DEPUY GLOBAL AP SHOULDER SYSTEM

K060874 · DePuy Orthopaedics, Inc. · KWS · Jun 28, 2006 · Orthopedic

Device Facts

• Record ID: K060874
• Device Name: DEPUY GLOBAL AP SHOULDER SYSTEM
• Applicant: DePuy Orthopaedics, Inc.
• Product Code: KWS · Orthopedic
• Decision Date: Jun 28, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3660
• 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 AP™ Shoulder System is intended for cemented and cementless use.

Device Story

Global AP Shoulder System comprises metal humeral stem, metal head, and taper assembly for total or hemi-shoulder arthroplasty. Used with previously cleared UHMWPE or crosslinked UHMWPE glenoids. Implanted by orthopedic surgeons in clinical settings to replace proximal humerus. Humeral components allow cemented or cementless fixation; glenoid components require bone cement. Device restores joint function, reduces pain, and addresses complex fractures or necrosis by providing artificial articular surface. Clinical decision-making relies on surgeon assessment of joint pathology and bone quality.

Clinical Evidence

No clinical data provided; substantial equivalence based on design and material characteristics.

Technological Characteristics

Shoulder prosthesis consisting of metal humeral stem, metal head, and taper assembly. Materials and design consistent with predicate shoulder systems. Intended for cemented or cementless use. No software or electronic components.

Indications for Use

Indicated for patients with severely painful/disabled joints due to osteoarthritis, traumatic arthritis, or rheumatoid arthritis; proximal humerus fracture-dislocations with comminution or vascular compromise; revision of failed primary components; ununited humeral head fractures; avascular necrosis; or deformity/limited motion.

Regulatory Classification

Identification

A shoulder joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a shoulder 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 humeral resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a glenoid resurfacing component made of ultra-high molecular weight polyethylene, and is limited to those prostheses intended for use with bone cement (§ 888.3027).

Special Controls

*Classification.* Class II. The special controls for this device are:(1) FDA's: (i) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ” (ii) “510(k) Sterility Review Guidance of 2/12/90 (K90-1),” (iii) “Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement,” (iv) “Guidance Document for the Preparation of Premarket Notification (510(k)) Application for Orthopedic Devices,” and (v) “Guidance Document for Testing Non-articulating, ‘Mechanically Locked’ Modular Implant Components,” (2) International Organization for Standardization's (ISO): (i) ISO 5832-3:1996 “Implants for Surgery—Metallic Materials—Part 3: Wrought Titanium 6-aluminum 4-vandium Alloy,” (ii) ISO 5832-4:1996 “Implants for Surgery—Metallic Materials—Part 4: Cobalt-chromium-molybdenum casting alloy,” (iii) ISO 5832-12:1996 “Implants for Surgery—Metallic Materials—Part 12: Wrought Cobalt-chromium-molybdenum alloy,” (iv) ISO 5833:1992 “Implants for Surgery—Acrylic Resin Cements,” (v) ISO 5834-2:1998 “Implants for Surgery—Ultra-high Molecular Weight Polyethylene—Part 2: Moulded Forms,” (vi) ISO 6018:1987 “Orthopaedic Implants—General Requirements for Marking, Packaging, and Labeling,” and (vii) ISO 9001:1994 “Quality Systems—Model for Quality Assurance in Design/Development, Production, Installation, and Servicing,” and (3) American Society for Testing and Materials': (i) F 75-92 “Specification for Cast Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implant Material,” (ii) F 648-98 “Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants,” (iii) F 799-96 “Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants,” (iv) F 1044-95 “Test Method for Shear Testing of Porous Metal Coatings,” (v) F 1108-97 “Specification for Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,” (vi) F 1147-95 “Test Method for Tension Testing of Porous Metal,” (vii) F 1378-97 “Standard Specification for Shoulder Prosthesis,” and (viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.”

Predicate Devices

• DePuy Global Advantage Shoulder System (K992065)
• Sulzer Anatomical Shoulder System with Removable Heads (K030259)
• Sulzer Orthopedics Anatomica Humeral Stem/Head (K990137)

Submission Summary (Full Text)

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JUN 2 8 2006

K060874 page 1 of 2

Pursuant to Section 510(k) of the Federal Food, Drug, and Cosmetic Act and in accordance with subpart E of Part 807 of Title 21 of the Code of Federal Regulations and the Safe Medical Devices Act of 1990.

