Guidance for Industry and FDA Staff 
Spinal System 510(k)s
Document issued on: May 3, 2004 
This document supersedes Guidance for Spinal System 510(k)s dated 
September 27, 2000.  
For questions regarding this document contact Mr. Theodore Stevens at 240-276-3676 or by email at 
 .t heodore.stevens@fda.hhs.gov
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Devices and Radiological Health 
Orthopedic Devices Branch 
 Division of General, Restorative, and Neurological Devices 
Office of Device Evaluation  Contains Nonbinding Recommendations 
Preface 
Public Comment 
Comments and suggestions may be submitted at any time for Agency consideration to Division of Dockets 
Management, Food and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, 
MD, 20852.  When submitting comments, please refer to the exact title of this guidance document.  
Comments may not be acted upon by the Agency until the document is next revised or updated.   
Additional Copies 
Additional copies are available from the Internet at: http://www.fda.gov/cdrh/ode/guidance/636.pdf, or 
to receive this document by fax, call the CDRH Facts-On-Demand system at 800-899-0381 or 301-
827-0111 from a touch-tone telephone.  Press 1 to enter the system.  At the second voice prompt,
press 1 to order a document.  Enter the document number (636) followed by the pound sign (#).
Follow the remaining voice prompts to complete your request. Contains Nonbinding Recommendations 
Table of Contents 
INTRODUCTION.........................................................................................................................1 
SCOPE............................................................................................................................................2 
SPECIFIC CONTENT FOR SPINAL SYSTEM 510(k).............................................................3 
1. PURPOSE OF YOUR 510(k)...............................................................................................3 
2. DEVICE DESCRIPTION....................................................................................................3 
3. INDICATIONS FOR USE...................................................................................................7 
4. MECHANICAL TESTING..................................................................................................9 
5. WEAR TESTING...............................................................................................................13 
6. ANIMAL STUDIES...........................................................................................................13 
7. CLINICAL STUDIES.........................................................................................................14 
8. STERILITY.........................................................................................................................15
9. MODIFICATIONS TO LEGALLY MARKETED DEVICES:  SPECIAL 510(K)S......15 
10. LABELING.........................................................................................................................15
FREQUENTLY ASKED QUESTIONS......................................................................................17  Contains Nonbinding Recommendations 
Guidance for Industry and FDA Staff 
Spinal System 510(k)s
This guidance represents the Food and Drug Administration's (FDA's) current thinking on 
this topic.  It does not create or confer any rights for or on any person and does not operate to 
bind FDA or the public.  You can use an alternative approach if the approach satisfies the 
requirements of the applicable statutes and regulations.  If you want to discuss an alternative 
approach, contact the FDA staff responsible for implementing this guidance.  If you cannot 
identify the appropriate FDA staff, call the appropriate number listed on the title page of this 
guidance.  
Introduction 
The purpose of this guidance document is to provide updated information regarding premarket 
notification (510(k)s) for spinal systems.  This guidance document supersedes Guidance for Spinal 
System 510(k)s dated September 27, 2000. 
The three primary differences between this version and the September 27, 2000 version are listed 
below. 
1. System types have been redefined based on current indications for use.
2. The MNI product code, previously covering class II, class III preamendments, and unclassified
pedicle screw uses, has been changed as follows: 
 the MNI product code now includes class II pedicle screw uses only
 the NKB product code was developed for the class III preamendments pedicle screw
uses of (1) degenerative disc disease, and (2) spondylolisthesis (other than severe
spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with
objective evidence of neurological impairment, which are both classified into class II as
codified by 21 CFR 888.3070)
 the NKG product code was developed for unclassified cervical pedicle screw uses.
3. Testing recommendations and indications for use for pedicle screw systems have been updated.
This guidance document was developed in response to discussions and correspondence between FDA 
and manufacturers of spinal systems, as well as in response to the publication of a final rule (63 FR 
40025) classifying and reclassifying pedicle screw systems which became effective on August 26, 1998, 
as corrected by a Technical Amendment (66 FR 28501), which became effective on May 22, 2001.  
This guidance document also contains mechanical testing and material characterization input from the 
Orthopedic and Rehabilitation Devices Panel (the Panel) from the November 21, 2002 meeting. 
page 1  Contains Nonbinding Recommendations 
FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. 
 Instead, guidances describe the Agency's current thinking on a topic and should be viewed only as 
recommendations, unless specific regulatory or statutory requirements are cited.  The use of the word 
should in Agency guidances means that something is suggested or recommended, but not required.  
The Least Burdensome Approach 
The issues identified in this guidance document represent those that we believe need to be addressed 
before your device can be marketed.  In developing the guidance, we carefully considered the relevant 
statutory criteria for Agency decision-making.  We also considered the burden that may be incurred in 
your attempt to follow the guidance and address the issues we have identified.  We believe that we have 
considered the least burdensome approach to resolving the issues presented in the guidance document.  
If, however, you believe that there is a less burdensome way to address the issues, you should follow the 
procedures outlined in the document, A Suggested Approach to Resolving Least Burdensome 
Issues.  It is available on our Center web page at:  https://www.fda.gov/downloads/MedicalDevices/
DeviceRegulationandGuidance/GuidanceDocuments/UCM588914.pdf. 
Scope 
A spinal system 510(k) typically involves one of the following: 
 a new spinal system 
 components to be added to a cleared spinal system 
 expansion of indications for use of a cleared spinal system.
