GLOBAL CAP RESURFACING REPLACEMENT SHOULDER

K031971 · DePuy Orthopaedics, Inc. · HSD · Sep 24, 2003 · Orthopedic

Device Facts

• Record ID: K031971
• Device Name: GLOBAL CAP RESURFACING REPLACEMENT SHOULDER
• Applicant: DePuy Orthopaedics, Inc.
• Product Code: HSD · Orthopedic
• Decision Date: Sep 24, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The DePuy Global CAP Resurfacing Replacement Shoulder is intended as a hemi or total shoulder replacement in patients where the humeral head and neck are of sufficient bone stock and the rotator cuff is intact or reconstructable. This device is designed to increase shoulder mobility by: reducing pain; restoring alignment; restoring flexion and extension movement; and resisting dislocation. The DePuy Global CAP Resurfacing Replacement Shoulder is indicated for use as a replacement of shoulder joints disabled by rheumatoid arthritis with pain, noninflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis), deformity and/or limited motion, fractures of the humeral head and traumatic arthritis. CAUTION: The DePuy Global CAP Resurfacing Replacement Shoulder is intended for cementless use only.

Device Story

Global CAP Resurfacing Replacement Shoulder is a cementless humeral head prosthesis; used for hemi or total shoulder replacement. Device restores shoulder alignment, flexion, and extension; reduces pain; resists dislocation. Intended for patients with sufficient bone stock and functional rotator cuff. Implanted by orthopedic surgeons in clinical settings. Device features Cobalt Chrome Molybdenum alloy construction with porocoat application on non-articulating surfaces and proximal stem. Available in 40mm to 56mm curvature sizes and 15mm to 18mm head sizes.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Humeral head prosthesis; material: ASTM F-75 Cobalt Chrome Molybdenum alloy; surface treatment: porocoat on non-articulating surfaces and proximal stem; cementless fixation; curvature sizes 40-56mm; head sizes 15-18mm.

Indications for Use

Indicated for patients requiring hemi or total shoulder replacement with sufficient humeral bone stock and intact/reconstructable rotator cuff. Conditions include rheumatoid arthritis, noninflammatory degenerative joint disease (osteoarthritis, avascular necrosis), deformity, limited motion, humeral head fractures, and traumatic arthritis.

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.

Predicate Devices

• Copeland Shoulder MB/HA Resurfacing Head (K010827)
• DePuy Global Advantage Shoulder (K911686)

Submission Summary (Full Text)

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K031971

SEP 2 4 2003

## 510(k) Summary

2

P. I

| Name of Sponsor: | DePuy Orthopaedics, Inc.<br>700 Orthopaedic Drive<br>Warsaw, Indiana 46581-0988<br>Est. Reg. No. 1818910 |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Contact Person: | Tiffani Rogers<br>Clinical Research Specialist, Product Development<br>Phone: [phone]<br>FAX: [phone] |
| Trade Name: | Global CAP Resurfacing Replacement Shoulder |
| Common Name: | Resurfacing shoulder |
| Classification: | Class II Device per 21 CFR 888.3690:<br>Shoulder joint, humeral (hemi-shoulder), metallic<br>uncemented prosthesis. |
| Device Product Code: | HSD |
| Panel: | Orthopaedic |
| Performance Standards: | No performance standards have been established<br>under Section 514 of the Federal Food, Drug, and<br>Cosmetic Act for humeral shoulder prosthesis. |
| Substantially Equivalent Devices: | Copeland Shoulder MB/HA Resurfacing Head<br>K010827<br>DePuy Global Advantage Shoulder<br>K911686<br>(Formerly the Global Total Shoulder) |
| Device Description: | The Global CAP Resurfacing Shoulder is a<br>cementless humeral head to be used for the<br>treatment of shoulder joints:<br>• The humeral head is made of ASTM F-75<br>Cobalt Chrome Molybdenum alloy with a<br>porocoat application on the non-articulating<br>surface and the proximal stem. Curvature sizes<br>are available in 40mm to 56mm (in 4mm<br>increments) with head sizes of 15mm, 18mm |

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031971

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## 510(k) Summary (continued)

The DcPuy Global CAP Resurfacing Shoulder is Indications for use: intended as a hemi or total shoulder replacement in patients where the humeral head and neck are of sufficient bone stock and the rotator cuff is intact or reconstructable. This device will increase shoulder mobility by: reducing pain; restoring alignment; restoring flexion and extension movement; and resisting dislocation. The DePuy Global CAP Resurfacing Shoulder is indicated for use as a replacement of shoulder joints disabled by rheumatoid arthritis with pain, noninflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis), deformity and/or limited motion, fractures of the humeral head and traumatic arthritis. CAUTION: The DePuy Global CAP Resurfacing Shoulder is intended for cementless use only. Substantial equivalence: The DePuy Global CAP Resurfacing Shoulder is manufactured from the same material, sterilized and packaged in the same fashion and has the same intended use and design features as the predicate devices and is therefore substantially equivalent.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the department's name encircling an abstract symbol. The symbol consists of three stylized human profiles facing right, with flowing lines suggesting movement or connection. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 4 2003

Ms. Tiffani Rogers Clinical Research Specialist, Product Development DePuy Orthopaedics, Inc. 700 Orthopaedic Drive Warsaw, Indiana 46581-0988

Re: K031971

Trade/Device Name: Global CAP Resurfacing Replacement Shoulder Regulation Number: 21 CFR 888.3690 Regulation Name: Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis Regulatory Class: II Product Code: HSD Dated: June 24, 2003 Received: June 26, 2003

Dear Ms. Rogers:

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. Tiffani Rogers

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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

R. Mark N. Milken

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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K03197 510(k) Number (if known):

## Device Name: Global CAP Resurfacing Replacement Shoulder

## Indications for Use:

The DePuy Global CAP Resurfacing Replacement Shoulder is intended as a hemi or total shoulder replacement in patients where the humeral head and neck are of sufficient bone stock and the rotator cuff is intact or reconstructable. This device is designed to increase shoulder mobility by: reducing pain; restoring alignment; restoring flexion and extension movement; and resisting dislocation.

The DePuy Global CAP Resurfacing Replacement Shoulder is indicated for use as a replacement of shoulder joints disabled by rheumatoid arthritis with pain, noninflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis), deformity and/or limited motion, fractures of the humeral head and traumatic arthritis.

CAUTION: The DePuy Global CAP Resurfacing Replacement Shoulder is intended for cementless use only.

Mark N. Milkena

(Division Sign-Off) Division of General. Restorative and Neurological Devices

K031971 510(k) Number

Concurrence of CDRH, Office of Device Evaluation

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use