R., et al, Factors Affecting the Pullout Strength of Cancellous Bone Screws. J Biomech Eng 1996: 
118(3), 391-8. doi:10.1115/1.2796022.) 
 
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655  methods described in ASTM F543. However, screws with differences in 
656  technological characteristics compared to traditional screws (e.g., different 
657  material selection, complex designs, modularities) may warrant additional static 
658  and fatigue testing to demonstrate substantial equivalence. We recommend you 
659  refer to ASTM F1264 Standard Specification and Test Methods for 
660  Intramedullary Fixation Devices for information on fatigue three- or four-point 
661  bending evaluation methods for screws.  
662   
663  If you use an alternative method to ASTM F543, the following should be taken 
664  into account when designing the test setup: worst-case clinically relevant loading 
665  conditions, differences in material properties, and differences in dimensions and 
666  geometry of the subject and predicate devices.  
667   
668  3.  Computational Modeling and Engineering Analysis 
669  Significance:  Computational modeling (e.g., finite element analysis) and 
670  engineering analysis (e.g., dimensional comparison and theoretical calculation of 
671  mechanical performance based on empirical models) can be used as an alternative 
672  to demonstrate that the mechanical behavior of the worst-case subject plates and 
673  screws are expected to be equal to or better than the predicate devices.  
674     
675  Recommendation: If computational modeling or engineering analysis is used to 
676  address some or all of the endpoints identified in Sections K. 1. and K. 2., 
677  modeling should be performed on the worst-case plate(s) and screw(s). Specific 
678  subject plate geometries, such as changes in geometries over the plate length, 
679  curvatures, and differences in material, can make static and fatigue comparisons 
680  difficult to account for in engineering analysis alone. Therefore, we recommend 
681  validation testing to confirm the accuracy of your computational modeling, 
682  especially for unique design features/components interfaces.  
683   
684  If no physical testing of specimens is conducted, your computational modeling 
685  and/or engineering analysis should address all endpoints identified in Sections K. 
686  1. and K. 2.  Refer to FDAs guidance Reporting of Computational Modeling 
687  Studies in Medical Device Submissions31 for additional details regarding model 
688  validation and reporting numerical simulations. Specifically, refer to Subject 
689  Matter Appendix II of the referenced guidance for details concerning 
690  computational solid mechanics. 
691   
692  An engineering analysis can be used in lieu of bench testing to support substantial 
693  equivalence of the yield strength and structural bending stiffness of a plate if the 
694  predicate plate dimensions and material properties (modulus and yield strength) 
695  are known, and if the predicate plate is manufactured utilizing the same device 
696  material and manufacturing materials and processes as the subject device.  The 
 
31 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/reporting-computational-modeling-
studies-medical-device-submissions. 
 
23  Contains Nonbinding Recommendations 
 
Draft  Not for Implementation 
 
697  second moment of area and material properties at multiple cross-sections for both 
698  the subject and predicate plates can be used to calculate the worst-case theoretical 
699  structural bending stiffness and yield moment of each plate.  
700   
701  Similarly, for screws, an engineering analysis can be used in lieu of bench testing 
702  to support substantial equivalence of a screws torsional performance if the 
703  predicate screw dimensions (e.g., core diameter, cannulation diameter) and 
704  material properties (modulus and yield strength) are known and if the predicate 
705  screw is manufactured utilizing the same material and manufacturing processes as 
706  the subject device.  
707   
708  As referenced above in Section K.2, an engineering analysis based upon the 
709  equation described by Chapman, et al, can be used in lieu of testing to evaluate 
710  pullout strength of the screw if the predicate screw dimensions are known, and if 
711  the material ultimate shear stress (S) and failure modes of the bone foam substrate 
712  are equivalent between the subject and predicate devices. For example, a material 
713  ultimate shear stress value of 3.395 MPa can be used to represent 20 pcf bone 
714  foam in your analysis.  Note that for this analysis to be appropriate, the 
715  instrumentation identified in the associated surgical technique manual should 
716  allow for close to idealized thread engagement. If this assumption is not accurate 
717  for your scenario, then the identified engineering analysis may not be appropriate 
718  for the assessment of the subject device.  
719   
720  For all screws, extract the relevant dimensions below (i.e., screw major diameter, 
721  screw minor diameter, screw pitch, and axial thread length). These dimensions 
722  will be used to quantify thread engagement and calculate the theoretical pullout 
723  strengths for the smallest axial thread lengthened screws in the device system 
724  using the following equation:  
725   
726   
727   
728  Fs = predicted sFFheFFa=r fSSailuAAre =fo r{cSSe (NLL) DDDDDDDDDDDDTTSSFF}
729  S = material ultimate shear stress (MPa) 
730  A = thread shear area (mm2) 
731  L = axial thread length (mm) including only threads that have the nominal major 
732  diameter where complete purchase is expected (e.g., excluding the screw tip) of 
733  thread engagement in material  
734  Dmajor = major diameter (mm) 
735  TSF = Thread Shape Factor (dimensionless) = (0.5 + 0.57735 d/p) 
736  d = thread depth (mm) = (Dmajor  Dminor)/2 
737  Dminor = minor (root) diameter (mm) 
738  p = thread pitch (mm) 
739 
740  A justification should be provided to support why the evaluated screws selected 
741    are worst case and also for each variable used in the Chapman analysis (e.g., bone 
 
