ARCOFIX

K080020 · Synthes Spine Co.Lp · KWQ · May 23, 2008 · Orthopedic

Device Facts

• Record ID: K080020
• Device Name: ARCOFIX
• Applicant: Synthes Spine Co.Lp
• Product Code: KWQ · Orthopedic
• Decision Date: May 23, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Synthes ArcoFix 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 the following: • Degenerative Disc Disease (defined as back 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 • Failed previous fusion.

Device Story

Synthes ArcoFix System is an expandable plate and bone screw fixation system for thoracic and thoracolumbar spine stabilization. Used via lateral or anterolateral surgical approach. Implanted by surgeons to provide structural support and fixation for spinal instability. Device components are manufactured from Titanium Aluminum Niobium (Ti-6Al-7Nb). System is an addition to existing anterior/anterolateral/lateral thoracolumbar spine systems.

Clinical Evidence

Bench testing only; no clinical data was required or provided for this device.

Technological Characteristics

Materials: Titanium Aluminum Niobium (Ti-6Al-7Nb) per ASTM F1295. Components: Expandable plate and 4 bone screws. Application: Spinal intervertebral body fixation. Energy source: None (mechanical).

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.

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.

Predicate Devices

• Synthes VentroFix MIS (K031100)
• Synthes Anterior Tension Band (ATB) System (K022791)

Submission Summary (Full Text)

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K080020

## @ SYNTHES* Spine

MAY 2 3 2008

## 5 510(k) Summary

| 510(k) Summary | | |
|-------------------|---------------------------------------------------------------------------------|--|
| Name of Firm: | Synthes Spine | |
| | 1302 Wrights Lane East | |
| | West Chester, PA 19380 | |
| 510(k) Contact: | Kirsten Stowell | |
| | Associate Regulatory Affairs Specialist | |
| | Telephone: [phone]<br>Facsimile: 610-719-5102 | |
| | Email: [e-mail] | |
| Date Prepared: | January 2, 2008 | |
| Trade Name: | Synthes ArcoFix System | |
| Classification: | 21 CFR 888.3060 - Spinal Intervertebral Body Fixation Orthosis | |
| | Class II | |
| | Orthopaedic and Rehabilitation Devices Panel | |
| | Product Code: KWQ | |
| Predicates: | Synthes VentroFix MIS (K031100) | |
| | Synthes Anterior Tension Band (ATB) System (K022791) | |
| Device | The Synthes ArcoFix System is an addition to Synthes' existing | |
| Description: | anterior/anterolateral/lateral thoracolumbar spine systems. The ArcoFix implant | |
| | consists of an expandable plate and 4 bone screws, all manufactured from | |
| | Titanium Aluminum Niobium (Ti-6Al-7Nb) ASTM F1295, the same as the | |
| | predicates. | |
| Intended Use/ | Synthes ArcoFix System is indicated for use, via the lateral or anterolateral | |
| Indications for | surgical approach, in the treatment of thoracic and thoracolumbar (T1-L5) spine | |
| Use: | instability as a result of the following: | |
| | • Degenerative Disc Disease (defined as back 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 | |
| | • Failed previous fusion. | |
| Comparison of | The Synthes ArcoFix System is a result of design modifications to the predicate | |
| the device to | devices. It is substantially equivalent to the predicates in design, function, | |
| predicate | material, and intended use. | |
| device(s): | | |
| Performance | Non-Clinical Performance and Conclusions: | |
| Date | Bench testing results demonstrate that the Synthes ArcoFix System is | |
| (Non-Clinical | substantially equivalent to the predicate devices. | |
| and/or Clinical): | Clinical Performance and Conclusions: | |
| | Clinical data and conclusions were not needed for this device. | |

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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 features a stylized eagle with three stripes forming its wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 3 2008

Synthes Spine CO. LP % Ms. Kirsten Stowell Associate Regulatory Affairs Specialist 1302 Wrights Lane East West Chester, Pennsylvania 19380

Re: K080020/S002

> Trade/Device Name: Synthes ArcoFix System Regulation Number: 21 CFR 888.3060 Regulation Names: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWQ Dated: May 15, 2008 Received: May 19, 2008

Dear Ms. Stowell:

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. Kirsten Stowell

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number [phone] or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark M. Wilkerson

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/3/Picture/0 description: The image shows the logo for Synthes Spine. The logo consists of the Synthes symbol on the left, followed by the word "SYNTHES" in bold, sans-serif font. Below the word "SYNTHES" is the word "Spine" in a smaller, italicized font.

4 Indications for Use Statement

510(k) Number: (if known)

K 080020

Device Name: Synthes ArcoFix System

Indications for Use:

The Synthes ArcoFix 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 the following:

- Degenerative Disc Disease (defined as back 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 ●
- Failed previous fusion. .

Prescription Use X (21 CFR 801 Subpart D) AND / OR

Over-the-Counter Use (21 CFR 801 Subpart C)

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

CONFIDENTIAL
Traditional 510(k) - Synthes ArcoFix System
Concurrence of CDRH, Office of Device Evaluation (ODE)

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

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| 510(k) Number | K080020 |
|---------------|---------|
|---------------|---------|

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