GLOBAL AP POROUS COATED HUMERAL STEM

K063652 · DePuy Orthopaedics, Inc. · MBF · Feb 1, 2007 · Orthopedic

Device Facts

• Record ID: K063652
• Device Name: GLOBAL AP POROUS COATED HUMERAL STEM
• Applicant: DePuy Orthopaedics, Inc.
• Product Code: MBF · Orthopedic
• Decision Date: Feb 1, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3670
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The subject humeral stem is designed for use as the portion of the shoulder prosthesis that replaces the proximal humerus upon which a prosthetic humeral head is attached to articulate with the natural glenoid fossa or a prosthetic glenoid replacement. The DePuy Global APTM Porous Coated Humeral Stems are intended for cemented or cementless use, with fixation provided by biological tissue ingrowth into the porous coating.

Device Story

The DePuy Global APTM Porous Coated Humeral Stem is a shoulder prosthesis component designed to replace the proximal humerus. It is manufactured from titanium alloy with a commercially pure titanium porous coating to facilitate biological tissue ingrowth for cementless fixation, though it may also be used with bone cement. The device is available in six sizes. It is intended for use by orthopedic surgeons in a clinical/surgical setting to restore joint function in patients with severe arthritis, fractures, or necrosis. The stem articulates with either the natural glenoid fossa or a prosthetic glenoid component. The device provides a structural foundation for the prosthetic humeral head, aiming to alleviate pain and improve joint mobility.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Materials: Titanium alloy stem with commercially pure titanium porous coating. Design: Porous-coated uncemented or cemented humeral prosthesis. Available in six sizes. Sterilization: Not specified.

Indications for Use

Indicated for patients requiring total or hemi-shoulder replacement due to: osteoarthritis, traumatic arthritis, rheumatoid arthritis, proximal humerus fracture-dislocations (comminuted/avascular), revision of failed primary components, ununited humeral head fractures, avascular necrosis of the humeral head, or deformity/limited motion. Glenoid components indicated only for cemented use.

Regulatory Classification

Identification

A shoulder joint metal/polymer/metal nonconstrained or semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a shoulder joint. The device limits movement in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a humeral component made of alloys such as cobalt-chromium-molybdenum (Co-Cr-Mo) and titanium-aluminum-vanadium (Ti-6Al-4V) alloys, and a glenoid resurfacing component made of ultra-high molecular weight polyethylene, or a combination of an articulating ultra-high molecular weight bearing surface fixed in a metal shell made of alloys such as Co-Cr-Mo and Ti-6Al-4V. The humeral component and glenoid backing have a porous coating made of, in the case of Co-Cr-Mo components, beads of the same alloy or commercially pure titanium powder, and in the case of Ti-6Al-4V components, beads or fibers of commercially pure titanium or Ti-6Al-4V alloy, or commercially pure titanium powder. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. This generic type of device is designed to achieve biological fixation to bone without the use of bone cement.

Special Controls

*Classification.* Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance: Shoulder Joint Metal/Polymer/Metal Nonconstrained or Semi-Constrained Porous-Coated Uncemented Prosthesis.”

Predicate Devices

• DePuy Global APTM Shoulder System (K060874)
• Global® Advantage Shoulder Humeral Stem with Porocoat® (K011047)

Submission Summary (Full Text)

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K 063652 pg 143

## Section 5 - 510 (k) Summary

(As required by 21 CFR 807.92(c) and 21 CFR 807.93)

| NAME OF SPONSOR: | DePuy Orthopaedics, Inc.<br>700 Orthopaedic Drive<br>Warsaw, Indiana 46582<br>Establishment Registration Number: 1818910 | FEB - 1 200 |
|-------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| 510(K) CONTACT: | Rebecca Lennard<br>Regulatory Affairs Associate II<br>Telephone: [phone]<br>Facsimile: [phone]<br>Electronic Mail: [e-mail] | |
| ALTERNATE 510(K) CONTACT: | Natalie Heck<br>Manager, Regulatory Affairs<br>Telephone: [phone]<br>Facsimile: [phone]<br>Electronic Mail: [e-mail] | |
| DATE PREPARED: | August 16, 2006 | |
| PROPRIETARY NAME: | DePuy Global APTM Porous Coated Humeral<br>Stem | |
| COMMON NAME: | Shoulder Prosthesis | |
| CLASSIFICATION: | Class II Device per 21 CFR 888.3670: Shoulder<br>joint metal/polymer/metal nonconstrained or<br>semi-constrained porous-coated uncemented<br>prosthesis | |
| | Class II Device per 21 CFR 888.3660: Shoulder<br>joint metal/polymer semi-constrained cemented<br>prosthesis | |
| DEVICE PRODUCT CODE: | 87 MBF<br>87 KWS | |
| SUBSTANTIALLY EQUIVALENT<br>DEVICE: | DePuy Global APTM Shoulder System, K060874<br>Global® Advantage Shoulder Humeral Stem with<br>Porocoat®, K011047 | |