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Draft  Not for Implementation 
 
742  foam per ASTM F1839). Axial pullout performance is heavily influenced by 
743  amount of interface and the failure mechanism at the interface with bone foam. 
744  Factors such as decreasing outer diameter and decreasing axial thread length may 
745  help identify the worst case.  
746   
747  Dimensions used for calculations should be clearly listed for each theoretical 
748  outcome. Dimensional values used in this calculation should be consistent with 
749  the values listed on the screw engineering drawings. 
750  L.  Non-Clinical Animal and/or Clinical Performance Testing 
751  Non-clinical animal studies32 and/or clinical evidence are generally unnecessary for most bone 
752  plates and screws; however, such testing may be requested in situations such as the following:  
753 
 
754    indications for use dissimilar from legally marketed devices of the same type; 
755    new technology, i.e., technology different from that used in legally marketed devices of 
756  the same type (e.g., dynamic or flexible fixation systems that differ in stiffness or 
757  strength to other predicates), yet does not raise different questions of safety or 
758  effectiveness; or 
759    cases where engineering and/or animal testing raise issues that warrant further evaluation 
760  with clinical evidence. 
761   
762  We encourage manufacturers to take advantage of the Q-Submission Program to ensure that the 
763  animal study protocol addresses safety concerns and contains elements which are appropriate for 
764  a regulatory submission. For example, animal studies to determine a devices safety must be 
765  performed under the Good Laboratory Practice (GLP) regulation in 21 CFR Part 58. In addition, 
766  if you are proposing to use a non-animal testing method that you believe is suitable, adequate, 
767  validated, and feasible, we recommend that you discuss the proposal using the Q-Submission 
768  Program. We will consider if such an alternative method could be assessed for equivalency to an 
769  animal test method. For details on the Q-Submission Program, refer to the guidance Requests 
770  for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program.33 
771   
772  We will consider alternatives to clinical testing when the proposed alternatives are supported by 
773  an adequate scientific rationale. If a clinical study is needed to demonstrate substantial 
774  equivalence, i.e., conducted prior to obtaining 510(k) clearance of the device, the study must be 
775  conducted under the Investigational Device Exemptions (IDE) regulation, 21 CFR Part 812. 
776  Generally, we believe bone plates and screws addressed by this guidance document are 
777  significant risk devices subject to all requirements of 21 CFR 812. See the FDA Guidance titled, 
 
32 FDA supports the principles of the 3Rs, to reduce, refine, and replace animal use in testing when feasible. We 
encourage sponsors to consult with us if they wish to use a non-animal testing method they believe is suitable, 
adequate, validated, and feasible. We will consider if such an alternative method could be assessed for equivalency 
to an animal test method. 
33 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/requests-feedback-and-meetings-
medical-device-submissions-q-submission-program. 
 
