SMITH & NEPHEW MODULAR FEMORAL (HEMI) HEAD

K062408 · Smith & Nephew, Inc. · KWL · Sep 12, 2006 · Orthopedic

Device Facts

• Record ID: K062408
• Device Name: SMITH & NEPHEW MODULAR FEMORAL (HEMI) HEAD
• Applicant: Smith & Nephew, Inc.
• Product Code: KWL · Orthopedic
• Decision Date: Sep 12, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3360
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Smith & Nephew Modular Femoral Heads are indicated for the following: Noninflammatory degenerative joint disease: including osteoarthritis, osteonecrosis, avascular necrosis and post traumatic arthritis; rheumatoid arthritis; arthritis secondary to a variety of diseases and anomalies and correction of functional deformity such as congenital hip dysplasia or ankylosing spondylitis; revision procedures where other treatments have failed; and treatment of proximal femoral non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement. The modular femoral heads are for single use only and are intended to be used as part of a hemi-hip replacement system when articulating against the natural acetabulum.

Device Story

Modular femoral heads designed for hemi-hip replacement; fabricated from cobalt chrome (CoCr). Features female Morse-type taper modified to accept taper sleeves for variable neck length offsets; sleeves utilize 12/14 female taper for attachment to Smith & Nephew femoral stems. Intended for single use; implanted by orthopedic surgeons during hip replacement procedures. Provides articulation against natural acetabulum to restore joint function in patients with degenerative disease or fractures.

Clinical Evidence

No clinical data provided; substantial equivalence based on design, material, and intended use similarities to legally marketed predicate devices.

Technological Characteristics

Material: Cobalt chrome (CoCr). Design: Modular femoral head with female Morse-type taper; includes taper sleeves for neck length adjustment. Interface: 12/14 female taper for stem attachment. Sizes: 38-58mm. Single-use. Mechanical device; no software or electronics.

Indications for Use

Indicated for patients with noninflammatory degenerative joint disease (osteoarthritis, osteonecrosis, avascular necrosis, post-traumatic arthritis), rheumatoid arthritis, arthritis secondary to disease/anomalies, functional deformity (congenital hip dysplasia, ankylosing spondylitis), revision cases, or proximal femoral fractures (non-union, neck, trochanteric). For use in hemi-hip replacement systems articulating against natural acetabulum.

Regulatory Classification

Identification

A hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis is a device intended to be implanted to replace a portion of the hip joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum. This generic type of device includes designs which are intended to be fixed to the bone with bone cement (§ 888.3027) as well as designs which have large window-like holes in the stem of the device and which are intended for use without bone cement. However, in these latter designs, fixation of the device is not achieved by means of bone ingrowth.

Predicate Devices

• Smith & Nephew Modular Femoral Heads (K061243)
• Smith & Nephew Uni-Polar Head (K896580)

Submission Summary (Full Text)

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K06 2408 (1 of 1)

### 510(K) Summary Smith & Nephew Modular Femoral (Hemi) Heads

1 2 2006

| SUBMITTER'S NAME: | Smith & Nephew, Inc., Orthopaedic Division |
|-----------------------------------|-----------------------------------------------------------------------------------------|
| SUBMITTER'S ADDRESS: | 1450 East Brooks Road, Memphis, TN 38116 |
| SUBMITTER'S TELEPHONE NUMBER: | 901-399-6707 |
| CONTACT PERSON: | Gino J. Rouss |
| DATE SUMMARY PREPARED: | August 15, 2006 |
| TRADE OR PROPRIETARY DEVICE NAME: | Smith & Nephew Modular Femoral (Hemi) Heads |
| COMMON OR USUAL NAME: | Artificial Hip Replacement Prosthesis |
| CLASSIFICATION NAME: | Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis, 2 CFR 888.3360 |
| DEVICE CLASS: | Class II |
| PANEL CODE: | KWL - prosthesis, hip, hemi-, femoral, metal<br>Orthopedics Panel/87 |

#### A. INTENDED USE:

The Smith & Nephew Modular Femoral Heads are indicated for the following:

- Noninflammatory degenerative joint disease: including osteoarthritis, osteonecrosis, avascular . necrosis and post traumatic arthritis;
- rheumatoid arthritis; .
- arthritis secondary to a variety of diseases and anomalies and correction of functional deformity . such as congenital hip dysplasia or ankylosing spondylitis;
- revision procedures where other treatments: have failed; and .
- treatment of proximal femoral non-union, femoral neck fracture, and trochanteric fractures of the . proximal femur with head involvement.

The modular femoral heads are for single use only and are intended to be used as part of a hemi-hip replacement system when articulating against the natural acetabulum.

#### DEVICE DESCRIPTION: B.

New cobalt chrome (CoCr) modular femoral heads have been designed and developed by Smith & Nephew Orthopaedics. The subject devices are offered in sizes ranging from 38-58mm and feature a female Morse-type taper that has been modified to accept taper sleeves that create a variety of neck length offsets. The taper sleeves feature a 12/14 female taper for attachment to the trunnion of a commercially-available Smith & Nephew femoral siem. The component is based upon the existing Smith & Nephew Modular Heads: and Uni-polar implants subject of K061243 and K896580, respectively.

#### C. SUBSTANTIAL EQUIVALENCE INFORMATION:

The Smith & Nephew Modular Femoral (Hemi) Heads are similar to the following commercially available devices regarding design features, overall indications, and materials:

- · Smith & Nephew Modular Femoral Heads (K061243)
- = Smith & Nephew Uni-Polar Head (K896580)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three wings, representing health, human services, and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 2 2006

Smith & Nephew Orthopaedics c/o Mr. Gino J. Rouss Project Manager, Regulatory Affairs 1450 East Brooks Road Memphis, Tennessee 38116

Re: K062408

Trade/Device Name: Smith & Nephew Modular Femoral (Hemi) Heads Regulation Number: 21 CFR 888.3360 Regulation Name: Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis Regulatory Class: Class II Product Code: KWL Dated: August 15, 2006 Received: August 17, 2006

Dear Mr. Rouss:

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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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,

Barbara Buelow

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): KO62408

## Device Name: Smith & Nephew Modular Femorial Heads

### Indications for Use:

The Smith & Nephew Modular Femoral Heads are indicated for the following:

- Noninflammatory degenerative joint disease including osteoarthritis, osteonecrosis, . avascular necrosis and post traumatic arthritis;
- rheumatoid arthritis; .
- arthritis secondary to a variety of diseases and anomalies and correction of functional . deformity such as congenital hip dysplasia or ankylosing spondylitis;
- revision procedures where other treatments have failed; and .
- treatment of proximal femoral non-union, femoral neck fracture, and trochanteric . fractures of the proximal femur with head involvement.

The modular femoral heads are for single use only and are intended to be used as part of a hemihip replacement system when articulating against the natural acetabulum.

× Prescription Use (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)

Barbara Buchner

510(k) Number K062476

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