36MM C-TAPER FEMORAL HEAD COMPONENTS (LFIT AND NON-LFIT)

K021310 · Howmedica Osteonics Corp. · JDI · May 21, 2002 · Orthopedic

Device Facts

• Record ID: K021310
• Device Name: 36MM C-TAPER FEMORAL HEAD COMPONENTS (LFIT AND NON-LFIT)
• Applicant: Howmedica Osteonics Corp.
• Product Code: JDI · Orthopedic
• Decision Date: May 21, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3350
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Indications for use as part of a Universal Hip Replacement include: - Femoral neck fractures; . - Non-union of femoral head and neck fractures; . - Aseptic necrosis of the femoral head as well as; - Osteo-, rheumatoid, and post-traumatic arthritis of the hip with minimal acetabular involvement or distortion. Indications for use as part of a Total Hip Replacement include: - Severely disabled joints resulting from painful osteo-, rheumatoid, post-traumatic arthritis ● and late stages of avascular necrosis; - Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other ● procedure as well as; - Other difficult clinical management problems.

Device Story

36mm C-Taper femoral head components designed for use with Howmedica Osteonics hip stems in total hip arthroplasty. Device serves as a bearing surface in hip joint replacement. Fabricated from cobalt chromium alloy. Intended for surgical implantation by orthopedic surgeons in a hospital setting. Provides a larger femoral head option to existing 22mm-32mm product lines. Benefits include restoration of joint function and pain relief for patients with degenerative or traumatic hip conditions.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing and design similarity to predicate devices.

Technological Characteristics

Cobalt chromium alloy conforming to ASTM F1537. 36mm diameter femoral head component. C-Taper geometry. Designed for use with Howmedica Osteonics hip stems. Class II device.

Indications for Use

Indicated for patients requiring total hip arthroplasty or universal hip replacement due to femoral neck fractures, non-union of femoral head/neck fractures, aseptic necrosis, or osteo-, rheumatoid, and post-traumatic arthritis. Also indicated for revision of previous unsuccessful hip procedures and other difficult clinical management problems.

Regulatory Classification

Identification

A hip joint metal/polymer semi-constrained cemented prosthesis is a 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 have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).

Predicate Devices

• 22mm-32mm C-Taper Femoral Head Components (LFIT™ and Non-LFIT™) (K910988, K900836, K982936)

Submission Summary (Full Text)

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Addition of 36mm C-Taper Femoral Heads to the LFITTM and Non-LFITTM Series

Special 510(k) Premarket Notification

MAY 2 1 2002

K021310

page 1 of 1

Special 510(k) Summary - Addition of 36mm C-Taper Femoral Heads To The LFIT™ And Non-LFITTM Series

| | SUBJECT DEVICE | PREDICATE DEVICE |
|---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|
| Proprietary Name: | 36mm C-Taper Femoral Head<br>Components (LFIT™ and Non-<br>LFIT™) | 22mm-32mm C-Taper Femoral<br>Head Components (LFIT™ and<br>Non- LFIT™) |
| Common Name: | Femoral Head Component | Femoral Head Component |
| Classification Name and<br>Reference: | 21 CFR §888.3350<br>Hip Joint Metal/ Polymer Semi-<br>constrained Cemented Prosthesis | 21 CFR §888.3350<br>Hip Joint Metal/ Polymer Semi-<br>constrained Cemented Prosthesis |
| Proposed Regulatory Class: | II | II |
| Device Product Code: | (87) JDI, LWJ, KWY | (87) JDI, LWJ, KWY |
| For Information contact: | Jennifer A. Daudelin, Regulatory Affairs<br>Howmedica Osteonics Corp.<br>59 Route 17<br>Allendale, NJ 07401-1677<br>[phone]<br>Fax: [phone]<br>Email: [e-mail] | |

This Special 510(k) submission is intended to add 36mm C-Taper femoral head components to the LFTTM and non-LFTT™ Femoral Bearing Series. The intended use, manufacturing methods, materials, packaging and sterilization of the subject device are identical to those of predicate devices. The predicate LFTTM C- Taper femoral bearing components were found substantially equivalent via the 510(k) process in K910988 up to the size +10mm offset head. The non-LFIT™ C- Taper femoral head components were cleared in 510(k) number K900836 up to the size +10mm offset head. The +12mm and +15mm offset head components in both the non-LFIT™ and LFIT™ versions were found substantially equivalent in 510(k) #K982936. The C-Taper femoral head components are fabricated from cobalt chromium alloy conforming to ASTM F1537. Like the predicate devices, the subject devices are intended to be used in conjunction with appropriate Howmedica Osteonics hip stems in patients requiring total hip arthroplasty.

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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 is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is a stylized image of an eagle.

## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Jennifer A. Daudelin Regulatory Affairs Specialist Howmedica Osteonics Corp. 59 Route 17 Allendale, NJ 07401-1677

Re: K021310

Trade/Device Name: 36mm C-Taper Femoral Head Components (LFIT™ and Non-LFIT™) Regulation Number: 21 CFR 888.3350 and 21 CFR 888.3390

Regulation Name: Hip joint metal/polymer semi-constrained cemented prosthesis and Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis

Regulatory Class: Class II Product Code: JDI, LWJ, and KWY Dated: April 24, 2002 Received: April 25, 2002

Dear Ms. Daudelin:

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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Page 2 - Ms. Jennifer A. Daudelin

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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 yours,

L. Mark H. Milburn

Celia M. Witten, Ph.D., M.D. 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):

Device Name: 36mm C-Taper Femoral Heads

Indications for Use:

Indications for use as part of a Universal Hip Replacement include:

- Femoral neck fractures; .
- Non-union of femoral head and neck fractures; .
- Aseptic necrosis of the femoral head as well as;
- Osteo-, rheumatoid, and post-traumatic arthritis of the hip with minimal acetabular involvement or distortion.

Indications for use as part of a Total Hip Replacement include:

- Severely disabled joints resulting from painful osteo-, rheumatoid, post-traumatic arthritis ● and late stages of avascular necrosis;
- Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other ● procedure as well as;
- Other difficult clinical management problems.

for Mark M. Milhurn
(Division Sign-C

Division of General. Restorative and Neurological Devices

510(k) Number _

) Number K021310

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Concurrence of CDRH, Office of Device Evaluation (ODE)

OR Prescription Use માં (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)