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778  Significant Risk and Nonsignificant Risk Medical Device Studies.34 In addition to the 
779  requirements of 21 CFR 812, sponsors of such trials should comply with the regulations 
780  governing institutional review boards (21 CFR Part 56) and informed consent (21 CFR Part 50).  
781   
782  When data from clinical investigations conducted outside the U.S. are submitted to FDA for 
783  these devices, the requirements of 21 CFR 812.28 may apply.35 21 CFR 812.28 outlines the 
784  conditions for FDA acceptance of clinical data from investigations conducted outside the U.S. 
785  when submitted to support premarket submissions. For more information, see the FDA guidance 
786  Acceptance of Clinical Data to Support Medical Device Applications and Submissions: 
787  Frequently Asked Questions.36 
788   
789  In some cases, real-world data (RWD) may be used to support expansion of indications, 
790  changes in surgical technique, or changes in design/prominence for a device for which 510(k) 
791  clearance has already been obtained. Whether the collection of RWD for a legally-marketed 
792  device requires an IDE depends on the particular facts of the situation. Specifically, if a cleared 
793  device is being used in the normal course of medical practice, an IDE would likely not be 
794  required. For additional information regarding this topic, please refer to the FDA Guidance 
795  entitled Use of Real-World Evidence to Support Regulatory Decision-Making for Medical 
796  Devices.37 
797  V.  Modifications (Devices subject to 510(k)) 
798  In accordance with 21 CFR 807.87(a)(3), a device change or modification that could 
799  significantly affect the safety or effectiveness of the device or represents a major change or 
800  modification in the intended use of the device requires a new 510(k).38 The changes or 
801  modifications listed below are examples of changes that may require submission of a new 
 
34
 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/significant-risk-and-nonsignificant-
risk-medical-device-studies. 
35 This applies to data from clinical investigations that began on or after February 21, 2019, and are submitted to 
support a premarket submission, including IDEs, premarket approval applications (PMAs), and 510(k)s. 
36 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/acceptance-clinical-data-support-
medical-device-applications-and-submissions-frequently-asked. 
37 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/use-real-world-evidence-support-
regulatory-decision-making-medical-devices. 
38 Section 3308 of the Food and Drug Omnibus Reform Act of 2022, Title III of Division FF of the Consolidated 
Appropriations Act, 2023, Pub. L. No. 117-328 (FDORA), enacted on December 29, 2022, added section 515C 
Predetermined Change Control Plans for Devices to the FD&C Act (section 515C). Under section 515C, FDA can 
approve or clear a predetermined change control plan (PCCP) for a device that describes planned changes that may 
be made to the device and that would otherwise require a supplemental premarket approval application or premarket 
notification. For example, section 515C provides that a supplemental premarket approval application (section 
515C(a)) or a premarket notification (section 515C(b)) is not required for a change to a device if the change is 
consistent with a PCCP that is approved or cleared by FDA. Section 515C also provides that FDA may require that a 
PCCP include labeling for safe and effective use of a device as such device changes pursuant to such plan, 
notification requirements if the device does not function as intended pursuant to such plan, and performance 
requirements for changes made under the plan. If you are interested in proposing a PCCP in your marketing 
submission, we encourage you to submit a Pre-Submission to engage in further discussion with CDRH. See FDAs 
guidance Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program. 
 
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802  510(k). Note that this list is not exhaustive but provides examples of modifications that are likely 
803  to require submission of a new 510(k). For additional details, please see FDA guidance, 
804  Deciding When to Submit a 510(k) for a Change to an Existing Device.39  
805   
806  Such changes or modifications include:  
807   
808    The addition of a thinner or thicker bone plate, or screws with lower pullout strength than 
809  a legally marketed predicate device  FDA considers this change to be a significant 
810  change in design.  These types of changes could significantly affect the safety and 
811  effectiveness of the device by introducing a new potential worst-case scenario for some 
812  failure modes (e.g., mechanical failure of the plate, pain and irritation from prominence, 
813  loss of screw stability). 
814   
815    A change in sterilization method from Established Category A sterilization methods to 
816  Established Category B or Novel sterilization methods  this type of change could 
817  significantly affect the safety and effectiveness of the device by introducing a new or 
818  increased risk of device contamination. See FDAs guidance Submission and Review of 
819  Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled 
820  as Sterile40 for a discussion of sterilization methods. 
821   
822    A change in material   a change in material type (except changes from a weaker 
823  common metal to a stronger common metal, as discussed below), formulation, chemical 
824  composition, or material processing could significantly affect the safety and effectiveness 
825  of the device. The change may introduce new or increased biocompatibility concerns or a 
826  change in the risks associated with device failure. 
827   
828    A change in compatibility of system components  this change could significantly affect 
829  the safety and effectiveness of the device by introducing a new worst-case scenario for a 
830  failure mode or expand the indications for use of a cleared component. 
831   
832  FDA believes that the following modifications would generally not require a new 510(k): 
833   
834    The addition of a bone plate, screw, or washer of identical design, material, and 
835  processing to a legally marketed device, but of an intermediate size because this would 
836  not generally introduce new or significantly modified risks or new worst-case failure 
837  modes. 
838   
839    Modification in the sterilization process from one category A method to another category 
840  A method as defined in FDAs guidance Submission and Review of Sterility 
 
39 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/deciding-when-submit-510k-change-
existing-device. 
40 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/submission-and-review-sterility-
information-premarket-notification-510k-submissions-devices-labeled. 
 
