Contains Nonbinding Recommendations 
Classification of Posterior Cervical 
Screw Systems: Small Entity 
Compliance Guide 
Guidance for Industry and 
Food and Drug Administration  Staff 
Document issued on May 4, 2020. 
For questions about this document, contact Regulations,  Policy, and Guidance Staff by email at 
RPG@fda.hhs.gov. 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Devices and Radiological Health  Contains Nonbinding Recommendations 
Preface 
 
Public Comment 
 
You may submit electronic comments and suggestions at any time for Agency consideration  to 
https://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.   
 
Identify all comments with the docket number FDA-2015-N-3785. 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. You may also send an e-mail request to 
CDRH-Guidance@fda.hhs.gov  to receive a copy of the guidance. Please include the document 
number 20008 and complete title of the guidance in the request. 
    Contains Nonbinding Recommendations 
Classification of Posterior Cervical 
Screw Systems: Small Entity 
Compliance Guide 
 
Guidance for Industry and 
Food and Drug Administration  Staff 
 
This guidance represents the current thinking of the Food and Drug Administration (FDA or 
Agency) on this topic.  It does not establish any rights for any person and is not binding on FDA or 
the public.  You can use an alternative approach if it satisfies the requirements of the applicable 
statutes and regulations.  To discuss an alternative approach, contact the FDA staff or Office 
responsible for this guidance as listed on the title page.  
 
I.  Introduction 
On April 1, 2019, FDA published  a final rule in the Federal Register entitled Classification 
of Posterior Cervical Screw Systems (84 FR 12088). This final rule created the 
classification  regulation 21 CFR 888.3075 for posterior cervical screw systems and 
established special controls. FDA has prepared this Small Entity Compliance Guide in 
accordance with section 212 of the Small Business Regulatory Enforcement Fairness Act 
(Public Law 104-121,  as amended by Public Law 110-28) to assist small entities to comply 
with the requirements established in 21 CFR 888.3075. 
 
FDA's guidance documents, including  this guidance, do not establish legally  enforceable 
responsibilities.  Instead, guidances describe the Agencys 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 guidance means that 
something is suggested or recommended, but not required.   
 
II.  Background 
Prior to the classification,  FDA regulated posterior cervical screw systems as unclassified 
preamendments devices requiring  premarket notification  (510(k)).  
 
On April 9, 2009, FDA published  an order under sections 515(i) and 519 of the FD&C Act 
(515(i) order) for the submission  of safety and effectiveness information  on pedicle screw 
spinal systems with certain indications  for use (74 FR 16214).  In response to that order, 
FDA received a request from the Orthopedic Surgical Manufacturers Association (OSMA) to 
1  Contains Nonbinding Recommendations 
classify posterior cervical screw systems into class II (special controls).  Because this request 
was considered to be outside the scope of the 515(i) order related to pedicle screw spinal 
systems, FDA requested that OSMA submit a separate petition  for classification  of posterior 
cervical screw systems. OSMA submitted the requested petition  on November 22, 2011, 
under Docket No. FDA-2011-P-0851. FDA convened an advisory committee meeting of the 
Orthopaedic and Rehabilitation  Devices Panel (the Panel) regarding the classification of this 
device type on September 21, 2012. At that meeting, the Panel recommended that posterior 
cervical screw systems be classified as class II with special controls. On April 1, 2019, FDA 
published  a final rule to classify posterior cervical screw systems into class II (special 
controls) (84 FR 12088).1 
 
III.  Classification of Posterior Cervical Screw Systems 
A.  Classification Regulation  
The classification  regulation  for posterior cervical screw systems is 21 CFR 888.3075.2 The 
regulation  classifies posterior cervical screw systems (product code NKG) into class II 
(special controls).      
 
B.  Identification  of Posterior Cervical Screw Systems  
Paragraph (a) of 888.3075 identifies posterior cervical screw systems.    
 
C.  Posterior Cervical Screw Systems Class and Special 
Controls  
Paragraph (b) of 888.3075 establishes the class and special controls for posterior cervical 
screw systems.   
 
While posterior cervical screw systems3 must comply with the special controls,4 it is not 
expected that manufacturers of devices already on the market as of May 1, 2019, would need 
to submit new 510(k)s, 510(k) amendments, or add-to-files to demonstrate conformance with 
the special controls.5   
 
D.  Posterior Cervical Screw System Classification 
Regulation Effective Date 
The classification  rule became effective May 1, 2019.   
                                              
1 Available at https://www.regulations.gov/document?D=FDA-2015-N-3785-0009. 
2 https://gov.ecfr.io/cgi-
bin/retrieveECFR?gp=1&SID=068f27da33775aedfe34920c57076d02&ty=HTML&h=L&mc=true&r=SECTIO
N&n=se21.8.888_13075  
3 As identified in 21 CFR 888.3075(a) 
4 Section 513(a)(1)(B) of the FD&C Act, 21 U.S.C. 360c(a)(1)(B) 
5 84 FR 12088 at 12090, April 1, 2019 
2  Contains Nonbinding Recommendations 
 
E.  Viewing the Posterior Cervical Screw System 
Classification Regulation  
The United States government provides an electronic version of the Code of Federal 
Regulations (eCFR). The posterior cervical screw system regulation  can be found in the 
eCFR.6  The title number is 21. The section heading is 888.3075.   
 
                                              
6 https://gov.ecfr.io/cgi-bin/ECFR?SID=faf9398779e536bc9e7700b3cbc2ed79&mc=true&page=simple  
3