DEPUY ASPHERE M-SPEC HEAD

K082585 · DePuy Orthopaedics, Inc. · KWA · Dec 4, 2008 · Orthopedic

Device Facts

• Record ID: K082585
• Device Name: DEPUY ASPHERE M-SPEC HEAD
• Applicant: DePuy Orthopaedics, Inc.
• Product Code: KWA · Orthopedic
• Decision Date: Dec 4, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3330
• Device Class: Class 3
• Attributes: Therapeutic

Intended Use

The subject aSphere M-Spec Head is intended for use as part of the femoral component in a total hip arthroplasty.

Device Story

The aSphere M-Spec Head is a modular femoral head component for total hip arthroplasty. It attaches to DePuy femoral stems and articulates with DePuy acetabular inserts and cups. Used by orthopedic surgeons in clinical settings to restore joint function in patients with severe hip pathology. The device replaces the natural femoral head, facilitating movement and reducing pain associated with arthritis, necrosis, or fractures. It functions as a mechanical bearing surface within the hip joint assembly.

Clinical Evidence

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

Technological Characteristics

Modular femoral head component for total hip arthroplasty. Designed for articulation with acetabular inserts and coupling with femoral stems. Mechanical device; no software, electronics, or energy source.

Indications for Use

Indicated for patients with severely painful/disabled joints due to osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia; avascular necrosis of the femoral head; acute traumatic fracture of the femoral head or neck; failed previous surgery (joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or other total hip replacement); and certain cases of ankylosis.

Regulatory Classification

Identification

A hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis is a two-part device intended to be implanted to replace a hip 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 consist of a femoral and an acetabular component, both made of alloys, such as cobalt-chromium-molybdenum. The femoral component is intended to be fixed with bone cement. The acetabular component is intended for use without bone cement (§ 888.3027).

Predicate Devices

• DePuy M-Spec Head 36 mm (K980513)
• DePuy M-Spec Head 40 mm (K060031)
• DePuy M-Spec Head 44 mm (K060031)

Submission Summary (Full Text)

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K082585 pg 1/2

510 (k) Summary

Name of Sponsor:

510(k) Contact:

Manufacturer:

Contract Sterilizer:

Date Prepared: Proprietary Name: Common Name: Classification:

# Device Product Codes:

Substantially Equivalent Devices:

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

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

Rhonda Myer Regulatory Affairs Associate Telephone: [phone] Facsimile: [phone] Electronic Mail: Rinyer7(@)its.jnj.com

DePuy International St. Anthony's Road Beeston Leeds United Kingdom LS11 8DT

Swann-Morton Ltd. Owlerton Green Sheffield S6 2BJ United Kingdom

December 2, 2008

DePuy aSphere M-Spec Head

Modular Femoral Head

Class III per 21 CFR 888.3330: Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis

Class II per 21 CFR 888.3350: Hip joint metal/polymer semi-constrained cemented prosthesis

Class II per 21 CFR 888.3358: Hip joint metal/polymer/metal semi-constrained porouscoated uncemented prosthesis

87 KWA, 87 JDI, and 87 LPH

DePuy M-Spec Head 36 mm: K980513 and internal documentation to K851422 40 mm and 44 mm: K060031

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K082585 pg 2/2

## Device Description:

The aSphere M-Spec Head is part of a modular prosthesis system for use in total hip replacement. It mates with DePuy femoral stems and articulates with DePuy acetabular inserts and cups.

#### Indications for Use:

The DePuy aSphere M-Spec Head is indicated for use in the treatment of:

- 1. A severely painful and/or a severely disabled joint resulting from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia;
- 2. Avascular necrosis of the femoral head;
- 3. Acute traumatic fracture of the femoral head or neck;
- 4. Failed previous surgery, including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthoplasty, or other total hip replacement; and
- 5. Certain cases of ankylosis.

#### Intended Use:

The subject aSphere M-Spec Head is intended for use as part of the femoral component in a total hip 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 aSphere M-Spec Head is substantially equivalent to the previously cleared DePuy M-Spec Head, cleared in K980513, internal documentation to K851422, and K060031.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The logo is black and white.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DePuy Orthopaedics, Inc. % Ms. Rhonda Myer Regulatory Affairs Associate 700 Orthopaedic Dr. Warsaw, Indiana 46581

# DEC 0 4 2008

Re: K082585

Trade/Device Name: DePuy aSpehere M-Spec Head Regulation Number: 21 CFR 888.3330 Regulation Name: Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis Regulatory Class: III Product Code: KWA, JDI, LPH Dated: November 5, 2008

Received: November 6, 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 for use saled in the enactment date of the enactment date of the Medical Device Amendments, or to conninered price to may 2008sified 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 I ou may, dicrerere, mains 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 or any I cocial suttated and regisments, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CITY at 607); intoning (21 CFR 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, 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 yours,

Mark N. Millerson

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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5.10 (k) Number (if known): YOB2585 (pay) / 1)

Device Name: DePuy aSphere M-Spec Head

Indications for Use:

The DePuy aSphere M-Spec Head is indicated for use in the treatment of:

- 1. A severely painful and/or a severely disabled joint resulting from osteoarthritis, traumatic arthritis, or rheumatoid arthritis, or congenital hip'dysplasia;
- 2. Avascular necrosis of the femoral head;
- 3. Acute traumatic fracture of the femoral head or neck;
- 4. Failed previous surgery, including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthoplasty, or other total hip replacement; and
- Certain cases of ankylosis. న.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE) (Posted November 13, 2003) age 1 of 1 (Division 3155) Division of General, Restorative,

DePuy Orthopaedics, Inc.

and Neurological Devices

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510(k) Number _ K of 2585