This guidance document is applicable to most plate and rod-based spinal systems indicated 
for fusion, as well as vertebral body replacement devices.   
Each rod and plate-based spinal system may be described by one or more system types (e.g., a 
thoracolumbar anterior plate system and pedicle screw system).  The different system types are 
described in more detail in 2.  Device Description. 
This guidance document does not address facet screw fixation systems.  
Although FDA recognizes that facet screw fixation systems were discussed in the 2000 version of 
this guidance document, these systems were removed from this updated version based on the 
limited number of submissions received each year.  While you may use this guidance as a general 
framework for those systems, the Orthopedic Devices Branch is available to advise you further 
regarding your facet screw fixation system. 
This guidance document also does not address interbody fusion and non-fusion devices 
(i.e., cages or disc replacement devices) or other nonfusion spinal devices.   
These devices are Class III devices and require the submission of premarket approval applications 
(PMAs) before they may be marketed.  Studies of these devices must be conducted under the 
Investigational Device Exemptions (IDE) regulation, 21 CFR Part 812.  FDA believes that these 
page 2  Contains Nonbinding Recommendations 
devices are significant risk devices as defined in 21 CFR 812.3(m).1  In addition to the requirement 
of having an FDA-approved IDE, sponsors of such trials must comply with the regulations 
governing institutional review boards (21 CFR Part 56) and informed consent (21 CFR Part 50).  
This guidance document contains information specific to spinal system 510(k)s.  This document 
supplements other FDA documents regarding the content requirements of a 510(k) submission.  You 
should also refer to CDRHs Device Advice http://www.fda.gov/cdrh/devadvice/ and 21 CFR 807.87. 
 For general orthopedic 510(k) guidance, we recommend that you refer to the Guidance Document 
for the Preparation of Premarket Notification [510(K)] Applications For Orthopedic Devices 
that is available at http://www.fda.gov/cdrh/ode/832.pdf.   
Specific Content for Spinal System 510(k)s 
As stated above, this guidance document supplements other FDA documents regarding the information 
to be included in a 510(k) submission in accordance with 21 CFR 807.87.  In addition to the general 
information, we recommend that you provide the following specific information for each spinal system 
510(k) in the following order and format for ease of review. 
1. Purpose of Your 510(k)
We recommend that you clearly state the purpose of your 510(k).  For example, you should state 
whether your 510(k) seeks clearance for a new spinal system, adds a new component to a cleared 
spinal system, or proposes other modifications.  
If your 510(k) is for a new spinal system, we recommend that you provide the name of the spinal 
system you intend to use for labeling purposes.  If the 510(k) involves an expansion of components 
or indications for use of a cleared spinal system, we recommend that you identify the name of the 
spinal system being expanded and provide the number of the most recent 510(k) cleared for that 
spinal system. 
2. Device Description
Defining System Type 
Multiple regulations and product codes may be used to define a given system.  FDA, however, 
has re-evaluated the manner in which we define a system type.  FDA has traditionally focused on 
product code to define a system type.  We believe that it will be easier to define a system type by 
its indication for use (e.g., anterior cervical fixation).   
As stated in the Introduction section above, FDA developed new product codes for the different 
types of pedicle screw fixation, primarily to distinguish the different classes of pedicle screw use 
(i.e., class II, class III preamendments, and unclassified).  Pedicle screw fixation systems are 
1 Refer to Blue Book Memorandum entitled Significant Risk And Nonsignificant Risk Medical 
Device Studies at http://www.fda.gov/cdrh/d861.html. 
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covered by product codes MNH, MNI, NKB, and NKG.  The majority of the pedicle screw 
systems reviewed by FDA are covered by what would be currently defined as product codes 
MNH, MNI, and NKB.   
In the past, the list of indications for use for a spinal system has because it included statements for 
each product code that a system fit.  FDA has reviewed the available data for pedicle screws for 
the indication of degenerative disc disease and other spondylolistheses (spondylolisthesis uses not 
covered by MNI and MNH).  After careful consideration, we believe that degenerative disc 
disease and other spondylolistheses can be included as part of the standard list of indications 
allowed for posterior, noncervical pedicle screw systems and that these indications fall within the 
intended use.  Moreover, we believe these indications are well-supported and generally will not 
recommend clinical studies in new 510(k) submissions unless the design, technology, or 
indications are sufficiently dissimilar from legally marketed systems.  By combining the pedicle 
screw indications covered by systems with product codes of MNH, MNI, and NKB, we now 
have one set of indications for a posterior, noncervical, pedicle screw spinal system.  Systems 
with the product code of MNH were previously limited to specific types of spondylolisthesis in the 
lumbar spine but will now include all types of spondylolisthesis at all noncervical levels under the 
general indication of spondylolisthesis.    
Moreover, the set of indications for a noncervical, pedicle screw system now parallels the 
indications for use of anterior and posterior, nonpedicle cervical systems.  This greatly simplifies 
the statement of uses necessary for a given system. 
Table 1a and Table 1b below summarizes for each spinal system that is subject to this guidance 
document, the product code the indications for use, class, and classification identification 
associated with that system.  Table 1a details cervical systems and Table 1b details non-cervical 
systems. 
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Table 1a.  Summary of Cervical System Types, Product Codes, and Indications for Use  
System Type  Product  Indications for Use  Class  Classification 
(Indication for Use)  Code  IdentificationA 
Anterior Cervical  KWQ   degenerative disc II  888.3060 
System  diseaseB
 spondylolisthesis
 trauma (i.e., fracture or
dislocation)
 spinal stenosis
 deformities or curvatures
(i.e., scoliosis, kyphosis,
and/or lordosis)
 tumor
 pseudoarthrosis
 failed previous fusion
Posterior, Cervical,  KWP  same as KWQ above  II  888.3050 
Nonpedicle System 
(e.g., occipital system) 
Cervical, Pedicle  NKG   cervical spondylolisthesis
System  (all grades and types) UnclassifiedC 
 cervical spondylolysis
 cervical degenerative disc
diseaseB
 degeneration of the
cervical facets
accompanied by instability
 cervical trauma (fracture
and dislocation)

