When intended to promote fusion of the cervical spine and occipitocervical junction (occiput -T3), the plate/rod, rod, hook and screw (3.2mm cortex, 3.5mm and 4.0mm cancellous) components of the Synthes CerviFix System are indicated for the following:

DDD (neck pain of discogenic origin with degeneration of the disc as confirmed . by patient history and radiographic studies)
spondylolisthesis
spinal stenosis
fracture/dislocation .
atlanto axial fracture with instability
occipitocervical dislocation .
revision of previous cervical spine surgery
. tumors

When used to treat these cervical and occipitocervical conditions, these screws are limited to occipital fixation only.

Hooks and Rods

The rod and hook components are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.

Rods. Clamps and Screws

The rods, clamps and screws are intended to promote fusion following reduction of fracture/dislocation or trauma in the upper thoracic spine (T1-T3)

The use of these screws (3.5mm cancellous, 4.0mm cancellous, 4.0mm and 4.35 expansionhead) is limited to placement in T1 -T3 in treating thoracic conditions only. They are not intended to be placed in or treat conditions involving the cervical spine.

The CerviFix System can also be linked to the Synthes Universal Spinal System using the 3.5/6.0mm parallel connectors from that system.

Device Description

Synthes CerviFix System consists of rods, plate/rods, clamps and bone screws. The hooks, clamps, rods and plate/rods are composed of the titanium alloy Ti6Al7Nb (ASTM F1295). The screws are composed of commercially pure grade 4 Titanium (ASTM F67).

AI/ML Overview

This K990965 document is a 510(k) summary for the Synthes CerviFix System, a medical device for spinal fusion. It is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device.

Crucially, this document does not contain information about acceptance criteria or a study proving the device meets those criteria, as it is a summary for a 510(k) application, not a clinical trial report.

Based on the provided document, the following information is available or can be inferred:

A table of acceptance criteria and the reported device performance:
Not provided in this 510(k) summary. A 510(k) primarily focuses on demonstrating substantial equivalence to a predicate device, often through comparison of indications for use, technological characteristics, and performance data if available (e.g., mechanical testing for spinal implants). Specific clinical acceptance criteria and performance metrics from a study are typically not included in this type of summary unless they were used for a specific performance test demonstrating equivalence.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Not provided. This document explicitly states, "The Synthes CerviFix System is substantially equivalent to itself." This implies that the basis for equivalence is likely a modification or rebranding of an existing device, or perhaps a component within an existing system, rather than a de novo clinical study with a test set of human patients. For spinal implants, performance data often comes from mechanical testing, not human clinical trials for a 510(k).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
Not applicable, as no clinical test set for ground truth establishment is described.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable, as no clinical test set requiring adjudication is described.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This device is a mechanical spinal implant, not an AI-driven diagnostic or therapeutic tool for which an MRMC study would be relevant.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a mechanical spinal implant, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable, as no clinical study requiring a ground truth is described. For spinal implants, "ground truth" might refer to successful fusion rates observed in clinical use of similar devices, or adherence to biomechanical performance standards, but this document does not detail such studies.
The sample size for the training set:
Not applicable. This device is a mechanical spinal implant, not a machine learning model requiring a training set.
How the ground truth for the training set was established:
Not applicable.

In summary:

The provided K990965 document is a regulatory submission demonstrating substantial equivalence for a medical device (spinal implant). It is not a report of a study that establishes acceptance criteria through clinical performance or provides data on device performance against specific criteria, especially not in the context of diagnostic accuracy or AI. The focus is on the device's indications for use and its components, and its substantial equivalence to a predicate device (implicitly, itself, suggesting a modification or re-filing).

Summary

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K990965
1 of 1

Summary of Safety and Effectiveness Information [510(k) Summary]

SYNTHES (U.S.A.) 1690 Russell Road Paoli. PA 19301

(610) 647-9700 Contact: Jonathan Gilbert 6/10/99

Device: Synthes CerviFix System consists of rods, plate/rods, clamps and bone screws. The hooks, clamps, rods and plate/rods are composed of the titanium alloy Ti6Al7Nb (ASTM F1295). The screws are composed of commercially pure grade 4 Titanium (ASTM F67).

Indications for Use:

Hooks. Plate/Rods. Rods and Screws

When intended to promote fusion of the cervical spine and occipitocervical junction (occiput-T3), the plate/rod, rod, hook and screw (3.2mm cortical, 3.5mm and 4.0mm cancellous) components of the Synthes CerviFix System are indicated for the following:

DDD (neck pain of discogenic origin with degeneration of the disc as confirmed . by patient history and radiographic studies)
spondylolisthesis .
spinal stenosis ●
fracture/dislocation ●
atlantoaxial fracture with instability
occipitocervical dislocation ●
revision of previous cervical spine surgery .
tumors .

When used to treat these cervical and occipitocervical conditions, these screws are limited to occipital fixation only.

Hooks and Rods

The rod and hook components are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.

Rods. Clamps and Screws

The rods, clamps and screws are intended to promote fusion following reduction of fracture/dislocation or trauma in the upper thoracic spine (T1-T3)

The CerviFix System can also be linked to the Synthes Universal Spinal System using the 3.5mm/6.0mm parallel connectors from that system.

This system is provided non-sterile: moist heat sterilization is recommended. Based on the above, the Synthes CerviFix System is substantially equivalent to itself.

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Image /page/1/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features the department's symbol, which is a stylized representation of three human profiles facing right, arranged in a stacked formation. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL - 1 1999

Mr. Jonathan Gilbert Senior Regulatory Affairs Associate SYNTHES SPINE P.O. Box 0548 1690 Russell Road Paoli, Pennsylvania 19301

Re: K990965

Trade Name: Synthes CerviFix System Regulatory Class: II Product Code: KWP and MNI Dated: June 10, 1999 Received: June 15, 1999

Dear Mr. Gilbert:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Jonathan Gilbert

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

510(k) Number (if known): K990965

Device Name: Synthes CerviFix System

Indications for Use:

Hooks, Plate/Rods, Rods and Screws

DDD (neck pain of discogenic origin with degeneration of the disc as confirmed . by patient history and radiographic studies)
spondylolisthesis
� spinal stenosis
�
fracture/dislocation .
atlanto axial fracture with instability ●
occipitocervical dislocation .
revision of previous cervical spine surgery ●
. tumors

When used to treat these cervical and occipitocervical conditions, these screws are limited to occipital fixation only.

Hooks and Rods

The rod and hook components are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.

Rods. Clamps and Screws

The rods, clamps and screws are intended to promote fusion following reduction of fracture/dislocation or trauma in the upper thoracic spine (T1-T3)

The CerviFix System can also be linked to the Synthes Universal Spinal System using the 3.5/6.0mm parallel connectors from that system.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Prescription Use	X
(Per 21 CFR 801.109)

b
ision Sign-Off

RA-03 CerviFix System

Regulation Number and Section

§ 888.3050 Spinal interlaminal fixation orthosis.

(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.