BUECHEL-PAPPAS HUMERAL HEAD RESURFACING COMPONENT

K992394 · Endotec, Inc. · HSD · Oct 15, 1999 · Orthopedic

Device Facts

• Record ID: K992394
• Device Name: BUECHEL-PAPPAS HUMERAL HEAD RESURFACING COMPONENT
• Applicant: Endotec, Inc.
• Product Code: HSD · Orthopedic
• Decision Date: Oct 15, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The BUECHEL-PAPPAS™ Humeral Head Resurfacing Shoulder Component is intended for the reconstruction of painful and/or severely disabled shoulder joints resulting from osteoarthritis and rheumatoid arthritis. For proper function of this device, the humeral head and neck must be of sufficient bone stock to support the loads on it. Also, the presence of an intact or reconstructable rotator cuff is important for proper functioning and dislocation resistance. Biocoat® porous coated components are intended for cemented use only.

Device Story

The Buechel-Pappas™ Humeral Head Resurfacing Component is a prosthetic implant used in shoulder arthroplasty. It replaces the damaged humeral head surface to restore joint function in patients with osteoarthritis or rheumatoid arthritis. The device is surgically implanted by an orthopedic surgeon in an operating room setting. It requires adequate bone stock and a functional rotator cuff for stability and load-bearing. Biocoat® porous coated versions are designed for cemented fixation. By resurfacing the joint, the device aims to reduce pain and improve mobility for the patient.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Humeral head resurfacing implant; includes Biocoat® porous coated components for cemented use. Requires sufficient bone stock and intact rotator cuff for mechanical stability.

Indications for Use

Indicated for reconstruction of painful/severely disabled shoulder joints due to osteoarthritis or rheumatoid arthritis. Requires sufficient humeral head/neck bone stock and intact/reconstructable rotator cuff. Contraindicated for post-traumatic arthritis, rotator cuff dysfunction, humeral head avascular necrosis, failed previous prosthesis, or congenital dysplasia.

Regulatory Classification

Identification

A shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis is a device made of alloys, such as cobalt-chromium-molybdenum. It has an intramedullary stem and is intended to be implanted to replace the articular surface of the proximal end of the humerus and to be fixed without bone cement (§ 888.3027). This device is not intended for biological fixation.

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular design with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle with three lines representing its wings and a wavy line representing its body.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 5 1999

Mr. John Pappas Regulatory Affairs Endotec 20 Valley Street South Orange, New Jersey 07079

Re: K992394

> Trade Name: Buechel-Pappas™ Humeral Head Resurfacing Component Regulatory Class: II Product Code: HSD Dated: July 16, 1999 Received: July 19, 1999

Dear Mr. Pappas:

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.

{1}------------------------------------------------

Page 2 - Mr. John Pappas

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 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,

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Image /page/2/Picture/0 description: The image shows the word "ENDOTEC" in bold, white letters against a black circle. The circle is positioned to the left of the word, with the letters partially overlapping it. The overall design is simple and graphic, with a focus on the contrast between the black circle and the white text.

## INDICATIONS FOR USE

K992394 510(k) Number (if known):

Device Name: BUECHEL-PAPPAS™ Humeral Head Resurfacing Component

Indications For Use:

The BUECHEL-PAPPAS™ Humeral Head Resurfacing Shoulder Component is intended for the reconstruction of painful and/or severely disabled shoulder joints resulting from osteoarthritis and rheumatoid arthritis. For proper function of this device, the humeral head and neck must be of sufficient bone stock to support the loads on it. Also, the presence of an intact or reconstructable rotator cuff is important for proper functioning and dislocation resistance. Biocoat® porous coated components are intended for cemented use only.

## Contraindications

The device is contraindicated for use with forms of post-traumatic arthritis, rotator cuff dysfunction, humeral head avascular necrosis, failed, previous prosthesis, or congenital dysplasia.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Division of General Restorative Devices 510(k) Number K492394

Prescription Use

OR

Over-The-Counter Use

20 Valley Street South Orange, NJ 07079 Tel. [phone] Fax. [phone]