revision of failed previous
fusion surgery
(pseudoarthrosis) of the
cervical spine
A Sections cited refer to Title 21 of the Code of Federal Regulations (CFR). 
B You should include the definition for degenerative disc disease (DDD) as part of any statement of 
uses.  DDD for cervical systems is defined as neck pain of discogenic origin with degeneration of the 
disc confirmed by history and radiographic studies.   
C The regulatory pathway, i.e., premarket notification submission (510(k)), de novo classification, or 
premarket approval application (PMA), for device depends on the identification of an appropriate 
predicate device, the technology of the device, and its indications for use.  See also New Section 
513(f)(2) - Evaluation of Automatic Class III Designation, Guidance for Industry and 
CDRH Staff at https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/
GuidanceDocuments/ucm080197.pdf and Premarket Approval at 
http://www.fda.gov/cdrh/devadvice/pma/ 
page 5  Contains Nonbinding Recommendations 
Table 1b.  Summary of Non-Cervical System Types, Product Codes, and Indications for Use 
System Type  Product  Indications for Use  Class  Classification 
Code(s)  IdentificationA 
Anterior/ Anterolateral,  KWQ   degenerative disc diseaseB II  888.3060 
Noncervical System   spondylolisthesis
 trauma (i.e., fracture or
dislocation)
 spinal stenosis
 deformities or curvatures
(i.e., scoliosis, kyphosis,
and/or lordosis)
 tumor
 pseudoarthrosis
 failed previous fusion 
Posterior, Noncervical,  KWP  same as KWQ above  II  888.3050 
Nonpedicle System 
Noncervical, Pedicle  MNH  same as KWQ above  II  888.3070(b)(1) 
System  MNI  II  888.3070(b)(1) 
NKBC  III  888.3070(b)(2) 
Vertebral Body  MQP   tumor II  888.3060 
Replacement   trauma/fracture
Device/System 
A Sections cited refer to Title 21 of the CFR. 
B You should include the definition for degenerative disc disease (DDD) as part of any statement of 
uses.  DDD for noncervical systems is defined as back pain of discogenic origin with degeneration of the 
disc confirmed by history and radiographic studies.  
C Systems intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, 
and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and 
spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative 
spondylolisthesis with objective evidence of neurologic impairment are class III.  21 CFR 
888.3070(b)(2)  You must provide a Class III Summary and Certification with your 510(k) in 
accordance with 21 CFR 807.87(j)(2) and 21 CFR 807.94. 
Once you have determined the system type(s) and corresponding product code(s), indication(s) 
for use, class(es), and regulation number(s) appropriate for your system, we recommend that you 
clearly state this information at the beginning of your submission.   
Specific Device Description Information 
Depending on the system type involved, a given spinal system may consist of rods or plates, 
anterior screws, pedicle screws, sacral/iliac screws, hooks, connectors, crosslinks, fasteners, etc. 
We recommend that you provide the following device description information: 
 a table of components (see below for what should be included in this table)
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 complete, dimensioned engineering drawings of each subject component
 a written description of the individual components and how the subject components
interconnect (e.g., diameter of rods, sizes of screws, size/thickness of anterior plates,
geometry of vertebral body replacement, type of screw/rod interconnection).  Supporting 
sketches and/or photographs of the interconnection mechanisms may be useful
 a comparison of the largest profile of the device compared to a predicate device (if the
device is implanted anteriorly or anterolaterally)
 identification of the materials from which the subject components are manufactured and
any voluntary material standards to which these materials conform 
 a magnified photograph and/or sketch of the spinal system attached to a spinal model 
 information on the surgical instruments considered unique to the implantation of the subject
system (i.e., list of surgical instruments, photograph(s)/drawing(s) of each, identification of
materials from which they are manufactured, and any voluntary material standards to
which these materials conform).
Table of Components 
We recommend that you provide a table of components with your 510(k), whether it involves a 
new system or an addition of components or indications to a cleared system.  The table should be. 
 For a 510(k) involving an expansion of an already cleared spinal system (whether an expansion 
of components or indications for use), we recommend that you provide an all-inclusive list of 
components previously cleared and those under review for the given spinal system highlighting the 
components that have been added.   
We recommend that you stratify the table into sections that are appropriate for the given system 
(e.g., by material, vertical rod diameter, anterior versus posterior components).  Table 2 is an 
example of a component table. 
Table 2.  Sample Table of Components 
Component Name  Part Number  Sizes (lengths  Levels of  510(k) 
and diameters)  Attachment  numberA 
Offset sacral  xx.xxx XXmm- L1-L5  KXXXXXX 
screw  XXmm 
A 510(k) in which component was cleared as part of the subject system or identification of the 
component as new 
Please see Frequently Asked Questions at the end of this document for questions related to 
specific materials and other material questions. 
3. Indications for Use
We recommend that you explicitly state the indication(s) for use for each spinal system at the 
beginning of your submission.  We suggest that you avoid general and/or open-ended indications 
page 7  Contains Nonbinding Recommendations 
(e.g., instability, disc herniation, or general spinal curvature).  A single spinal system may have 
several sets of indications for use.  However, based on FDAs re-evaluation of the system types 
and indications, the indication for use that appears in the labeling should be significantly clearer and 
more concise. 
Below are examples of indication for use statements: 
Example for anterior cervical system (product code KWQ): 
The X System is intended for anterior cervical fixation for the following indications: 
degenerative disc disease (DDD) (defined as neck pain of discogenic origin with 
degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, 
trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., 
scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion. 
Example for posterior thoracolumbar system (product codes KWP, MNI, MNH, NKB): 
The X System is intended for posterior, noncervical pedicle and non-pedicle fixation for the 
following indications: degenerative disc disease(DDD) (defined as back pain of discogenic 
origin with degeneration of the disc confirmed by history and radiographic studies); 
spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., 
scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. 
Example for anterior/anterolateral and posterior thoracolumbar system (product codes KWQ, 
KWP, MNI, MNH, NKB):   
The X System is intended for anterior/anterolateral and posterior, noncervical pedicle and 
non-pedicle fixation for the following indications: degenerative disc disease (DDD) 
(defined as back pain of discogenic origin with degeneration of the disc confirmed by 
history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); 
spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; 
pseudoarthrosis; and failed previous fusion. 
