PRECISION OSTEOLOCK FEMORAL STEMS WITH PURE-FIX HA COATING

K992025 · Howmedica Osteonics Corp. · MEH · Aug 13, 1999 · Orthopedic

Device Facts

• Record ID: K992025
• Device Name: PRECISION OSTEOLOCK FEMORAL STEMS WITH PURE-FIX HA COATING
• Applicant: Howmedica Osteonics Corp.
• Product Code: MEH · Orthopedic
• Decision Date: Aug 13, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3353
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

This stem is intended to be used for primary or secondary reconstruction of the head and neck of the femur when sufficient, good quality bone stock is present. Use of this device is indicated for reconstruction of painful and/or severely disabled hip joints resulting from osteoarthritis, rheumatiod arthritis, post traumatic arthritis, avascular necrosis, subcaptital fracture, or in revision of a failed femoral prosthesis. This femoral stem is intended to be used with Howmedica Osteonics femoral heads with a 2° 52' taper. The femoral stem can be used with Howmedica Osteonics bipolar or unipolar devices as an endoprosthesis, or can articulate with a Howmedica Osteonics acetabular cup prosthesis in total hip arthroplasty procedures. The Precision® Osteolock Femoral Component with Pure-Fix™ HA Coating is designed to be used in a simple cementless press-fit mode.

Device Story

Precision® Osteolock Femoral Stem is a titanium femoral component for hip arthroplasty; features Pure-Fix™ hydroxyapatite (HA) coating. Device functions as a cementless press-fit implant; articulates with Howmedica Osteonics femoral heads (2° 52' taper), bipolar/unipolar devices, or acetabular cups. Used by orthopedic surgeons in clinical settings for hip reconstruction. Modification from previous version (K912395) involves replacing Low Pressure Plasma Spray (LPPS) HA coating with Pure-Fix™ HA coating. Pure-Fix™ coating previously cleared in K896047. Device provides structural support and biological fixation for patients with degenerative or traumatic hip joint conditions.

Clinical Evidence

No clinical data provided; substantial equivalence based on design similarity and established performance of the coating material.

Technological Characteristics

Titanium femoral stem; cementless press-fit design; Pure-Fix™ hydroxyapatite (HA) coating. Compatible with 2° 52' taper femoral heads. No software or electronic components.

Indications for Use

Indicated for patients requiring primary or secondary reconstruction of the femoral head and neck due to osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, avascular necrosis, subcapital fracture, or revision of a failed femoral prosthesis, provided sufficient bone stock exists.

Regulatory Classification

Identification

A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.

Predicate Devices

• Precision® Osteolock Femoral Stems with Hydroxyapatite Coating (K912395)
• Osteonics® Omnifit® EPF Femoral Prosthesis (K896047)

Submission Summary (Full Text)

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K99 2025

AUG 13 1999

510(k) Summary

Proprietary Name:

Common Name:

Classification Name and Reference:

Proposed Requlatory Class:

Device Product Code:

For information contact:

Precision® Osteolock Femoral Stems with Pure-Fix™ HA Coating

Press-Fit Titanium Femoral Stem

Prosthesis. Hip. Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calcium-Phosphate

Class II

MEH

Marybeth Naughton Requlatory Affairs Howmedica Osteonics Corp. 59 Route 17 South Allendale, New Jersey 07401 Telephone: [phone] [phone] Fax: Date Summary Prepared: 5-21-99

The purpose of this premarket notification is to describe a modification to the Precision® Osteolock Femoral Stems with Hydroxyapatite Coating (previously determined substantially equivalent via 510(k) K912395). It is the intention of Howmedica Osteonics to change the hydroxyapatite coating on these femoral stems from the Low Pressure Plasma Spray (LPPS) HA coating described in K912395 to Howmedica Osteonics Pure-Fix™ HA coating. The Pure-Fix™ HA coating was originally determined substantially equivalent on the Osteonics® Omnifit® EPF Femoral Prosthesis in premarket notification K896047. This coating has been cleared for marketing on several other Osteonics® hip prostheses.

There is no change in intended use for the Precision® Osteolock Femoral Component with Pure-Fix™ HA Coating. This stem is intended to be used for primary or secondary reconstruction of the head and neck of the femur when sufficient, good quality bone stock is present. Use of this device is indicated for reconstruction of painful and/or severely disabled hip joints resulting from osteoarthritis, rheumatiod arthritis, post traumatic arthritis, avascular necrosis, subcaptital fracture, or in revision of a failed femoral prosthesis.

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This femoral stem is intended to be used with Howmedica Osteonics femoral heads with a 2° 52' taper. The femoral stem can be used with Howmedica Osteonics bipolar or unipolar devices as an endoprosthesis, or can articulate with a Howmedica Osteonics acetabular cup prosthesis in total hip arthroplasty procedures.

The Precision® Osteolock Femoral Component with Pure-Fix™ HA Coating is designed to be used in a simple cementless press-fit mode.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the eagle. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1-3 1999

Ms. Marybeth Naughton Regulatory Affairs Howmedica Osteonics, Corp. 59 Route 17 Allendale, New Jersey 07401-1677

Re: K992025

Trade Name: Precision® Osteolock Femoral Component with Pure-Fix™ HA Coating Regulatory Class: II Product Code: MEH Dated: June 15, 1999 Received: June 16, 1999

Dear Ms. Naughton:

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 control provisions of the Act. The general control 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. A 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 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.

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.

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## Page 2 -- Ms. Marybeth Naughton

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 at [phone], or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Cail M. Wilson, Ph.D., M.D.

V 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):

Precision® Osteolock Femoral Stems with Pure-Fix™ HA Coating Device Name:

Indications for Use:

This stem is intended to be used for primary or secondary reconstruction of the head and neck of the femur when sufficient, good quality bone stock is present. Use of this device is indicated for reconstruction of painful and/or severely disabled hip joints resulting from osteoarthritis, rheumatiod arthritis, post traumatic arthritis, avascular necrosis, subcaptital fracture, or in revision of a failed femoral prosthesis.

This femoral stem is intended to be used with Howmedica Osteonics femoral heads with a 2° 52' taper. The femoral stem can be used with Howmedica Osteonics bipolar or unipolar devices as an endoprosthesis, or can articulate with a Howmedica Osteonics acetabular cup prosthesis in total hip arthroplasty procedures.

The Precision® Osteolock Femoral Component with Pure-Fix™ HA Coating is designed to be used in a simple cementless press-fit mode.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
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Over-The-Counter Use

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