DEPUY GLOBAL AP CTA HUMERAL HEAD

K082715 · DePuy Orthopaedics, Inc. · HSD · Dec 18, 2008 · Orthopedic

Device Facts

• Record ID: K082715
• Device Name: DEPUY GLOBAL AP CTA HUMERAL HEAD
• Applicant: DePuy Orthopaedics, Inc.
• Product Code: HSD · Orthopedic
• Decision Date: Dec 18, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Global AP CTA Humeral Head, in combination with a Global AP Shoulder humeral stem, is intended for use in hemi-shoulder arthroplasty.

Device Story

The Global AP CTA Humeral Head is a metallic prosthetic component designed for hemi-shoulder arthroplasty. It is used in conjunction with a Global AP Humeral Stem. The device replaces the natural humeral head to restore joint function and alleviate pain in patients with degenerative, traumatic, or necrotic shoulder conditions. It is implanted by an orthopedic surgeon in a clinical/surgical setting. The device provides a mechanical articular surface to facilitate shoulder movement. Benefits include pain relief, improved joint mobility, and restoration of function in cases where alternative treatments are unsatisfactory.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design and material similarities to the predicate device.

Technological Characteristics

Metallic humeral head prosthesis for hemi-shoulder arthroplasty. Designed for use with Global AP Humeral Stems (cemented or cementless options depending on coating).

Indications for Use

Indicated for hemi-shoulder replacement in 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; rotator cuff tear arthropathy; or deformity/limited motion.

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 Advantage Extended Head (K000575)

Submission Summary (Full Text)

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# K082715

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DEC 1 8 2008

#### 510 (k) Summary

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

#### NAME OF SPONSOR:

DePuy Orthopaedics, Inc. 700 Orthopaedic Drive Warsaw, Indiana 46582 Establishment Registration Number: 1818910

MANUFACTURER:

510(K) CONTACT:

PROPRIETARY NAME:

COMMON NAME:

CLASSIFICATION:

DePuy Orthopaedics, Inc. 700 Orthopaedic Drive Warsaw, Indiana 46582 Establishment Registration Number: 1818910

Rhonda Myer Regulatory Affairs Associate Telephone: [phone] Facsimile: [phone] Electronic Mail: [e-mail]

DePuy Global AP CTA Humeral Head

Shoulder Prosthesis, Humeral Head

Class II device per 21 CFR §888.3690: Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis (HSD)

87 HSD Prosthesis, Shoulder, Hemi-, Humeral,

#### DEVICE PRODUCT CODE:

Metallic Uncemented

SUBSTANTIALLY EQUIVALENT DEVICE:

DePuy Global Advantage Extended Head, K000575

#### DEVICE DESCRIPTION:

The Global AP CTA Humeral Head, in combination with a Global AP Shoulder humeral stem, is intended for use in hemi-shoulder arthroplasty.

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082715

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#### INDICATIONS AND INTENDED USE:

#### Indications:

The Global AP CTA Humeral Head, used with a Global AP Humeral Stem, is indicated for use in hemi-shoulder replacement.

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).

Hemi-shoulder replacement is also indicated for:

- 1. Ununited humeral head fractures.
- 2. Avascular necrosis of the humeral head.
- 3. Rotator cuff tear arthropathy.
- 4. Deformity and/or limited motion.

Un-coated Global AP Humeral Stems are indicated for cemented use only. Global AP Humeral Stems with Porocoal® are indicated for cemented or cementless use.

#### Intended Use:

The Global AP CTA Humeral Head, in combination with a Global AP Shoulder humeral stem, is intended for use in hemi-shoulder arthroplasty.

#### BASIS OF SUBSTANTIAL EQUIVALENCE:

Based on the similarities in intended use, indications for use, materials, design, method of manufacture, sterilization and packaging methods, DePuy believes the subject Global AP CTA Humeral Head is substantially equivalent to the previously cleared Global Advantage Extended Head, K000575.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/13 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing health, human services, and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## DEC 1 8 2008

DePuy Orthopaedics, Inc. % Ms. Rhonda Myer Senior Regulatory Affairs Associate 700 Orthopaedic Drive P.O. Box 988 Warsaw, Indiana 46582

Re: K082715

Trade/Devicc Namc: DePuy Global AP CTA Head Regulation Number: 21 CFR 888.3690 Regulation Name: Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis Regulatory Class: II Product Code: IISD Dated: December 3, 2008 Received: December 4, 2008

Dear Ms. Myer:

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 (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, fisting 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 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. Rhonda Myer

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, permitts your cevice to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events. (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number [phone] or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincercly yours,

Mark M. Milliman

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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# K082715

### Indications for Use Statement

510 (k) Number (if known): K082715

Device Name: DePuy Global AP CTA Head

#### Indications for Use:

The Global AP CTA Humeral Head, used with a Global AP Humeral Stem, is indicated for use in hemi-shoulder replacement.

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),

Hemi-shoulder replacement is also indicated for:

- 1. Ununited humeral head fractures.
- 2. Avascular necrosis of the humeral head.
- 3. Rotator cuff tear arthropathy.
- 4. Deformity and/or limited motion.

Un-coated Global AP Humeral Stems are indicated for cemented use only. Global AP Humeral Stems with Porocoat® are indicated for cemented or cementless use.

| Prescription Use | X<br>(Part 21 CFR 801 Subpart D) |
|----------------------|----------------------------------|
| | AND/OR |
| Over-The-Counter Use | (21 CFR 807 Subpart C) |

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Posted November 12, 2003) (Division Sign-Off) Des Dir Page 1 of 1

Division of General, Restorative, and Neurological Devices

| 510(k) Number | L082718 |
|---------------|---------|
|---------------|---------|

DePuy Orthopaedics, Inc.

K082715 Global AP CTA Humeral Head