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4. Mechanical Testing
General Information 
We recommend that you include mechanical testing or provide a rationale why mechanical testing 
is not necessary to support the substantial equivalence of your new component or system.  Some 
rationales for not performing mechanical testing may involve the expansion of your spinal system 
to include additional components with the same interconnection mechanism, the use of 
components already part of that system, or the addition of components that do not cause the 
system to be susceptible to loosening or failure. 
We recommend that you perform all testing on spinal assembly system constructs comprised of 
components in worst case (e.g., most likely to loosen or fail) final design version.  You should also 
provide a rationale identifying how you identified the worst case spinal assembly.  The 
components tested should comprise of the worst case constructs in terms of design, 
interconnection mechanism, materials, manufacturing-related processing, etc.  We also 
recommend that you conduct testing on components with mechanical properties that could be 
affected by sterilization only after sterilization.  Testing should involve the worst case construct of 
the total system, unless you have provided an adequate rationale for testing only individual 
components.  
The Orthopedics Devices Branch is available to answer your questions about proposed testing 
set-ups to address a specific spinal system, identification of worst case constructs, or additional 
testing for a particular device.  
Specific Testing Information 
Table 3a and Table 3b below identify the type of mechanical testing that we recommend that 
you provide for each system type.  However, depending on the specific design (e.g., anterior cord 
design), material (e.g., polymer, composite), and/or method of attachment, we may recommend 
additional testing (e.g., dynamic torsion testing, creep testing, subsidence testing) for a system.  
Refer to Fatigue and Static Testing Descriptions below for additional details regarding these 
types of tests.  Refer to Test Report below for a description of the information you should include 
in a test report. 
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Table 3a.  Testing Recommended for Cervical Spinal Systems 
Product  Recommended Additional 
System Type  Recommended Testing 
Code  Information 
Anterior,  KWQ   Static and dynamic axial  A statement clarifying
Cervical  compression bending whether the system is
System  testing intended for unilateral and/or
bilateral fixation 
 Static torsion testing
 A comparison of the worst
case constructs width and
prominence to a predicate
system
Posterior  KWP   Static and dynamic axial N/A 
Cervical,  compression bending
Nonpedicle  testing
SystemA
 Static and dynamic torsion 
testing
Cervical, Pedicle  NKG  See KWP above  Clinical Studies 
System 
A If the system attaches to the occiput, we recommend that you provide dynamic torsion testing.  
In addition, a modified version of ASTM F1717 is recommended for testing constructs that are 
intended to be connected to the occiput.  The Orthopedics Devices Branch is available to answer 
your questions about how we recommend that your system be tested. 
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Table 3b.  Testing Recommended for Non-Cervical Spinal Systems 
System Type  Product  Recommended Testing  Recommended Additional 
Code  Information 
Anterior,  KWQ   Static and dynamic axial  A statement clarifying whether
Noncervical  compression bending testing the system is intended for
System  unilateral and/or bilateral
 Static torsion testing
fixation 
 A comparison of the worst
case constructs width and
prominence to a predicate
system 
Posterior  KWP   Static and dynamic axial N/A 
Noncervical,  compression bending testing
Nonpedicle 
 Static torsion testing
System 
Noncervical,  MNI   Static and dynamic axial N/A 
Pedicle System  MNH  compression bending testing
NKB 
 Static torsion testing
Vertebral Body  MQP   Static and dynamic axial  Depending on the design of
Replacement  compression bending testing the VBR system, we may
Device/System  recommend additional testing
 Static and dynamic torsion testing
(VBR)  (e.g., shear loading of a
 Expulsion A composite material, off-axis
compression loading)
For the dynamic axial compression 
 A clinical rationale for all sizes
bending tests, we recommend that you 
of the proposed VBR
meet one of the following conditions: 
 asymptotic load level 
3000N (~2x the vertebral body
compression strength) at 5 x 106
cycles
 asymptotic load level 
1500N (~1x the vertebral body
compression strength) at 10 x 106
cycles
A Expulsion testing may not be necessary for a VBR system that incorporates a supplemental fixation 
system that is physically attached to it (e.g., by a threaded bolt). 
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Static and Fatigue Testing Descriptions 
Static construct testing should involve six or more samples of the worst case construct.  We 
recommend that you provide the rationale for the components tested, loading mode, and testing 
configuration and environment (if applicable). 
Fatigue construct testing is most commonly performed in accordance with American Society for 
Testing and Materials (ASTM) F1717  01 Standard Test Methods for Static and Fatigue 
for Spinal Implant Constructs in a Vertebrectomy Model.  Except as noted below, we 
recommend that you use ASTM F1717 to provide a standard comparison to predicate device 
testing and to allow a declaration of conformity to that standard.  However, you may choose 
alternative test methods that you show are substantially equivalent to the ASTM standard to 
address the mechanical loading issues at hand.  ASTM F1717 is based on metallic spinal systems 
and may not be applicable to systems made out of other materials.  Therefore, we may 
recommend additional testing and/or modifications to ASTM F1717 if the new system is 
manufactured out of a polymer or other materials. 
The fatigue construct testing should involve six or more samples of the worst case construct to 
generate an Applied Force vs. Number of Cycles (AF/N) curve that characterizes the asymptotic 
endurance limit at a runout value of five million cycles compared to an appropriate predicate 
system.  FDA recognizes that ASTM F1717 recommends a Stress versus Log number of cycles 
(S/N) curve; however, we believe that an AF/N curve provides similar information.  We 
recommend that you test two or more samples at the lowest load level in order to establish a 
resulting endurance load limit.   
Test Report 
We recommend that you provide a complete test report that includes the following information: 
 identification of the components that comprised the constructs or subconstructs tested
 the rationale for why those components comprised the worst case constructs or
subconstructs
 the rationale for the loading modes chosen (e.g., axial, bending, torsion)
 identification of testing configuration and environment and a rationale for why that
configuration and environment were chosen
 the results
 a discussion of the results in terms of the expected in vivo and clinical performance of
the assembly
 if there are differences between the subject system and the system actually tested (e.g.,
tests performed on prototype), an explanation of how or why the results are relevant in
supporting a substantial equivalence determination.
Please see Frequently Asked Questions at the end of this document for additional testing 
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information. 
 
