DEPUY GLOBAL C.AP. CTA RESURFACING SHOULDER

K080990 · DePuy Orthopaedics, Inc. · HSD · Aug 8, 2008 · Orthopedic

Device Facts

• Record ID: K080990
• Device Name: DEPUY GLOBAL C.AP. CTA RESURFACING SHOULDER
• Applicant: DePuy Orthopaedics, Inc.
• Product Code: HSD · Orthopedic
• Decision Date: Aug 8, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The DePuy Global C.A.P.™ CTA Resurfacing Shoulder prosthesis is intended for use in hemi-shoulder arthroplasty.

Device Story

DePuy Global C.A.P. CTA Resurfacing Shoulder is a metallic hemi-shoulder prosthesis for cuff tear arthropathy (CTA). Device features extended articulation surface to maintain contact with coracoacromial arch during abduction; one-piece cobalt-chrome-molybdenum shell (ASTM F-75) with porous coating and plasma-sprayed hydroxyapatite (Duofix) for biological fixation. Stem includes distal cruciate design for press-fit fixation. Implant preserves bone stock compared to total shoulder replacement, facilitating potential future revisions. Used by orthopedic surgeons in clinical settings. Output is a physical implant providing structural replacement of humeral head; clinical benefit includes restoration of joint function and stability in patients with rotator cuff deficiency.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Cobalt-chrome-molybdenum alloy (ASTM F-75) construction. Features porous coating and plasma-sprayed hydroxyapatite (Duofix) coating. Distal stem has cruciate design with tapered tip. Fixation is cementless (press-fit) and biological (tissue in-growth). Sterilization via gamma irradiation.

Indications for Use

Indicated for hemi-shoulder replacement in patients with rotator cuff tears and arthritis, specifically for rotator cuff tear arthropathy and difficult clinical management cases where other treatments are inadequate. Intended for cementless use only.

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 Humeral Head (K000575)
• Copeland™ EAS Humeral Resurfacing Heads (K051843)
• DVO™ Total Extended Articulation Humeral Heads (K073331)
• DePuy Global C.A.P.™ Resurfacing Replacement Shoulder (K031971)
• Copeland™ MB/HA Resurfacing Humeral Heads (K010827)

Reference Devices

• DePuy Global C.A.P.™ HA Resurfacing Shoulder Humeral Heads (K033516)

Submission Summary (Full Text)

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KON990

# 510(k) Summary

AUG - 8 2008

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

| NAME OF SPONSOR: | DePuy Orthopaedics, Inc.<br>700 Orthopaedic Drive<br>Warsaw, Indiana 46581-0988<br>Establishment Registration Number: 1818910 |
|----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| MANUFACTURER: | DePuy Orthopaedics, Inc.<br>700 Orthopaedic Drive<br>Warsaw, Indiana 46581-0988<br>Establishment Registration Number: 1818910 |
| 510(K) CONTACT: | Dawn Sinclair<br>Regulatory Affairs Associate<br>Telephone: [phone]<br>Facsimile: [phone]<br>Electronic Mail: [e-mail] |
| DATE PREPARED: | March 17, 2008 |
| PROPRIETARY NAME: | DePuy Global C.A.P.™ CTA Resurfacing<br>Shoulder |
| COMMON NAME: | Resurfacing Shoulder |
| CLASSIFICATION: | Class II per 21 CFR 888.3690, Shoulder joint<br>humeral (hemi-shoulder) metallic uncemented<br>prosthesis |
| DEVICE PRODUCT CODE: | 87HSD |
| SUBSTANTIALLY EQUIVALENT<br>DEVICE(S): | DePuy Global Advantage® Extended Humeral<br>Head, K000575<br>Copeland™ EAS Humeral Resurfacing Heads,<br>K051843<br>DVO™ Total Extended Articulation Humeral<br>Heads, K073331<br>DePuy Global C.A.P.™ Resurfacing Replacemen<br>Shoulder, K031971<br>Copeland™ MB/HA Resurfacing Humeral Heads,<br>K010827 |

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## DEVICE DESCRIPTION:

The DePuy Global C.A.P.™ CTA Resurfacing Shoulder is a conservative Cuff Tear Arthropathy (CTA) device designed for resurfacing of the humeral head (hemi-shoulder). Resurfacing requires less bone and cartilage removal than is required in total shoulder replacement. Because bone stock is preserved, future revision or arthrodesis can be more easily performed. The prosthesis is intended for uncemented (i.e., press-fit) fixation, and is designed to mimic the normal humeral head geometry.

Composed of a cobalt-chrome-molybdenum allov (ASTM F-75), the DePuy Global C.A.P." CTA Resurfacing Shoulder is available in a variety of diameters. The proposed implant will be available in curvatures of 40. 44. 48. 52 and 56mm. with head heights of 15mm (40 and 44mm curvatures), 18mm (all curvatures) or 21mm (48, 52 and 56mm curvatures).