 
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841  Information in Premarket Notification (510(k)) Submissions for Devices Labeled as 
842  Sterile (e.g., steam sterilization, gamma irradiation sterilization), if the change in 
843  sterilization method can be justified as having no significant deleterious effect on the 
844  mechanical or material properties of the device throughout the duration of its shelf life.  
845   
846    A change in material from a weaker common metal to a stronger common metal which 
847  conforms to an FDA recognized standard(s) and has a history of safe use for the same 
848  indications (e.g., change in device from commercially pure titanium to stainless steel per 
849  ASTM F138 or a change from commercially pure titanium to titanium alloy per ASTM 
850  F136) where no new or increased biocompatibility concerns have been introduced. 
851   
852    A change in compatible screws to include larger diameters within the range of legally 
853  marketed screws with the same intended use and anatomical location (e.g., a wrist plating 
854  system cleared with 2.0mm screws is modified to also include a 2.7mm diameter screw of 
855  the same type), if it can be justified that the larger diameter screw does not introduce 
856  changes to the plate interface or other factors affecting worst case.    
 
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APPENDIX A 
857 
Example Table of Plate Test Methods and Data 
858 
Summary 
859 
860   
861  Table A.1  Example summary of test summary information for single cycle bend testing 
862  of plates when performed per ASTM F382 Standard Specification and Test Method for 
863  Metallic Bone Plates. This represents an example of how test summary information may be 
864  organized.  
865   
Predicate 
Worst-Case 
(510(k) 
  Definition  Subject 
submission 
Device 
number) 
Parameter       
Description of  The bone plate thickness, width, 
   
plate  length, and shape. 
The identifying series of letters and 
numbers which is designated to the 
Catalog or part 
worst-case construct used in testing     
number 
and corresponds with the associated 
engineering drawings. 
Plate material 
(include ASTM 
The base material from which the 
or ISO     
components are manufactured. 
specification if 
available) 
Center span  The measured distance between the 
   
length  two loading rollers in the test setup. 
Loading span  The distance between the support 
   
length  roller and the nearest loading roller. 
Loading roller  The diameter of the construct used to 
   
diameter  load the subject plate. 
Control method  The method which is used to 
(displacement  determine failure of the plate has     
or load)  occurred. 
Displacement or  The rate at which the applied load or 
load control  displacement is recorded throughout     
rate utilized  the test simulation. 
Test  The pre-determined displacement or 
termination  load values which are used to     
criteria  determine the test termination. 
Sample size  The number of samples used.     
Results       
 
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Predicate 
Worst-Case 
(510(k) 
  Definition  Subject 
submission 
Device 
number) 
0.2% offset 
displacement 
Permanent deformation equal to 0.2% 
(mean      
of the center loading span distance. 
standard 
deviation) 
Proof load 
(mean   The maximum applied load prior to 
   
standard  plastic deformation of the plate. 
deviation) 
Bending 
A normalized calculation of the plate 
structural 
resistance to bending deformation 
stiffness (mean     
which takes into account the test 
 standard 
setup. 
deviation) 
Bending  The stress required to produce a 
strength (mean  predetermined amount of plastic 
   
 standard  deformation of the plate, such as a 
deviation)  0.2% offset. 
Description of  The predetermined criteria for all 
   
failure modes  methods of failure of the plate. 
866   
867     
 
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APPENDIX B 
868 
Example Table of Screw Test Methods and Data 
869 
Summary 
870 
871   
872  Table B.1  Example summary of test summary information for axial pullout strength 
873  testing of screws when performed per ASTM F543 Standard Specification and Test 
874  Methods for Metallic Medical Bone Screws. This represents an example of how test 
875  summary information may be organized.  
876   
Worst-
Case 
  Definition  Predicate 
Subject 
Device 
Parameters       
The screw length, cannula size, major and 
Description of 
minor thread diameter, threaded length, and     
screw 
pitch. 
The identifying series of letters and numbers 
Catalog or part  which is designated to the worst-case 
   
number  construct used in testing and corresponds with 
the associated engineering drawings. 
Screw material 
(include ASTM 
The base material from which the components 
or ISO     
are manufactured. 
specification if 
available) 
Pilot hole 
diameter (if  The diameter of the hole which is pre-drilled 
applicable per  into the test block into which the screw tip is     
the surgical  inserted. 
technique) 
Description of 
pilot hole  Determination if the pilot hole will require a 
preparation (e.g.,  tap to be inserted into the pilot hole prior to     
is pilot hole pre- the insertion of the screw. 
tapped or not) 
Test block 
The test block Trade Name, material, and 
material     
density. 
description 
Displacement  The rate at which a tensile load is applied to 
   
rate  the screw. 
 