5.  Wear Testing 
We recommend that you provide wear testing for a spinal system that raises issues of particulate 
generation (e.g., manufactured from novel materials (e.g., polymers, composites) or those containing 
articulating device components).  We recommend that all wear testing be compared to a legally 
marketed predicate device with the same technological features and indications for use.  You may 
be able to generate and evaluate wear debris as part of the fatigue testing or as part of a functional 
animal model.  We recommend that the system be weighed before and after testing to evaluate mass 
loss during testing.  We also recommend that you characterize all wear particulates (e.g., particle 
size and shape distribution, number of particles, and chemistry of particles) and analyze the 
articulating surfaces for scratches, burnishing, deformation, or any corrosion.  
 
6. Animal Studies 
For most spinal systems, animal studies are generally not necessary to assess the performance of 
these devices.  However, the following are examples of certain circumstances under which FDA 
may recommend that you provide a complete report of animal testing: 
  if the device has new or different indications 
  if the device has novel design features 
  if the device produces wear debris in differing amounts, size, or geometry during wear 
testing than the predicate device 
  if the material has not been evaluated in the spine and/or the effects of the material on 
the spinal area and surrounding tissues and organs have not been evaluated 
  if mechanical testing results do not compare favorably to the predicate device  
  if mechanical testing alone cannot adequately characterize the device. 
 
