RIM-FIX, ACETABULAR CUP

K993713 · Surgical Implants, Inc. · JDI · Jan 28, 2000 · Orthopedic

Device Facts

• Record ID: K993713
• Device Name: RIM-FIX, ACETABULAR CUP
• Applicant: Surgical Implants, Inc.
• Product Code: JDI · Orthopedic
• Decision Date: Jan 28, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3350
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Rim-Fix, acetabular cup system is intended to be used as the pelvic component of a total hip arthroplasty. It can be implanted either as a press fit cup or cemented into the cavity. The acetabular cup is used to restore the acetabular cavity in a total joint arthroplasty and is used in conjunction with a metal femoral hip stem. The indications for use of the Rim-Fix cup system are as follows: Osteoarthritis, rheumatoid arthritis, posttraumatic arthritis or arthritis secondary to a variety of diseases or anomalies, or revision from a failed arthroplasty.

Device Story

Rim-Fix Acetabular Cup System functions as the pelvic component in total hip arthroplasty; implanted via press-fit or cementation into the acetabular cavity; used in conjunction with metal femoral hip stems. Device restores acetabular cavity anatomy. Intended for surgical use by orthopedic surgeons in clinical settings. Output is a physical implant providing structural support for hip joint articulation; facilitates patient mobility and pain reduction.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on device description and intended use.

Technological Characteristics

Acetabular cup for total hip arthroplasty; designed for press-fit or cemented fixation. Physical form factor is a cup component. No software, electronics, or energy sources involved.

Indications for Use

Indicated for patients requiring total hip arthroplasty due to osteoarthritis, rheumatoid arthritis, posttraumatic arthritis, arthritis secondary to diseases/anomalies, or revision of failed arthroplasty.

Regulatory Classification

Identification

A hip joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JAN 2 8 2000

Mr. Douglas W. Stuart President Surgical Implants, Inc. 962 South Tamiami Trail Suite 203 Sarasota, Florida 34326

Re: K993713

> Trade Name: Rim-Fix, Acetabular Cup Regulatory Class: II Product Code: JDI Dated: October 20, 1999 Received: November 3, 1999

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. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) 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 regulation may result in regulatory 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.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed

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Page 2 - Mr. Douglas W. Stuart

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,

Russell J. Wagner

Su James E. Dillard III Acting 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

Unknown_ K993713 510(K) Number: __ Rim-Fix Acetabular Cup System Device Name:

Intended Use

Indicated Use:

The Rim-Fix, acetabular cup system is intended to be used as the pelvic component of a total hip arthroplasty. It can be implanted either as a press fit cup or cemented into the cavity. The acetabular cup is used to restore the acetabular cavity in a total joint arthroplasty and is used in conjunction with a metal femoral hip stem. The indications for use of the Rim-Fix cup system are as follows: Osteoarthritis, rheumatoid arthritis, posttraumatic arthritis or arthritis secondary to a variety of diseases or anomalies, or revision from a failed arthroplasty.

| Signed: | Diostunt |
|---------|----------|
|---------|----------|

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

| | Concurrence of CDRH, Office of Device Evaluation (ODE) | | |
|----------------------------------------------------------------|--------------------------------------------------------|--------------------------|--|
| | | | |
| (Division Sign-Off)<br>Division of General Restorative Devices | | | |
| 510(k) Number K99 3717 | | | |
| Prescription Use ✓ | OR | Over The Counter Use __ | |
| (Per 21 CFR 801.109) | | (Optional Format 1-2-96) | |