LINK, ACETABULAR REVISION MESH CUP

K972760 · Link America, Inc. · JDJ · Oct 22, 1997 · General, Plastic Surgery

Device Facts

• Record ID: K972760
• Device Name: LINK, ACETABULAR REVISION MESH CUP
• Applicant: Link America, Inc.
• Product Code: JDJ · General, Plastic Surgery
• Decision Date: Oct 22, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Cases of acetabular erosion or protrusio are not un-common. These problems are usually caused by a prior, failed acetabular implant, or a trauma induced fracture, or as a result of progressive joint disease. The surgical re-construction of the acetabular it is necessary to restore the floor or defect in the natural acetabular joint cavity. Using the mesh cup or mesh sheet as a scaffold. This creates a sound foundation or base for the definitive load bearing acetabular cup replacement devise:

Device Story

Device consists of acetabular mesh cup and mesh sheet; used as surgical scaffold/foundation during acetabular reconstruction. Input: surgical site defect (erosion, protrusio, fracture, or failed implant). Operation: mesh acts as structural support/base for definitive load-bearing acetabular cup replacement. Used in OR by orthopedic surgeons. Benefit: restores acetabular floor integrity; facilitates stable placement of primary load-bearing implant.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Acetabular mesh cup and sheet; metallic mesh scaffold; intended for implantation. No specific materials, dimensions, or software characteristics provided in the document.

Indications for Use

Indicated for patients requiring surgical reconstruction of the acetabular joint cavity due to acetabular erosion, protrusio, prior failed acetabular implant, trauma-induced fracture, or progressive joint disease. Used as a scaffold to restore the floor or defect in the natural acetabular joint cavity to provide a foundation for a definitive load-bearing acetabular cup replacement.

Regulatory Classification

Identification

Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 2 1997

Mr. Douglas W. Stuart Surqical Implants Incorporated for Link America, Inc. 962 South Tamiami Trail, Ste. 203 Sarasota, Florida 34326

Re: K972760 Acetabular Revision Mesh and Cup Trade Name: Regulatory Class: II Product Code: JDJ Dated: July 16, 1997 and the comments of the comments of Received: July 24, 1997

Dear Mr. Stuart:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. ਸੇ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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### Page 2 - Mr. Douglas W. Stuart

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA association 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 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from-the Division of Small Manufacturers Assistance " at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

a M. Witten, Ph.D., M.D. 1Cell Director

Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Exhibit 8

# STATEMENT OF INTENDED USE

#### not known 510(K) Number Device Name: Link Acetabular Mesh Cup and Sheet

### Indications For Use:

## Statement of Intended Use

Cases of acetabular erosion or protrusio are not un-common. These problems are usually caused by a prior, failed acetabular implant, or a trauma induced fracture, or as a result of progressive joint disease. The surgical re-construction of the acetabular it is necessary to restore the floor or defect in the natural acetabular joint cavity. Using the mesh cup or mesh sheet as a scaffold. This creates a sound foundation or base for the definitive load bearing acetabular cup replacement devise: ---------------------------

**Signed:** DW Stuart

(Please do not write below this line - continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) | |
|-----------------------------------------|--|
| Division of General Restorative Devices | |

| 510(k) Number | K972760 |
|---------------|---------|
|---------------|---------|

| Prescription Use | X | OR | Over The Counter Use | _ |
|----------------------|---|----|----------------------|--------------------------|
| (Per 21 CFR 801.109) | | | | (Optional Format 1-2-96) |