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Worst-
Case 
  Definition  Predicate 
Subject 
Device 
Final insertion  The final depth that the subject screw reaches 
   
depth  into the test block after insertion. 
The distance between the edge of the gripping 
Grip span     
structures holding the test block in place. 
Results       
Axial pullout 
strength (mean   The maximum load achieved before the screw 
   
standard  releases from the test block. 
deviation) 
Description of the  The observed method of failure for the screw 
   
mode of failure  upon release from the test block. 
877   
878  Table B.2  Example summary of test summary information for insertion and removal 
879  torque testing of screws when performed per ASTM F543: Standard Specification and Test 
880  Methods for Metallic Medical Bone Screws. This represents an example of how test 
881  summary information may be organized.  
882   
Worst-Case 
  Definition  Subject  Predicate 
Device 
Parameters       
The screw length, cannula size, 
Description of 
major and minor diameter, threaded     
screw 
length, and pitch 
The identifying series of letters and 
numbers which is designated to the 
Catalog or part 
worst-case construct used in testing     
number 
and corresponds with the associated 
engineering drawings. 
 
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Worst-Case 
  Definition  Subject  Predicate 
Device 
Screw material 
(include ASTM or  The base material from which the 
   
ISO specification  components are manufactured. 
if available) 
Test block 
The test block Trade Name, 
material     
material, and density. 
description 
Number of  The number of revolutions recorded 
   
revolutions  when applying torsional force. 
The rate of insertion/removal 
Test speed  torque recorded throughout the test     
simulation. 
Description of 
Determination if the pilot hole will 
pilot hole 
require a tap to be inserted into the 
preparation (e.g.,     
pilot hole prior to the insertion of 
is pilot hole pre-
the screw. 
tapped or not) 
Determination of axial load to 
Axial load     
insert or remove the screw.  
The final depth that the subject 
Final insertion 
screw reaches into the test block     
depth 
after insertion. 
Sample size  The number of samples used.     
Results       
 
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Worst-Case 
  Definition  Subject  Predicate 
Device 
Insertion/removal  The amount of torque required to 
torque (mean   insert/remove the screw from the 
   
standard  test block during the initial four 
deviation)  revolutions of the screw.   
The observed method of failure for 
Description of 
the screw upon insertion or release     
failure modes 
from the test block. 
883   
884   
885  Table B.3  Example summary of test summary information for torsional strength testing 
886  of screws when performed per ASTM F543: Standard Specification and Test Methods for 
887  Metallic Medical Bone Screws.  This represents an example of how test summary 
888  information may be organized. 
889   
Worst-Case 
  Definition  Subject  Predicate 
Device 
Parameters       
The screw length, cannula size, 
Description of screw  major and minor diameter,     
threaded length, and pitch 
The identifying series of letters and 
numbers which is designated to the 
Catalog or part 
worst-case construct used in testing     
number 
and corresponds with the 
associated engineering drawings. 
Screw material 
(include ASTM or  The base material from which the 
   
ISO specification if  components are manufactured. 
available) 
The length of the screw which is 
Grip Length     
gripped in the test set-up 
The length of the screw shaft 
Exposed Length     
which is exposed to loading 
 
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Worst-Case 
  Definition  Subject  Predicate 
Device 
Control method  The method which is used to 
(displacement or  determine failure of the screw has     
load)  occurred. 
The rate at which the applied load 
Displacement or load 
or displacement is recorded     
control rate utilized 
throughout the test simulation. 
The pre-determined displacement 
Test termination 
or load values which are used to     
criteria 
determine the test termination. 
Sample size  The number of samples used.     
Results       
0.2% offset  Permanent displacement equal to 
displacement (mean  0.002 times the test gage section     
 standard deviation)  length for the specific test. 
The stress required to produce a 
Torsional yield 
predetermined amount of plastic 
strength (mean      
deformation of the screw, such as a 
standard deviation) 
0.2% offset. 
Description of failure  The predetermined criteria for all 
   
modes  methods of failure of the plate. 
890   
 
35