SYNTHES ANTERIOR TENSION BAND (ATB) SYSTEM

K022791 · Synthes (Usa) · KWQ · Nov 13, 2002 · Orthopedic

Device Facts

• Record ID: K022791
• Device Name: SYNTHES ANTERIOR TENSION BAND (ATB) SYSTEM
• Applicant: Synthes (Usa)
• Product Code: KWQ · Orthopedic
• Decision Date: Nov 13, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Synthes Anterior Tension Band System is indicated for use via the lateral or anterolateral surgical approach above the bifurcation of the great vessels or via the anterior surgical approach, below the bifurcation of the great vessels. This system is indicated in the treatment of lumbar and lumbosacral (L1 - S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), pseudoarthrosis, spondylolysis, spondylolisthesis, scoliosis, lordotic deformities of the spine, spinal stenosis, or a failed previous spine surgery.

Device Story

Synthes Anterior Tension Band (ATB) System consists of titanium alloy plates and 5.5 mm locking cancellous screws; designed for anterior or anterolateral fixation of lumbar/lumbosacral spine (L1-S1). Device provides mechanical stabilization to facilitate biological spinal fusion. Used by surgeons in clinical/OR settings; implanted to address spinal instability from various pathologies including fractures, tumors, and degenerative conditions. Output is physical stabilization of vertebral segments; clinical benefit is support for fusion process and correction of spinal alignment.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Titanium alloy plates and 5.5 mm cancellous screws with locking heads. Mechanical fixation system for spinal stabilization. No software or electronic components.

Indications for Use

Indicated for patients requiring stabilization of lumbar and lumbosacral (L1-S1) spine instability due to fracture, tumor, degenerative disc disease, pseudoarthrosis, spondylolysis, spondylolisthesis, scoliosis, lordotic deformities, spinal stenosis, or failed previous surgery. Used via lateral, anterolateral, or anterior surgical approaches.

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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# KO22791 PAGE 1/1

# NOV 1 3 2002

Synthes Spine 510(k) Premarket Notification Anterior Tension Band (ATB) System

#### 11.0 510(K) SUMMARY

#### DESCRIPTION

The Synthes Anterior Tension Band System consists of a range of plate sizes and 5.5 mm cancellous screws with a locking head. The plates attach to the anterior or anterolateral aspect of the vertebral body of the lumbar / lumbosacral spine (levels L1-S1) and provide stabilization to permit the biological process of spinal fusion to occur. All components are manufactured from Titanium alloy.

### INDICATIONS

The Synthes Anterior Tension Band System is indicated for use via the lateral or anterolateral surgical approach above the bifurcation of the great vessels or via the anterior surgical approach, below the bifurcation of the great vessels. This system is indicated in the treatment of lumbar and lumbosacral (L1 - S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), pseudoarthrosis, spondylolysis, spondylolisthesis, scoliosis, lordotic deformities of the spine, spinal stenosis, or a failed previous spine surgery.

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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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, rendered in a simple, bold line drawing.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 13 2002

Vikki M. Hoffman Senior RA Associate Synthes Spine 1690 Russell Road Paoli, Pennsylvania 19301

Re:

K022791 Synthes Anterior Tension Band (ATB) System Trade Name: 21 CFR 888.3060 Regulation Number: Spinal Intervertebral Fixation Orthosis Regulation Name: Regulatory Class: Class II KWQ Product Code: Dated: August 20, 2002 August 22, 2002 Received:

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 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 -- Ms. Vikki M. Hoffman

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 and additionally 21 CFR Part 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 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/dsmamain.html.

Sincerely yours,

Sincerely, yours,

L. Mark N. Milikens

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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### Synthes Spine 510(k) Premarket Notification Anterior Tension Band (ATB) System

## 3.0 FDA INDICATIONS FOR USE FORM

510(k) Number (if known): K 022791

Device Name: Synthes Anterior Tension Band (ATB) System

# INDICATIONS FOR USE:

The Synthes Anterior Tension Band System is indicated for use via the lateral or anterolateral surgical approach above the bifurcation of the great vessels or via the anterior surgical approach, below the bifurcation of the great vessels. This system is indicated in the treatment of lumbar and lumbosacral (L1 - S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), pseudoarthrosis, spondylolysis, spondylolisthesis, scoliosis, lordotic deformities of the spine, spinal stenosis, or a failed previous spine surgery.

(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 H. Milliken

(Division Sign-Off) Division of General, Restorati and Neurological Devices

510(k) Number KC

CONFIDENTIAL