## 510(k) SUMMARY

| NAME OF FIRM: | DePuy Orthopaedics, Inc.<br>700 Orthopaedic Drive<br>Warsaw, IN 46580 |
|--------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(K) CONTACT: | Natalie S. Heck<br>Manager, Regulatory Affairs<br>DePuy Orthopaedics, Inc.<br>PO Box 988<br>700 Orthopaedic Drive<br>Warsaw, IN 46581-0988 |
| TRADE NAME: | DePuy Global APTM Shoulder System |
| COMMON NAME: | Shoulder Prosthesis |
| CLASSIFICATION: | Class II, per 21 CFR, 888.3660<br>Shoulder joint metal/polymer semi-constrained<br>cemented prosthesis<br>Class II, per 21 CFR 888.3690<br>Shoulder joint metallic, hemi humeral, uncemented<br>prosthesis |
| DEVICE PRODUCT CODE: | 87 KWS<br>87 HSD |
| SUBSTANTIALLY<br>EQUIVALENT DEVICES: | DePuy Global™ Advantage Shoulder System<br>Sulzer Anatomical Shoulder System with Removable<br>Heads<br>Sulzer Orthopedics Anatomica Humeral Stem/Head |

#### DEVICE DESCRIPTION:

The Global AP™ Shoulder Prosthesis consists of individually packaged metal humeral stem, metal head, taper assembly for use in total shoulder arthroplasty. In addition, previously cleared DePuy Global UHMWPE or crosslinked UHMWPE glenoids are used as compatible components in total shoulder arthroplasty.

A Hemi-Shoulder Prosthesis replaces the proximal humerus by either resurfacing the head or using a metal humeral stem and head in hemi-shoulder arthroplasty.

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KC60874

page 27

# INDICATIONS AND INTENDED USE:

### 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 APIM Shoulder System is intended for cemented and cementless use.

# Indications:

Total Shoulder or hemi-shoulder replacement is indicated for:

- 1. 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 APTM Shoulder are intended for cemented or cementless use as a total or hemi-shoulder replacement.

Glenoid components of the Global APTM 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.

# BASIS OF SUBSTANTIAL EQUIVALENCE:

The Depuy Global AP™ Shoulder System is substantially equivalent to the previously cleared DePuy Global Advantage Shoulder System (K992065), the Sulzer Anatomical Shoulder System with Removable Heads (K030259), and the Sulzer Orthopedics Anatomica Humeral Stem/Head (K990137) 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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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is facing right. Encircling the eagle is the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES UNITED STATES OF AMERICA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 8 2006

DePuy Orthopaedics, Inc. c/o Ms. Natalie Heck Manager, Regulatory Affairs 700 Orthopaedic Drive P.O. Box 988 Warsaw, Indiana 46581-0988

Re: K060874

Trade/Device Name: Global APTM Shoulder System Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis. Regulatory Class: II Product Code: KWS, HSD Dated: June 15, 2006 Received: June 19, 2006

Dear Ms. Heck:

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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (sec 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. Natalie Heck

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 logally marketed predicate device results in a classification for your device and thus, permitts 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 oldain 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 vours.

Barbara Buelm

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

Enclosure

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## Indications for Use

510(k) Number (if known): K06874 Device Name: Global APTM Shoulder System

Indications for Use:

Total Shoulder or hemi-shoulder replacement is :ndicated for:

- 1. A severely painful and/or disabled joint : esulting from ostcoarthritis, traumatic arthritis or rheumatoid arthritis.
- Fracture-dislocations of the proximal humerus where the articular surface is ni 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 3. 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.

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

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

| Prescription Use | X |
|-----------------------------|--------|
| | AND/OR |
| (Part 21 CFR 801 Subpart D) | |
| Over-The-Counter Use | No |
| (21 CFR 807 Subpart C) | |

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

(Posted November 13, 2003)

Division of General, Restorative, and Neurological Devices

| 510(k) Number | K060874 |
|---------------|---------|
|---------------|---------|

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