RELIANCE LONG STEM FEMORAL COMPONENTS

K980813 · Howmedica, Inc. · JDI · Jun 26, 1998 · Orthopedic

Device Facts

• Record ID: K980813
• Device Name: RELIANCE LONG STEM FEMORAL COMPONENTS
• Applicant: Howmedica, Inc.
• Product Code: JDI · Orthopedic
• Decision Date: Jun 26, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3350
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Reliance Long Stem Femoral components are intended to be used in primary or revision surgery for patients diagnosed with rheumatoid arthritis, osteoarthritis, avascular necrosis, metastatic lesions, or traumatic femoral fractures. These femoral components are intended to be used with Howmedica's V40™ femoral heads, Unipolar or Bipolar components, and acetabular components.

Device Story

Reliance Long Stem Femoral Components are orthopedic implants designed for primary or revision hip arthroplasty. Fabricated from Cobalt-Chromium-Molybdenum (Vitallium) alloy; intended for use in surgical settings by orthopedic surgeons. The device serves as a femoral stem component in a total hip system, articulating with compatible V40 femoral heads and acetabular components to restore joint function. Clinical benefit includes stabilization and restoration of mobility in patients suffering from degenerative joint disease, necrosis, or fractures. The device is implanted during surgical procedures; no software or electronic components are involved.

Clinical Evidence

Bench testing only. Fatigue load carrying capacity testing demonstrated that the device exceeds minimum ISO load requirements.

Technological Characteristics

Material: Cobalt-Chromium-Molybdenum (Vitallium) alloy meeting ASTM F 799. Form factor: Long stem femoral component for hip arthroplasty. Energy source: None (mechanical implant). Connectivity: None. Sterilization: Not specified.

Indications for Use

Indicated for primary or revision hip surgery in patients with rheumatoid arthritis, osteoarthritis, avascular necrosis, metastatic lesions, or traumatic femoral fractures. Used with compatible V40 femoral heads, unipolar/bipolar components, and acetabular 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

• Reliance Total Hip system (K936126)
• Partnership Revision Femoral Components (K972893)
• Modular Replacement System (K952970)

Submission Summary (Full Text)

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JUN 2 6 1998

R980813

## 510(k) Summary

Proprietary Name: Reliance® Long Stem Femoral Components

Common Name: Hip Prosthesis

21 CFR 888.3353 Classification Name and Reference: Hip Joint Metal/Ceramic/Polymer semi-constrained cemented or nonporous uncemented prosthesis.

Proposed Regulatory Class: Class II

Device Product Code: LZO

For information contact: Frank Maas Manager, Regulatory Affairs Howmedica Inc. 359 Veterans Boulevard Rutherford, NJ 07070 Telephone: [phone] Fax: [phone] Date Summary Prepared: 3-3-98

The Reliance® Long Stem Femoral Components consist of a family of Cobalt-Chromium-Molybdenum (Vitallium) femoral stems. These femoral components are intended to be used in primary or revision surgery for patients diagnosed with rheumatoid arthritis, osteoarthritis, avascular necrosis, metastatic lesions, or traumatic femoral fractures. These femoral components are intended to be used with Howmedica's V40™ femoral heads. Unipolar or Bipolar components, and acetabular components.

These femoral components are manufactured from Cobalt-Chromium-Molybdenum (Vitallium) alloy, which meets the requirements of ASTM specification F 799.

The substantial equivalence of the Reliance® Long Stem Femoral components is based on an equivalence in intended use, materials, design, and relative indications and contraindications to Howmedica's Reliance® Total Hip system (K936126), Partnership Revision Femoral Components (K972893) and Modular Replacement System (K952970).

Testing has demonstrated that the fatigue load carrying capacity of the Reliance® Long Stem Femoral Components exceeds the minimum ISO load requirements.

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Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three stripes forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 26 1998

Mr. Frank Maas 'Manager, Regulatory Affairs Howmedica Inc. Pfizer Hospital Products Group 359 Veterans Boulevard Rutherford, New Jersey 07070-2584

K980813 Re: Reliance Long Stem Femoral Components Trade Name: Regulatory Class: II Product Code: JDI Dated: May 29, 1998 June 2, 1998 Received:

Dear Mr. Maas:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ದ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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## Page 2 - Mr. Frank Maas

This letter will allow you to begin marketing your device as described in your 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 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 ene regarderon choroned) 1125Randing mj Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

-Celia M. Witten, Ph.D., M.D.

Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): K980813

Device Name: Reliance Long Stem Femoral Components

Indications for Use:

The Reliance Long Stem Femoral components are intended to be used in primary or revision surgery for patients diagnosed with rheumatoid arthritis, osteoarthritis, revision surgery for pationis lesions, or traumatic femoral fractures. These avascular norooto, motablances to be used with Howmedica's V40™ femoral femoral components, and acetabular components, and acetabular components.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use_

signature

(Optional Format 1-2-96

**(Division Sign-Off)**
Division of General Restorative Devices
510(k) Number K980813

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