Animal studies are typically conducted to evaluate a biological response to a new material in the 
spine or to evaluate the functional behavior of a device system.  If a system is manufactured from a 
material not currently used in the spine, or if it contains a component manufactured from a material 
that raises concerns of local and systemic adverse effects, we recommend that you conduct animal 
studies evaluating the biological effects of the material.  FDA also recommends that you use a 
functional animal model to evaluate the actual use of the device system in situations where questions 
of device performance cannot be adequately answered by mechanical testing alone. 
 
For functional animal studies, we recommend that you perform all testing on device components that 
are in final design and sterilized.  However, for animal studies evaluating only the biological response 
of a new material with no device design and function issues, testing on the final, sterilized material 
may be adequate.  For both types of animal studies, FDA recommends that a control group of 
animals be evaluated at the same timepoints as the investigational animals. 
 
We recommend that you include the following information: 
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 identification of the animal model
 the rationale for why the animal model was chosen (e.g., relevance to human anatomy 
or disease)
 identification of the device components (i.e., what components were tested) or particles
(i.e., size, quantity, and quality of particulates) used in the test
 the rationale for why those device components/particles were selected
 the evaluation timepoints of the study 
 the number of animals (control and investigational) evaluated at each timepoint
 identification of the test control
 the results
 a discussion of the results in terms of the expected in vivo and clinical behavior of the
device.
For a functional animal study, we recommend that all testing involve the worst case construct of the 
total system, rather than testing of individual components, unless an adequate rationale is provided.  
When there are differences between the subject system and the system actually tested (e.g., tests 
performed on prototype), you should provide an explanation of how or why the results are relevant 
to assessing the device. 
7. Clinical Studies
In accordance with the Least Burdensome provisions of the Act, FDA will rely upon well-designed 
bench and/or animal testing rather than requiring clinical studies for a spinal system, unless there is a 
specific rationale for asking for clinical information to support a determination of substantial 
equivalence.  For most spinal systems, a clinical study is generally not necessary to support a 
substantial equivalence determination.  However, we may recommend that you conduct a 
supporting clinical study if your device has new uses, novel design features, or mechanical testing 
results that do not compare favorably to the predicate device. 
For spinal systems with the product code NKG, we recommend a clinical study to support a 
substantial equivalence determination.  Studies of these devices must be conducted under the 
Investigational Device Exemptions (IDE) regulation, 21 CFR Part 812.  FDA believes that these 
devices are significant risk devices as defined in 21 CFR 812.3(m).  In addition to the requirement 
of having an FDA-approved IDE, sponsors of such trials must comply with the regulations 
governing institutional review boards (21 CFR Part 56) and informed consent (21 CFR Part 50).  
For information regarding clinical studies for spinal systems, we recommend that you refer to the 
Guidance Document for the Preparation of IDEs for Spinal Systems that is available at 
http://www.fda/gov/cdrh/ode/87.pdf.  The Orthopedics Devices Branch is available to discuss your 
IDE protocol or your plans to conduct clinical studies outside the US.   
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8. Sterility
We recommend that you provide sterilization information for the finished spinal component or 
system in accordance with the Updated 510(k) Sterility Review Guidance K90-1; Final 
Guidance for Industry and FDA that is available at 
https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/
GuidanceDocuments/ucm109897.pdf
.9   . Modifications to Legally Marketed Devices:  Special
510(k)s
Under The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial 
Equivalence in Premarket Notifications; Final Guidance, 
http://www.fda.gov/cdrh/ode/parad510.html, a manufacturer may submit a Traditional 510(k) or 
has the option of submitting a Special 510(k) for certain modifications of legally marketed devices.  
A manufacturer considering modifications to its own cleared device may lessen the regulatory 
burden by submitting a Special 510(k). 
10.Labeling
The premarket notification should include labeling in sufficient detail to satisfy the requirements of 21 
CFR 807.87(e).  The following suggestions are aimed at assisting you in preparing labeling that 
satisfies the requirements of 21 CFR Part 801.2 
Package Label 
We recommend that you include the following items on your package label: 
 component name
 statement referring to package insert for labeling limitations (e.g., "see package insert for
labeling limitations")
 part number/lot number (if applicable)
 shelf life (if applicable)
 material 
 sterile or non-sterile notation.
Package Insert 
We recommend that you include the following information in your package insert: 
 system name
2 Although final labeling is not required for 510(k) clearance, final labeling must comply with the 
requirements of 21 CFR Part 801 before a device is introduced into interstate commerce.  In addition, 
final labeling for prescription devices must comply with 21 CFR 801.109.  Labeling recommendations in 
this guidance are consistent with the requirements of part 801. 
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  specific indications for use, including levels of fixation 
  precaution statement addressing the relationship between fatigue testing and device 
performance, for example: Based on the fatigue testing results, the physician/surgeon 
should consider the levels of implantation, patient weight, patient activity level, other 
patient conditions, etc. which may impact on the performance of the system. 
  sterile or nonsterile notation 
  recommended sterilization process parameters if the device is provided nonsterile or if 
resterilization is allowed. 
 
