SYNTHES CONTOURED SYNMESH SPACER

K041389 · Synthes Spine · MQP · Oct 1, 2004 · Orthopedic

Device Facts

• Record ID: K041389
• Device Name: SYNTHES CONTOURED SYNMESH SPACER
• Applicant: Synthes Spine
• Product Code: MQP · Orthopedic
• Decision Date: Oct 1, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SYNTHES® Contoured SynMesh® Spacer is a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). The SYNTHES® Contoured SynMesh® Spacer is designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.

Device Story

The SYNTHES® Contoured SynMesh® Spacer is a titanium vertebral body replacement implant; used in the thoracolumbar spine (T1-L5) following corpectomy or vertebrectomy. The device provides anterior spinal column support for collapsed, damaged, or unstable vertebrae caused by tumor or trauma. It is intended for use in skeletally mature patients in conjunction with supplemental internal fixation systems (e.g., ATLP, Ventrofix, TSLP, USS). The spacer interior may be packed with bone graft. The device is designed to maintain structural stability even in the absence of fusion for a prolonged period.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Material: Commercially pure titanium. Form factor: Contoured vertebral body replacement spacer. Energy source: None (mechanical implant). Connectivity: None. Sterilization: Not specified. Software: None.

Indications for Use

Indicated for skeletally mature individuals requiring vertebral body replacement in the thoracolumbar spine (T1-L5) due to tumor or trauma (fracture). Must be used with supplemental internal fixation.

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® SynMesh® Spacer System (K003275)

Reference Devices

• ATLP
• Ventrofix
• TSLP
• USS
• Dual Opening USS
• Small Stature USS
• Click'X

Submission Summary (Full Text)

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K041389

3.0 Premarket Notification 510 (k) Summary OCT 1 - 2004

| Date Prepared: | May 21, 2004 |
|--------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sponsor Information:<br>Name and Address: | SYNTHES® Spine.<br>1230 Wilson Drive<br>West Chester, PA 19380 |
| Telephone: | [phone] |
| Contact Person: | Angela Mikroulis |
| Device Name:<br>Trade or Proprietary Name: | SYNTHES® Contoured SynMesh® Spacer |
| Common Name: | Implant, fixation, spinal intervertebral body<br>fixation orthosis device. |
| Classification Name/Class: | Per 21 CFR 888.3060: Spinal intervertebral<br>body fixation orthosis, Class II. |
| Device Description: | The SYNTHES® Contoured SynMesh® Spacer<br>is a titanium vertebral body replacement device<br>used in conjunction with supplemental internal<br>fixation to provide structural stability in<br>skeletally mature individuals following<br>corpectomy / vertebrectomy. |
| Predicate Device (s): | SYNTHES® SynMesh® Spacer System<br>(K003275) |
| Intended Use: | The SYNTHES® Contoured SynMesh® Spacer<br>is a vertebral body replacement device intended<br>for use in the thoracolumbar spine (T1-L5) to<br>replace a collapsed, damaged, or unstable<br>vertebral body due to tumor or trauma (i.e.,<br>fracture). The SYNTHES® Contoured<br>SynMesh® Spacer is designed to provide<br>anterior spinal column support even in the<br>absence of fusion for a prolonged period. |
| Material: | Commercially pure titanium |
| Substantial Equivalence: | Documentation is provided which demonstrates<br>that the SYNTHES® Contoured SynMesh®<br>Spacer for Spinal intervertebral body fixation<br>orthosis is Substantially Equivalent to other<br>legally marketed SYNTHES® devices. |

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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" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or a stylized human figure with outstretched arms.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 - 2004

Ms. Angela Mikroulis Regulatory Affairs Specialist Synthes Spine 1230 Wilson Drive West Chester, Pennsylvania 19380

Re: K041389

Trade/Device Name: SYNTHES® Contoured SynMesh® Spacer Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MQP Dated: September 1, 2004 Received: September 3, 2004

Dear Ms. Mikroulis:

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. Angela Mikroulis

This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to ocgin marketing your arrivalence of your device to a legally premarket notheation. The PDA miang of basification 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 specific advice for your as 10-1) 276-0120. Also, please note the regulation entitled, Colliation of Compullios as (210) = 17 = 17 = 15 = 1 = 1 807.97). You may obtain Misblanding of reference to premail.orgibilities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number [phone] or 1011) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours,

Mark N Millman

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® Special 510 (k): Device Modification / Line Extension SYNTHES® SynMesh Spacer System-(K003275)

2.0 Indications for Use Statement

રિભ જિલ્લ 510(k) Number (if known):

Device Name: SYNTHES® Contoured SynMesh® Spacer

Indications for Use: SYNTHES® Contoured SynMesh® Spacer is a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e. fracture). The SYNTHES® Contoured SynMesh® Spacer is intended to be used with SYNTHES® supplemental internal fixation systems, e.g., ATLP, Ventrofix, TSLP, and USS, Dual Opening USS, Small Stature USS, and Click'X. The interior of the spacer component of the SYNTHES® SynMesh® Spacer can be packed with bone.

SYNTHES® Contoured SynMesh® Spacer is designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.

Prescription Use______________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C)

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

Mark N. Milken

Division of General, Restorative, and Neurological Devices

**510(k) Number** K041389

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