SYNTHES SPINE CERVIFIX SYSTEM

K984377 · Synthes (Usa) · KWP · Jan 21, 1999 · Orthopedic

Device Facts

• Record ID: K984377
• Device Name: SYNTHES SPINE CERVIFIX SYSTEM
• Applicant: Synthes (Usa)
• Product Code: KWP · Orthopedic
• Decision Date: Jan 21, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The CerviFix System is intended to provide stabilization to promote fusion of the cervical spine and occipital-cervical junction (occiput – T3) for the following indications: - 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 - occipital-cervical dislocation - revision of previous cervical spine surgery - tumors The screws are limited to occipital fixation only. The CerviFix System can also be linked to the Synthes Posterior Universal Spine System using the 3.5/6.0mm parallel connectors from that system.

Device Story

Spinal stabilization system; components include rods, plate/rods, hooks, bone screws, set screws. Used for cervical spine and occipital-cervical junction fusion (Occiput-T3). Surgeon implants construct by cutting/bending rods/plates, inserting into hooks, and locking with set screws; occipital screws fix plate to occiput; hooks attach rod to cervical spine. Can link to Synthes Posterior Universal Spine System via parallel connectors. Provides mechanical stabilization to promote bone fusion. Used in surgical settings by orthopedic or neurosurgeons.

Clinical Evidence

Bench testing only. Mechanical testing performed in accordance with ASTM F1717 documented static and fatigue performance characteristics, demonstrating suitability for posterior occipitocervical and upper thoracic (Occiput-T3) fixation.

Technological Characteristics

Materials: Titanium alloy TiAlNb (ASTM F1295) for rods/plates/hooks; commercially pure grade 4 Titanium (ASTM F67) for bone screws. Components: 3.5mm diameter rods, plate/rod constructs, hooks, set screws. Connectivity: Mechanical linkage to Universal Spine System via 3.5/6.0mm parallel connectors. Testing: ASTM F1717 static and fatigue.

Indications for Use

Indicated for patients requiring stabilization to promote fusion of the cervical spine and occipital-cervical junction (occiput to T3) due to DDD, spondylolisthesis, spinal stenosis, fracture/dislocation, atlanto-axial fracture with instability, occipital-cervical dislocation, revision surgery, or tumors.

Regulatory Classification

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.

Reference Devices

• Synthes Posterior Universal Spine System

Submission Summary (Full Text)

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510(k) Premarket Notification K984377 - Synthes CerviFix System - Additional Information

K984377

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

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

[phone] Contact: Jonathan Gilbert 01/08/99

Device: SYNTHES Spine CerviFix System consisting of rods, plate/rods, hooks, bone screws, parallel connectors and set screws. These components are manufactured from the titanium alloy TiAlNb (ASTM F1295). The bone screws are composed of commercially pure grade 4 Titanium (ASTM F67).

The CerviFix System is intended to provide stabilization to promote fusion of the cervical spine and occipital-cervical junction (occiput - T3) for the following indications:

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

The screws are limited to occipital fixation only.

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

The rods are 3.5mm in diameter and are offered in four lengths, 80, 120, 240 and 300mm. The plate/rod is a 3.5 mm or 6.0 mm diameter rod that transitions into a 3.5mm reconstruction plate at the opposite end. Hooks are available in both a left and right configuration to allow bilateral placement of the hook/rod or plate/rod/hook construct. The occipital bone screws are provided in the following configurations: a 3.2mm cortex screw, a 3.5mm cancellous screw, or a 4.0mm cancellous screw.

The device functions as follows: For non occipitocervical fusion, the end of the rod, cut to an appropriate length, is inserted into the rod opening of the hooks and loosely tightened into position with the set screws included in the hooks. The construct is then positioned under the laminae of the spinal seaments to be instrumented. Once the construct is compressed together, the set screws are locked down to the rod. For occipitocervical fusion, the plate/rod is bent and cut to an appropriate length. The plate portion of the implant is fixed to the occiput with screws and the rod portion is attached to the cervical spine with hooks. Hooks are available in both right and left opening configurations to allow bilateral placement of the hook/rod construct.

The construct can also be linked to the 6.0mm diameter rods of the Universal Spine System (USS) using 3.5mm/6.0mm parallel connectors.

Mechanical testing was previously performed in accordance with ASTM standard F1717. This testing documented both static and fatigue performance characteristics and demonstrated that the performance characteristics satisfy the requirements of posterior occipitocervical and upper thoracic (Occiput-T3) fixation.

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Material composition is identical to numerous other Synthes Spinal products that have been meand via the 510(k) process. The methods for use and instrumentation to implant this system is similar to that of the Synthes CerviFix and the Occipital-Cervical Plate/Rod and Hook systems.

Based on the above, the Synthes Spine CerviFix System is substantially equivalent to components cleared in previously cleared Synthes premarket submissions.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of a human figure with its head tilted back, and its arms outstretched. The figure is surrounded by a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. The text is written in all capital letters.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 1 1999

Mr. Jonathan M. Gilbert Senior Regulatory Affairs Associate Synthes Spine Post Office Box 0548 1690 Russell Road Paoli, Pennsylvania 19301

Re: K984377

> Synthes CerviFix System - additional components Regulatory Class: II Product Code: KWP Dated: December 2, 1998 Received: December 3, 1998

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 legally marketed predicate 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 requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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 M. 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 vour 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/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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## 510(k) Premarket Notification K984377 - Synthes CerviFix System - Additional Information

Page 1 of 1

510(k) Number (if known): NA K984377

Device Name: Synthes CerviFix System

Indications for Use:

The CerviFix System is intended to provide stabilization to promote fusion of the cervical spine and occipital-cervical junction (occiput – T3) for the following indications:

- 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 .
- occipital-cervical dislocation .
- revision of previous cervical spine surgery .
- . tumors

The screws are limited to occipital fixation only.

The CerviFix System can also be linked to the Synthes Posterior Universal Spine 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)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Over-the-Counter Use ____________(Per 21 CFR 801.109) OR Prescription Use

Piccolo

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number. 198437