We also recommend that you include a brief device description with identification of material(s).  
This description should clearly identify any trade name components from other spinal systems that 
are used with the subject system.  For vertebral body replacement systems, the device description 
should also identify each specific supplemental fixation system indicated for use with and/or 
attached to the subject system. 
 
If your system is intended only for uses identified with KWQ or KWP product codes, we 
recommend that you include a warning addressing some of its limitations, for example:  
 
Warning:  This device is not intended for screw attachment or fixation to the posterior 
elements (pedicles) of the cervical, thoracic, or lumbar spine. 
 
However, if your system has pedicle screw uses (MNI, MNH, NKB product codes) with or 
without KWP or KWQ product code uses, the following warning and precaution must be 
included in your package insert (21 CFR 888.3070): 
Warning:  The safety and effectiveness of pedicle screw spinal systems have 
been established only for spinal conditions with significant mechanical instability 
or deformity requiring fusion with instrumentation.  These conditions are 
significant mechanical instability or deformity of the thoracic, lumbar, and sacral 
spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 
vertebra, degenerative spondylolisthesis with objective evidence of neurological 
impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed 
previous fusion (pseudoarthrosis).  The safety and effectiveness of these devices 
for any other conditions are unknown. 
and 
Precaution:  The implantation of pedicle screw spinal systems should be 
performed only by experienced spinal surgeons with specific training in the use of 
this pedicle screw spinal system because this is a technically demanding procedure 
presenting a risk of serious injury to the patient. 
 
Depending on the performance of your device, FDA may recommend that you include additional 
information, warnings, or precautions in the package insert. 
 
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Surgical Technique Manual 
We recommend that you provide a draft surgical technique manual if the system has unique design 
features, such as a vertebral body replacement (MQP product code).  Generally, we recommend 
that the surgical technique manual include the following information: 
  a list of the intended uses and indications, device description, contraindications, 
precautions, and warnings associated with the subject system 
  interconnection and spinal attachment instructions 
  supporting magnified sketches of the major steps 
  identification of each supplemental fixation system used with or attached to the subject 
system (specific to vertebral body replacement systems) 
  removal or revision procedures. 
 
Frequently Asked Questions 
The following frequently asked questions are provided to further assist you in developing a spinal system 
510(k). 
 
1.  How do I determine what is my worst case construct? 
The most appropriate worst case spinal assembly construct typically depends on the device design and 
the test.  The test being done may determine which component should be the weakest or most failure-
prone part of the construct.  We recommend that you explain how each component was chosen for 
each worst case construct.  In addition, you may test the different interconnection mechanisms in the 
same construct or each in a separate construct.  However, we recommend that you test each 
interconnection mechanism or provide an adequate rationale for those not tested. 
 
Typical examples of worst case constructs are listed below.  
 
Pedicle screw, rod, and hook type systems  
We recommend that you evaluate the smallest diameter rod and smallest diameter screws as worst 
case for static and fatigue testing.  Cross-connectors should be used in both static and dynamic 
compression bending tests, but should not be used in static torsion tests.  In addition, for static and 
dynamic testing, we recommend you provide a rationale for testing or not testing the transverse 
connector.   
 
Vertebral body replacements  
We recommend that the tallest components with the smallest cross sectional area be evaluated 
without supplemental fixation for all compression bending tests and torsion tests.  We recommend 
that you evaluate the components with the smallest cross sectional area in all compression tests. 
 
2.  What should I provide if my vertebral body replacement does not perform as 
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recommended by this guidance? 
If your VBR does not perform as recommended in Table 3b, you should test the worst case vertebral 
body replacement in conjunction with the worst case supplemental fixation system for which it is 
intended to be used.  You should identify that as the only system indicated for use in conjunction with 
the VBR.  In addition, we recommend that you provide the 510(k) number for each system tested with 
the VBR.   
 
3.  What type of information should I provide if my spinal system contains polyethylene or 
some other polymer? 
If the system or any component of the system is manufactured from Ultra High Molecular Weight 
Polyethylene, we recommend that you provide the information detailed in the guidance entitled, Data 
Requirements for Ultrahigh Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic 
Devices that is available at http://www.fda.gov/cdrh/ode/180.pdf. 
 