The proposed humeral head is a one-piece shell, manufactured from cobalt-chromemolybdenum alloy (ASTM F-75). The inner surface of the dome, or humeral head, has a cobalt-chrome-molybdenum porous coating. The stem has a cobalt-chrome-molybdenum porous coating proximally and is glass bead blasted distally. The distal stem has a cruciate design with a tapered distal tip. A thin layer of plasma-sprayed hydroxyapatite (Duofix") has been applied to the inner surface of the dome and proximal stem.

The hydroxyapatite (HA) coating applied to the DePuy Global C.A.P. CTA Resurfacing Shoulder is substantially equivalent to the HA coating process used in previously cleared products (e.g., DePuy Global C.A.P." Resurfacing Replacement Shoulder, K031971; DePuy Global C.A.P." HA Resurfacing Shoulder Humeral Heads, K033516). The composition of the coating is the same as that used for previously cleared products, (e.g., DePuy Global C.A.P." Resurfacing Replacement Shoulder, K031971; DePuy Global CAP™ HA Resurfacing Shoulder Humeral Heads, K033516).

The DePuy Global C.A.P." CTA Resurfacing Shoulder features an extended articulation surface to cover the superior-lateral aspect of the resurfacing head. This additional material keeps the implant surface in contact with the coracoacromial arch for a longer period of time during abduction.

This device also features a stem with a distal cruciate press fit to provide initial fixation. For long-term fixation and implant support, a surface-to-surface contact between the underside of the cup and the humeral head is created because of a flat located on the underside of the cup. Fixation is also provided by biological tissue in-growth into the porous coating.

Prastelli Pro

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#### INTENDED USE AND INDICATIONS FOR USE:

#### Intended Use:

The DePuy Global C.A.P."" CTA Resurfacing Shoulder prosthesis is intended for use in hemi-shoulder arthroplasty.

#### Indications for Use:

The DePuy Global C.A.P."" CTA Resurfacing Shoulder is indicated for hemi-shoulder replacement in patients with rotator cuff tears and arthritis. Specific indications include:

- 1. Rotator cuff tear arthropathy.
- 2. Difficult clinical management problems where other methods of treatment may not be suitable or may be inadequate.

# CAUTION: The DePuy Global C.A.P."" CTA Resurfacing Shoulder is intended for cementless use only.

## BASIS OF SUBSTANTIAL EQUIVALENCE

The DePuy Global C.A.P.™ CTA Resurfacing Shoulder described in this submission is, in our opinion, substantially equivalent to the previously cleared DePuy Global Advantage® Extended Humeral Head (K000575), the Copeland™ EAS Humeral Resurfacing Heads (K051843), the DVO™ Total Extended Articulation Humeral Heads (K073331), the DePuy Global C.A.P." Resurfacing Shoulder (K031971), and the Copeland" MB/HA Resurfacing Humeral Heads (K010827), based upon the similarities in design, material composition (cobalt-chrome-molybdenum alloy), methods of sterilization (gamma irradiation) and intended use/indications for use. 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 seal of the U.S. Department of Health & Human Services. The seal features the department's name in a circular arrangement around a symbol. The symbol is a stylized representation of a staff entwined with a serpent, a common symbol associated with medicine and health.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DePuy Orthopaedics, Inc. % Ms. Dawn Sinclair Regulatory Affairs Associate P. O. Box 988 700 Orthopaedic Drive Warsaw, Indiana 46581-0988

AUG - 8 2008

Re: K080990

Trade/Device Name: DePuy Global C.A.P.TM CTA Resurfacing Shoulder Regulation Number: 21 CFR 888.3690 Regulation Name: Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis Regulatory Class: Class II Product Code: HSD Dated: June 18, 2008 Received: June 19, 2008

Dear Ms. Sinclair:

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, 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 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. Dawn Sinclair

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 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.

Sincerely vours.

Mark N Millican

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 Statement

510 (k) Number (if known): ______________ K080990

Device Name: DePuy Global C.A.P." CTA. Resurfacing Shoulder

Indications for Use:

The DePuy Global C.A.P. ** CTA Resurfacing Shoulder is indicated for hemi-shoulder replacement in patients with rotator cuff tears and arthritis. Specific indications include:

- 1. Rotator cuff tear arthropathy.
- 2. Difficult clinical management problems where other methods of treatment may not be suitable or may be inadequate.

CAUTION: The DePuy Global C.A.P.™ CTA Resurfacing Shoulder is intended for cementless use only.

Prescription Use *X*
(Part 21 CFR 801 Subpart D)

barbara buchner

AND/OR

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

Division of General, Restorative. and Neurological Devices

**510(k) Number** KDS0990

08843