DISTAL CENTRALIZER, EXETER II HIP SYSTEM

K974054 · Howmedica, Inc. · JDI · Dec 23, 1997 · Orthopedic

Device Facts

• Record ID: K974054
• Device Name: DISTAL CENTRALIZER, EXETER II HIP SYSTEM
• Applicant: Howmedica, Inc.
• Product Code: JDI · Orthopedic
• Decision Date: Dec 23, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3350
• Device Class: Class 2

Intended Use

The Exeter II Distal Centralizer is intended to be used to centralize the femoral stem within the intramedullary canal. The Distal Centralizer is intended to be used with bone cement.

Device Story

Distal Centralizer, Exeter II Hip System is a molded acrylic device designed to centralize femoral hip stems within the femoral canal. Device features three wing-like projections extending from the base to contact canal walls. Used by surgeons during hip arthroplasty procedures; device is fitted to the distal portion of the hip stem prior to insertion with bone cement. Provides mechanical stabilization of the stem within the canal to ensure proper alignment.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design and material characteristics.

Technological Characteristics

Molded acrylic device; three-wing projection design; mechanical centralization principle; non-electronic; non-implantable (accessory to hip stem); intended for use with bone cement.

Indications for Use

Indicated for use in patients undergoing hip arthroplasty requiring centralization of the femoral stem within the intramedullary canal using bone cement.

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

• Definition Hip System centralizer (K936127)
• Exeter II Distal Centralizer (K891445)

Submission Summary (Full Text)

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510(k) Summary

DEC 23 1997

K974054

Proprietary Name: Distal Centralizer, Exeter II Hip System

Common Name: Centralizer, Hip Stem

Classification Name and Reference: 21 CFR 888.3350 Prosthesis, Hip, Semi-Constrained, Metal/Polymer

Proposed Regulatory Class: Class II

Device Product Code: JDI

For information contact: Frank Maas Manager, Regulatory Affairs Howmedica Inc. 359 Veterans Boulevard Rutherford, NJ 07070 Telephone: [phone] [phone] Fax: Date Summary Prepared: 10-24-97

The Exeter II Distal Centralizer is a molded acrylic device that is fitted to the distal portion of a hip stem and used to centralize the stem within the femoral canal.

The centralizer's design consists of three wing-like projections that extend outwards from the base of the centralizer. These projections contact the walls of the femoral canal, centralizing the hip stem within the canal.

The substantial equivalence of the centralizer is based on an equivalence in intended use, design, materials, operational principles, and relative indications and contraindications to Howmedica's currently marketed centralizers. These include the Definition Hip System centralizer (K 936127), and the currently marketed Exeter II Distal Centralizer (K 891445).

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 3 1997

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

K974054 Re: Trade Name: Distal Centralizer, Exeter II Hip System Regulatory Class: II Product Code: JDI Dated: October 24, 1997 Received: October 27, 1997

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 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 (Premarket Approval), 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 895. ಗಿ 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 requlatory action. In addition, FDA may publish further announcements 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
premarket notification" (21 CFR 807.97). 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. Whitten, Ph

elia 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): K974054

Device Name: Distal Centralizer, Exeter II Stem

Indications for Use:

The Exeter II Distal Centralizer is intended to be used to centralize the femoral stem within the intramedullary canal. The Distal Centralizer is intended to be used with bone cement.

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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)

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