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### DEVICE DESCRIPTION:

The subject Global APTM humeral stems are made from titanium alloy and are porouscoated with commercially pure titanium. The stems are available in six sizes. They are identical in design to the Global APTM Humeral Stems cleared in K060874 on June 28, 2006 with the addition of Porocoat® porous coating applied to the proximal portion of the stem.

### INTENDED USE AND INDICATIONS:

### Intended Use:

The subject humeral stem is designed for use as the portion of the shoulder prosthesis that replaces the proximal humerus upon which a prosthetic humeral head is attached to articulate with the natural glenoid fossa or a prosthetic glenoid replacement. The DePuy Global APTM Porous Coated Humeral Stems are intended for cemented or cementless use, with fixation provided by biological tissue ingrowth into the porous coating.

### Indications for Use:

Total Shoulder or hemi-shoulder replacement is indicated for:

- l . A severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis.
- 2. Fracture-dislocations of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon's experience indicates that alternative methods of treatment are unsatisfactory.
- 3. Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. revision of a failed primary component).

The humeral components of the Global AP™ Shoulder are intended for cemented or cementless use as a total or hemi-shoulder replacement.

Global APTM Porous Coated Humeral Stems are intended for cemented or cementless use, with fixation provided by biological tissue ingrowth into the porous coating.

Glenoid components of the Global AP™ Shoulder are indicated only for use with bone cement for the above indications.

Hemi-shoulder replacement is also indicated for:

- 1. Ununited humeral head fractures;
- 2. Avascular necrosis of the humeral head.
- 3. Deformity and/or limited motion.

## 0000014

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Page 143

### BASIS OF SUBSTANTIAL EQUIVALENCE:

The DePuy Global AP™ Porous Coated Humeral Stem is substantially equivalent to the previously cleared DePuy Global APTM Shoulder System (K060874) and the Global® Advantage Shoulder Humeral Stem with Porocoat® (K011047) based upon intended use, indications for use, design, materials, packaging and sterilization. The subject device does not raise any new issues of safety or effectiveness.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the emblem.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DePuy Orthopaedics, Inc. % Ms. Rebecca Lennard Regulatory Affairs Associate II 700 Orthopaedic Drive Warsaw, Indiana 46582

FEB - 1 2007

Re: K063652

Trade/Device Name: DePuy Global AP™ Porous Coated Humeral Stem Regulation Number: 21 CFR 888.3670 Regulation Name: Shoulder joint metal/polymer/metal non-constrained or semiconstrained porous-coated uncemented prosthesis Regulatory Class: Class II Product Code: MBF, KWS Dated: December 7, 2006

Received: December 8, 2006

Dear Ms. Lennard:

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. Rebecca Lennard

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" (21 CFR 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 240-276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Farbare Bonelum

Mark N. Melker Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### Section 4 - Indications for Use Statement

510 (k) Number (if known): ____K063652________________________________________________________________________________________________________________________________________

Device Name: ________________________________________________________________________________________________________________________________________________________________

### Indications for Use:

Total Shoulder or hemi-shoulder replacement is indicated for:

- A severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or 1. rheumatoid arthritis.
- 2. Fracture-dislocations of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon's experience indicates that alternative methods of treatment are unsatisfactory.
- Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are 3. not acceptable (e.g. revision of a failed primary component).

The humeral components of the Global APTM Shoulder are intended for cemented or cementless use as a total or hemi-shoulder replacement.

Global APTM Porous Coated Humeral Stems are intended for cemented or cementless use, with fixation provided by biological tissue ingrowth into the porous coating.

Glenoid components of the Global AP™ Shoulder are indicated only for use with bone cement for the above indications.

Hemi-shoulder replacement is also indicated for:

- 1. Ununited humeral head fractures;
- 2. Avascular necrosis of the humeral head.
- 3. Deformity and/or limited motion.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

510(k) Number_Kole36 Ste

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(Please do not write below this line. Continue on another page if needed.)

UUUUTAA

| Concurrence of CDRH, Office of Device Evaluation (ODE) |
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