36MM V40 FEMORAL HEAD COMPONENTS (LFIT AND NON-LFIT)

K022077 · Howmedica Osteonics Corp. · JDI · Jul 25, 2002 · Orthopedic

Device Facts

• Record ID: K022077
• Device Name: 36MM V40 FEMORAL HEAD COMPONENTS (LFIT AND NON-LFIT)
• Applicant: Howmedica Osteonics Corp.
• Product Code: JDI · Orthopedic
• Decision Date: Jul 25, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3350
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

These devices are modular components of a total hip system. These femoral heads are intended for use with femoral stems and acetabular components in primary or revision total hip arthroplasty.

Device Story

Modular femoral head components; 36mm diameter; various offsets (-5mm, +0mm, +5mm, +10mm). Used as part of total hip system with femoral stems and acetabular components. Implanted by orthopedic surgeons during primary or revision total hip arthroplasty. Provides articulating surface for hip joint replacement. Benefits patient by restoring hip joint function and mobility.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Modular femoral head components; Cobalt Chromium Alloy per ASTM F1537; 36mm diameter; various offsets (-5mm, +0mm, +5mm, +10mm); intended for use with femoral stems and acetabular components in total hip arthroplasty.

Indications for Use

Indicated for patients undergoing primary or revision total hip arthroplasty requiring modular femoral head components.

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 V40™ Femoral Head Components (LFIT™ and Non-LFIT™) (K010757, K936126, K950541, K993601)

Submission Summary (Full Text)

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K022077

JUL 2 5 2002 -

Special 510(k) Summary - Addition of 36mm V40™ Femoral Heads To The LFIT™ And Non-LFIT™ Series

| | SUBJECT DEVICE | PREDICATE DEVICE |
|---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|
| Proprietary Name: | 36mm V40TM Femoral Head<br>Components (LFITTM and Non-<br>LFITTM) | 22mm-32mm V40TM Femoral Head<br>Components (LFITTM and Non-<br>LFITTM) |
| 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] | |
| Date Summary Prepared: | June 14. 2002 | |

This Special 510(k) submission is intended to add 36mm V40™ femoral head components in -5mm, +0mm, +5mm and +10mm offsets to the LFIT™ and non-LFFTTM 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 LFIT™ V40™ femoral bearing components were found substantially equivalent via the 510(k) process in K010757. The non-LFIT™ V40™ femoral head components were cleared in 510(k) numbers: K936126, K950541, and K993601. The V40™ femoral head components are fabricated from Cobalt Chromium Alloy conforming to ASTM F1537. Like the predicate devices, the subject devices are intended for use with femoral stems and acetabular components in primary or revision total hip arthroplasty.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Jennifer A. Daudelin Regulatory Affairs Howmedica Osteonics Corporation 59 Route 17 Allendale, New Jersey 07401-1677

## JUL 2 5 2002

## Re: K022077

Trade/Device Name: 36mm V40™ Femoral Head Components (LFIT™ and Non-LFIT™) Regulation Number: 21 CFR 888.3350 and 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: June 25, 2002 Received: June 26, 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.

O Mark N Milliken

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): K022077

Device Name: 36mm V40™ Femoral Heads

Indications for Use:

These devices are modular components of a total hip system. These femoral heads are intended for use with femoral stems and acetabular components in primary or revision total hip arthroplasty.

R. Mark N. Milken

ion Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K022077

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use

(Optional Format 1-2-96)