SYNTHES VENTROFIX MIS SYSTEM

K031100 · Synthes (Usa) · KWQ · Mar 4, 2004 · Orthopedic

Device Facts

• Record ID: K031100
• Device Name: SYNTHES VENTROFIX MIS SYSTEM
• Applicant: Synthes (Usa)
• Product Code: KWQ · Orthopedic
• Decision Date: Mar 4, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Synthes VentroFix MIS System is indicated for use, via the lateral or anterolateral surgical approach, in the treatment of thoracic and thoracolumbar (T1-L5) spine instability as a result of degenerative disc disease (defined as pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), spondylolisthesis, spondylolysis, fracture (including dislocation and subluxation), spinal stenosis, deformities (i.e., scoliosis, kyphosis, lordosis whether neuromuscular or related to deficient posterior elements), tumors (neoplastic disease), pseudoarthrosis, or a failed previous fusion.

Device Story

The Synthes VentroFix MIS System is a spinal fixation orthosis consisting of titanium alloy plates and screws. It is designed for attachment to the anterolateral aspect of the vertebral bodies in the thoracic and thoracolumbar spine (T1-L5). The device provides stabilization to the spine to facilitate spinal fusion. It is intended for use by surgeons in an operating room setting. The system is implanted via lateral or anterolateral surgical approaches to address various spinal pathologies, including degenerative disc disease, fractures, and deformities. By providing mechanical stabilization, the device supports the fusion process, potentially reducing pain and correcting spinal alignment for the patient.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design and material characteristics.

Technological Characteristics

System consists of titanium alloy plates and screws for anterolateral vertebral body fixation. Designed for T1-L5 levels. Mechanical stabilization device.

Indications for Use

Indicated for patients with thoracic and thoracolumbar (T1-L5) spine instability due to degenerative disc disease, spondylolisthesis, spondylolysis, fracture, spinal stenosis, deformities (scoliosis, kyphosis, lordosis), tumors, pseudoarthrosis, or failed previous fusion. Used via lateral or anterolateral surgical approach.

Regulatory Classification

Identification

A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.

Submission Summary (Full Text)

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MAR - 4 2004

K031100
page 1 of 1

### 11.0 510(K) SUMMARY

### DESCRIPTION

DEOOKIP TION
The Synthes VentroFix MIS System consists of a range of plate sizes and 7.0 The Synthos Ventrol IX MiD Cyttach to the anterolateral aspect of the vertebral min bono of the thoracolumbar spine (levels T1-L5) and provide stabilization to body of the thoradoal process of spinal fusion to occur. All components are manufactured from Titanium alloy.

#### INDICATIONS

The Synthes VentroFix MIS System is indicated for use, via the lateral or The Oynthous vontrol approach, in the treatment of thoracic and thoracolumbar anterer surgroundsproading it of degenerative disc disease (defined as pain ( 1 - 2) spiric including as a reeration of the disc confirmed by patient history or diographic studies), spondylolisthesis, spondylolysis, fracture (including dislocation and subluxation), spinal stenosis, deformities (i.e., scoliosis, kyphosis, lordosis whether neuromuscular or related to deficient posterior elements), tumors (neoplastic disease), pseudoarthrosis, or a failed previous fusion.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR - 4 2004

Susan Lewandowski Project Manager, Regulatory Affairs Synthes (USA) 1380 Enterprise Drive West Chester, Pensylvania 19380

Re: K031100

Trade/Device Name: Synthes VentroFix MIS System Regulatory Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWQ Dated: December 29, 2003 Received: December 30, 2003

Dear Ms. Lewandowski:

We have reviewed your Scction 510(k) premarket notification of intent to market the device we nave roviewed your over determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the exerce . 1976, the cnactment 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 r ou may, arover or visions 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 Rogister.

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 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.

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Page 2 - Susan Lewandowski

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis loter will and noy of substantial equivalence of your device of your device to a legally prematics notification." The 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 If you desire of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general 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,

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

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## 3.0 INDICATIONS FOR USE FORM

510(k) Number (if known):K 1031100

Synthes VentroFix MIS System Device Name:

# INDICATIONS FOR USE:

The Synthes VentroFix MIS System is indicated for use, via the lateral or The Synthes Ventrol ix MIO Oyotan to matchent of thoracic and thoracolumbar anterolateral surgical approach, in the treatmentive disc disease (defined as pain
(T1-L5) spine instability as a result of degenerative disc disease (defined as pain (11-L5) spire instablility as a result of the disc confirmed by patient history of discogenic ongin with degendration of the spondylolysis, fracture (including
and radiographic studies), spondylolisthesis, spondylolises dislocation and subluxation), spinal stenosis, deformities (i.e., scollosis, dislocation and Sublaxation), Spinal Station or related to deficient posterior kyphosis, lordosis whether nouromasoural arease), pseudoarthrosis, or a failed previous fusion.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _x (Per 21 CFR § 801.109)

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ OR

signature

(Division Sign-Off Division of General, Restorative, and Neurological Devices

510(k) Number L031102