DEPUY GLOBAL CAP HA RESURFACING SHOULDER HUMERAL HEADS

K033516 · DePuy Orthopaedics, Inc. · HSD · Dec 3, 2003 · Orthopedic

Device Facts

• Record ID: K033516
• Device Name: DEPUY GLOBAL CAP HA RESURFACING SHOULDER HUMERAL HEADS
• Applicant: DePuy Orthopaedics, Inc.
• Product Code: HSD · Orthopedic
• Decision Date: Dec 3, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The DePuy Global CAP™ HA Resurfacing Shoulder Humeral Heads are 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™ HA Resurfacing Shoulder Humeral Heads are indicated for use as a replacement of shoulder joints disabled by rheumatoid arthritis with pain, non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis), deformity and/or limited motion, fractures of the humeral head and traumatic arthritis. The DePuy Global CAP™ HA Resurfacing Shoulder Humeral Heads are intended for cementless use only.

Device Story

Cobalt chrome molybdenum (ASTM F-75) humeral head shell; porous-coated proximal stem; grit-blasted distal stem; cruciate design; plasma-sprayed hydroxyapatite (HA) coating. Used for hemi or total shoulder replacement; cementless fixation. Designed to restore shoulder mobility, reduce pain, and improve alignment. Implanted by orthopedic surgeons in clinical settings.

Clinical Evidence

No clinical data provided; substantial equivalence based on design, material, and process similarities to predicate devices.

Technological Characteristics

Material: Cobalt chrome molybdenum alloy (ASTM F-75). Coating: Plasma-sprayed hydroxyapatite (HA). Design: One-piece shell, 2mm wall thickness, tapered cruciate stem. Fixation: Cementless. Sterilization: Not specified.

Indications for Use

Indicated for patients requiring hemi or total shoulder replacement with sufficient bone stock and intact/reconstructable rotator cuff. Conditions include rheumatoid arthritis, non-inflammatory 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

• DePuy Global CAP Resurfacing Replacement Shoulder (K031971)

Reference Devices

• Triflange acetabular cup system (K001277)

Submission Summary (Full Text)

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K03516

510(k) Summary

| NAME OF SPONSOR: | DePuy Orthopaedics, Inc.<br>700 Orthopaedic Drive<br>Warsaw, Indiana 46581-0988<br>Est. Reg. No. 1818910 | |
|--------------------------------------|------------------------------------------------------------------------------------------------------------------|--|
| 510(K) CONTACT: | Tiffani D. Rogers<br>Regulatory Associate<br>Phone: [phone]<br>FAX: [phone] | |
| TRADE NAME: | DePuy Global CAPTM HA Resurfacing<br>Shoulder Humeral Heads | |
| 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 | |
| SUBSTANTIALLY EQUIVALENT<br>DEVICES: | Humeral Head: DePuy Global CAP<br>Resurfacing Replacement Shoulder, K031971 | |

#### DEVICE DESCRIPTION:

The DePuy Global CAP™ HA Resurfacing Shoulder Humeral Heads are composed of a cobalt chrome molybdenum alloy (ASTM F-75), and are available in a variety of diameters. This device will be available in curvatures of 40, 44, 48, 52 and 56mm, all available with head heights of 15mm (short), 18mm (medium) or 21mm (large) (Exhibit 1). This proposed range of sizes is designed to fit the natural range of the humeral head anatomy. This range and combination of head diameters and head heights have been cleared in the Global Advantage Humeral Head Premarket Notification (K031971). The stem is a tapered cruciate design intended to provide maximum fixation and stability when impacted in the humerus.

The humeral head is a onc-piece shell with 2mm thick wall. The stem has a cobalt chrome porous coating proximally and is grit blasted distally. The distal stem has a cruciate design and tapers down to the distal tip. The distal tip has a 58° radius. A thin layer of plasma sprayed hydroxyapatite (HA) has been applied to the humeral heads.

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## 510(k) Summary (cont.)

#### INTENDED USE AND INDICATIONS:

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

The DePuy Global CAP™ HA Resurfacing Shoulder Humeral Heads are intended for cementless use only.

### BASIS OF SUBSTANTIAL EQUIVALENCE:

Based on similarities of design, materials, sterilization processes and the same intended use, DePuy believes that the Global CAP™ HA Resurfacing Shoulder Humeral Heads are substantially equivalent to the previously cleared Global CAP Resurfacing Replacement Shoulder, K031971.

DePuy believes the hydroxyapatite (HA) coating applied to the Global CAP™ HA Resurfacing Shoulder Humeral Heads is substantially equivalent to the HA coating process used in previously cleared products. The composition of the same as that used for previously cleared products, i.e. Triflange acctabular cup system (K001277). However, the Global CAP™ HA Resurfacing Shoulder Humeral Heads features a HA coating applied to a Cobalt Chrome porous coating while all other products consists of a HA coating on Titanium. Characterization data for the HA coating on Cobalt Chrome is provided in Exhibit 4. Process specifications for the application of a HA coating to Titanium have been provided previously in Master File MAF 339.

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DEC - 3 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Tiffani D. Rogers Regulatory Affairs Associate DePuy Orthopedics, Inc. 700 Orthopaedic Drive Warsaw, Indiana 46581-0988

Re: K033516

Trade/Device Name: Global CAP™ HA Resurfacing Shoulder Humeral Heads Regulation Number: 21 CFR 888.3690 Regulation Name: Shoulder joint humeral (hemi-shoulder) metallic unccmented prosthesis Regulatory Class: II Product Code: HSD Dated: November 5, 2003 Received: November 7, 2003

Dear Ms. Rogers:

We have reviewed your Scction 510(k) premarket notification of intent to market the device we nave reviewed your becamined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for assessment to May 28, 1976, the enactment date of the Medical Device Amendments, or to eonimered provises that have been reclance 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 r ou may, ateres, orovisions of the Act include requirements for annual registration, listing of general controls pro researce, labeling, and prohibitions against misbranding and adultcration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device to such additional controls. Existing major regulations affecting your device can may or satifyer to basis we 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 r lease be actived that i be mination that your device complies with other requirements of the Act that 1 197 her interes and regulations administered by other Federal agencies. You must or any I oderal state act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 Clik Part 801); good manufacturing practice requirements as set Of N Fart 0777, accems (QS) regulation (21 CFR Part 820); and if applicable, the clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Tiffani D. Rogers

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter with anow you to begal finding of substantial equivalence of your device to a legally premarket notineation. The Presults 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 11 you demre specific at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain Misoralianing of Telerenes of pur responsibilities under the Act from the Division of Small other general miorinational 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,

Mark A. Milkison

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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510(k) Number (if known):_K0335/b

# Device Name: Global CAP™ HA Resurfacing Shoulder Humeral Heads

### Indications for Use:

The DePuy Global CAP™ HA Resurfacing Shoulder Humeral Heads are 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 DcPuy Global CAP™ HA Resurfacing Shoulder Humeral Heads are indicated for use as a replacement of shoulder joints disabled by rheumatoid arthritis with pain, non-inflammatory 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™ HA Resurfacing Shoulder Humeral Heads are intended for cementless use only.

Concurrence of CDRH, Office of Device Evaluation

| | <div> <i>Division Sign-Off)</i> </div> <div>Division of General, Restorative</div> <div>and Neurological Devices</div> |
|-----------------------|------------------------------------------------------------------------------------------------------------------------|
| <div>K() Number</div> | K033576 |

| Prescription Use (Per 21 CFR 801.109) | OR | Over-The-Counter Use |
|---------------------------------------|----|----------------------|
|---------------------------------------|----|----------------------|