MODIFICATION TO SYNTHES CERVIFIX SYSTEM

K030377 · Synthes (Usa) · MNI · Mar 6, 2003 · Orthopedic

Device Facts

• Record ID: K030377
• Device Name: MODIFICATION TO SYNTHES CERVIFIX SYSTEM
• Applicant: Synthes (Usa)
• Product Code: MNI · Orthopedic
• Decision Date: Mar 6, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The CerviFix® System is 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, Screws and Nuts: The rods, clamps, screws and nuts are intended to promote fusion following reduction of fracture/dislocation or trauma in the upper thoracic spine (T1-T3). The use of these screws (3.5 mm, 4.0 mm cancellous and 3.5 mm, 4.2 mm cortex) 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 Synthes CerviFix™ System can also be linked to the Synthes Universal Spinal System using the 3.5 mm/6.0 mm parallel connectors from that system. and via the CerviFix tapered rods using lamina hooks, transverse process hooks, pedicle hooks, 4.2 mm screws, and the 5.0 mm/ 6.0 mm parallel connector.

Device Story

Synthes CerviFix System is a spinal fixation implant set comprising rods, plates, hooks, clamps, screws, nuts, transconnectors, and transverse bars. Designed for surgical stabilization and fusion of cervical and upper thoracic (C1-T3) spine. Implants are manufactured from titanium or stainless steel. System components are used by surgeons in an operating room setting to provide structural support following trauma, fracture, dislocation, or degenerative conditions. The system allows for modular assembly and can be linked to the Synthes Universal Spinal System via parallel connectors and tapered rods. The device provides mechanical stabilization to promote bone fusion, thereby addressing spinal instability and alleviating associated pain or neurological symptoms.

Clinical Evidence

bench testing only

Technological Characteristics

Materials: Titanium or Stainless Steel. Components: Rods, plates, hooks, clamps, screws, nuts, transconnectors, transverse bars. Form factor: Modular spinal fixation system. Connectivity: Mechanical linkage to Synthes Universal Spinal System via parallel connectors. Energy source: None (mechanical).

Indications for Use

Indicated for patients with cervical/upper thoracic (C1-T3) conditions including DDD, spondylolisthesis, spinal stenosis, fracture/dislocation, atlantoaxial fracture with instability, occipitocervical dislocation, revision of previous cervical spine surgery, and tumors. Screws are restricted to occipital fixation for cervical/occipitocervical conditions and T1-T3 placement for thoracic conditions.

Regulatory Classification

Identification

(1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.

Special Controls

*Classification.* (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards; (ii) Compliance with mechanical testing standards; (iii) Compliance with biocompatibility standards; and (iv) Labeling that contains these two statements in addition to other appropriate labeling information: “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 neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.” “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.” (2) Class II (special controls), when a rigid pedicle screw system is 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. These pedicle screw systems must comply with the following special controls: (i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use. (ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant. (iii) Device components must be demonstrated to be biocompatible. (iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments. (v) Labeling must include the following: (A) A clear description of the technological features of the device including identification of device materials and the principles of device operation; (B) Intended use and indications for use, including levels of fixation; (C) Identification of magnetic resonance (MR) compatibility status; (D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and (E) Detailed instructions of each surgical step, including device removal. (3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls: (i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate. (ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.

Reference Devices

• Synthes Universal Spinal System

Submission Summary (Full Text)

{0}------------------------------------------------

# K030377 PV

# 8.4.1 ATTACHMENT IV -- 510K SUMMARY OF SAFETY AND EFFECTIVENESS DEVICE

MAR 0 6 2003

Synthes CerviFix® consists of rods, plate/rods, hooks, clamps, screws, nuts, transconnectors and transverse bars. The implants are composed of Titanium or Stainless Steel.

# INDICATIONS

Indications for Use:

The CerviFix® System is 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, Screws and Nuts

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

The use of these screws (3.5 mm, 4.0 mm cancellous and 3.5 mm, 4.2 mm cortex) is limited to placement in T1-T3 in treating thoracic conditions only. Thev are not intended to be placed in or treat conditions involving the cervical spine.

The Synthes CerviFix™ System can also be linked to the Synthes Universal Spinal System using the 3.5 mm/6.0 mm parallel connectors from that system. and via the CerviFix tapered rods using lamina hooks, transverse process hooks, pedicle hooks, 4.2 mm screws, and the 5.0 mm/ 6.0 mm parallel connector.

{1}------------------------------------------------

Image /page/1/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 an eagle in flight. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# MAR 0 6 2003

Ms. Vikki Hoffman Senior Regulatory Affairs Associate Synthes Spine Post Office Box 0548 1690 Russell Road Paoli, Pennsylvania 19301

Re: K030377

> Trade/Device Name: Synthes CerviFix™ System Regulatory Number: 21 CFR 888.3070, 21 CFR 888.3050 Regulation Name: Pedicle screw spinal system, Spinal interlaminal fixation orthosis Regulatory Class: II Product Code: MNI, KWP Dated: February 4, 2003 Received: February 5, 2003

Dear Ms. Hoffman:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set

{2}------------------------------------------------

Page 2 - Ms. Vikki Hoffman

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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), 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark H. Millerson

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

Enclosure

{3}------------------------------------------------

page 1 of 2

#### ATTACHMENT II - INDICATIONS FOR USE STATEMENT 8.2

510(k) Number (if known):_K(3303777

Device Name: Synthes CerviFix®

Indications for Use:

The CerviFix® System is 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, Screws and Nuts

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

The use of these screws (3.5 mm, 4.0 mm cancellous and 3.5 mm, 4.2 mm cortex) 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.

for Mark N. Milkerer

Division of

Neuro

510(k) Nu... K030371

{4}------------------------------------------------

Q3a377

page sofa

The Synthes CerviFix™ System can also be linked to the Synthes Universal Spinal System using the 3.5 mm/6.0 mm parallel connectors from that system. and via the CerviFix tapered rods using lamina hooks, transverse process hooks, pedicle hooks, 4.2 mm screws, and the 5.0 mm/ 6.0 mm parallel connector.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR § 801.109) OR Over-The-Counter Use

Mark N Milliken

Divis in Distston ano Neut 10(k) N

K030377