If the system or any component of the system is manufactured from any other polymer (e.g., 
Polyetheretherketone), we recommend that you provide a characterization of the material (e.g., 
biocompatibility information and/or leachables, material properties, molecular weight, molecular weight 
distribution, chemical and crystal structures, percent of crystallinity, the degree of cross-linking of that 
polymer) for the raw material, as well as the final sterilized material.  In addition, we recommend that 
you provide a brief summary of the material processing and any solvents used throughout the 
manufacturing of the components or spinal system. 
 
For any materials that are manufactured from polymers or that have the potential for leachables, you 
should perform an exhausted extraction analysis of the final sterilized device.  Extractions should be 
done using both a polar (e.g., saline) and a non-polar solvent (e.g., hexane, acetonitrile).  Some solvents 
may be appropriate for certain materials; you should provide a rationale for the solvents chosen for the 
extraction tests.  The test report should include, but need not be limited to, the instrument sensitivities, 
type of solvent used, the amount of leachables and impurities detected at part-per-billion (ppb) levels, 
etc.  We recommend that you identify each leachable and impurity that is detected qualitatively and 
quantitatively, including any low molecular weight materials, residual monomers, solvent, sulfur contents, 
catalysts, initiators, lubricants, etc.  
 
We may also recommend general biocompatibility testing based on the material(s) used to comprise the 
system.  International Standards Organization (ISO) 10993 is a recognized standard that can be 
referenced for a description of the type of information that should be provided to address 
biocompatibility.  Please refer to the guidance entitled, Use of International Standard ISO-10993, 
'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing at the following web 
site for additional information:  http://www.fda.gov/cdrh/g951.html. 
 
In addition, we may recommend animal testing involving the response to the material in the spine (see 6. 
 Animal Studies).   
 
If the system or any component of the system is manufactured from a material that may be affected by 
aging, we recommend you provide a material characterization and possible mechanical testing evaluating 
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the aging effects.  We recommend that you perform chemical analyses to characterize the material per 
the parameters outlined above.   
 
If the identical material is used in a predicate device with the same indications and spinal levels, you may 
identify the predicate device in lieu of providing the above information.  You should submit a direct 
material comparison between the predicate device and your device showing that both devices are 
manufactured from identical materials. 
 
4.  Can I submit one 510(k) that affects more than one spinal system? 
FDA generally recommends that you submit separate 510(k)s for each spinal system because of the 
number and diversity of components contained in each system or when these systems have different 
indications or are supported by information.  Another example where separate 510(k)s are appropriate 
is for the addition of a component to several different spinal systems.  Here again the diversity of 
indications and supporting information will likely make a bundled 510(k) unnecessarily burdensome.  
However, bundling of class I or II spinal implant made of different metallic alloys (e.g., a stainless steel 
and titanium version) into one 510(k) may be appropriate, if the indications for use are generally the 
same for the two materials.  For additional information about bundling, see the guidance entitled 
Bundling Multiple Devices or Multiple Indications in a Single Submission 
http://www.fda.gov/cdrh/mdufma/guidance/1215.html. 
 
5.  What should I do if my spinal system contains components from another one of my 
previously cleared spinal systems? 
If your system (System X) includes components cleared in another one of your own systems (System 
Y), we recommend that you clearly state in the subject 510(k) whether the System Y components will 
keep their original cleared trade name or whether they will be relabeled to reflect the System X trade 
name.  Additionally, we recommend that you include the components for System Y in the table of 
components for System X.   
 
If you choose to keep the original cleared System Y trade name, then the table listing should reflect that 
trade name.  You should provide the device description information described above for these 
components, specific to the use with the new system (System X).   
 
6.  What should I do if my device can be affected by aging or shelf life? 
We recommend you evaluate all spinal systems or spinal components (e.g., polymers) that can be 
affected by shelf life or aging.  You should characterize the material before and after aging to see if aging 
altered the material structure (e.g., molecular weight distribution, crystallinity, cross-linking).  The 
material in this study should be the material used in the final design and should be sterilized using the 
same method as intended for the marketed device.  See 2.  Device Description for material 
properties.  You should choose a validated method of aging.  If shelf life or aging affects the 
components material, you should perform mechanical testing of that component or system using the 
same mechanical tests performed before the device was aged.  
 
If FDA has cleared a 510(k) that contains aging testing on the identical material for the same indications 
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and same spinal levels, you may reference that 510(k) and those material evaluations instead of 
providing the characterization studies described.  In this case, we recommend that you provide a direct 
comparison of the identity, composition, and grade of the materials used in the cleared device and your 
device, showing that they are comprised of the identical materials for the same indications. 
 
7.  What if my 510(k) only involves the addition of new components, such as smaller screws?  
Although we generally recommend construct testing, if you are adding a new component to an already 
existing spinal system (e.g., a component with a different interconnection mechanism) that could create a 
potentially weaker system, we recommend that you test an assembly of those components and compare 
the results to an already cleared assembly of similar components.  We recommend ASTM F1798  97 
Standard Guide for Evaluating the Static and Fatigue Properties of Interconnection 
Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants for assembly test 
methodology.  For the addition of a new component, where it is clear that a potentially weaker system 
will not be created, we continue to recommend construct testing. 
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