OSTEONICS HA-COATED DEVICES

K980070 · Osteonics Corp. · MEH · Jul 23, 1999 · Orthopedic

Device Facts

• Record ID: K980070
• Device Name: OSTEONICS HA-COATED DEVICES
• Applicant: Osteonics Corp.
• Product Code: MEH · Orthopedic
• Decision Date: Jul 23, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3353
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Osteonics® HA-AD Coated Devices are single-use, acetabular of femoral hip implant devices intended for cementless applications. The following indications for use are consistent with previous submissions for these acetabular and femoral components intended for cementless application. Indications for Osteonics® HA-AD Acetabular Components - Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis. - Revision of previous failed femoral head replacement, cup arthroplasty or other procedure. - Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results. - Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum. Indications for Osteonics® HA-AD Femoral Components For use as a Bipolar Hip Replacement : - Femoral head/neck fractures or non-unions. - Aseptic necrosis of the femoral head. - Osteo-, rheumatoid, and post-traumatic arthritis of the hip with minimal acetabular involvement or distortion. - Pathological conditions or age considerations which indicate a more conservative acetabular procedure and an avoidance of the use of bone cement in the acetabulum. - Salvage of failed total hip arthroplasty. For use as a Total Hip Replacement: - Painful, disabling joint disease of the hip resulting from: degenerative arthritis. rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis. - Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure. - Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.

Device Story

Osteonics HA-AD Coated Devices are cementless hip implant components (acetabular and femoral) featuring a Hydroxylapatite/Arc-Deposited (HA-AD) coating. The device is intended for surgical implantation by orthopedic surgeons to replace diseased or damaged hip joints. The HA-AD coating is designed to enhance osseointegration by increasing bone apposition and bone penetration into the implant surface. The device is used in clinical settings for total or bipolar hip arthroplasty. The clinical benefit is improved fixation and bony response compared to non-HA coated implants, potentially leading to better long-term stability of the prosthesis.

Clinical Evidence

No human clinical data provided. Evidence consists of preclinical animal model studies (canine hip implantable chamber models) demonstrating that HA-AD coating increases bone apposition, linear bone contact, and bone penetration compared to arc-deposited (AD) only coatings. Bony response observed as early as 6 weeks post-implantation.

Technological Characteristics

Cementless hip implant components (acetabular and femoral) featuring a Hydroxylapatite/Arc-Deposited (HA-AD) coating. Designed for cementless application. No changes to materials or design from previously cleared versions.

Indications for Use

Indicated for patients with painful, disabling hip joint disease (degenerative, rheumatoid, post-traumatic arthritis, avascular necrosis), femoral head/neck fractures, non-unions, or failed previous hip procedures (total hip, femoral head replacement, cup arthroplasty). Suitable for patients requiring conservative acetabular procedures or those with poor bone stock.

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.

Reference Devices

• Agins HJ et al., Trans, AAOS, 1997
• Hawkins M, Ricci JL, Hydroxylapatite Coated Hip and Knee Arthroplasty, 1995
• Walenciak MT et al., J. Biomed. Mater. Res. 31 (4):465-474, 1996

Submission Summary (Full Text)

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HOWMEDICA/OSTEONICS

201 934 4368 P.05/07

JUL 2 3 1999

K980076

510(k) Summary

Osteonics HA-Coated Devices

# 510(k) Premarket Notification Summary of Safety and Effectiveness for the Osteonics® HA-AD Coated Devices

# Submission Information

| Name and Address of the Sponsor of the 510(k) Submission: | Howmedica Osteonics Corp.<br>59 Route 17<br>Allendale, NJ 07401-1677 |
|-----------------------------------------------------------|----------------------------------------------------------------------|
| Contact Person: | Marybeth Naughton<br>Regulatory Affairs Team Member |
| Date of Summary Preparation: | July 14, 1999 |

**Device Identification**

| Proprietary Name: | Osteonics HA-AD Coated Devices |
|------------------------------------|--------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Artificial hip implant components |
| Classification Name and Reference: | Hip joint metal/ceramic/polymer<br>semi-constrained cemented or non-<br>porous uncemented prosthesis<br>21 CFR §888.3353 |

### Predicate Device Identification

The subject Osteonics HA-AD Coated devices have already been determined substantially equivalent. This 510(k) involves only the addition of specific claims related to the performance of Osteonics' HA-AD coating.

#### Device Description

The devices which are the subject of this 510(k) are commercially-available Osteonics hip

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# Osteonics HA-Coated Devices

#### 510(k) Summary

acetabular and hip femoral components featuring Osteonics' HA-AD coating.

# Intended Use

.

All devices covered by this submission are single-use, acetabular or femoral hip implant devices intended for cementless applications.

## Indications for Osteonics® HA-AD Acetabular Components

- Painful, disabling joint disease of the hip resulting from: degenerative arthritis, . rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis.
- Revision of previous failed femoral head replacement, cup arthroplasty or other . procedure.
- Clinical management problems where arthrodesis or alternative reconstructive . techniques are less likely to achieve satisfactory results.
- Where bone stock is of poor quality or is inadequate for other reconstructive techniques ● as indicated by deficiencies of the acetabulum.

# Indications for Osteonics® HA-AD Femoral Components

## For use as a Bipolar Hip Replacement :

- Femoral head/neck fractures or non-unions. .
- . Aseptic necrosis of the femoral head.
- Osteo-, rheumatoid, and post-traumatic arthritis of the hip with minimal acetabular . involvement or distortion.
- Pathological conditions or age considerations which indicate a more conservative . acetabular procedure and an avoidance of the use of bone cement in the acetabulum.
- Salvage of failed total hip arthroplasty.

# For use as a Total Hip Replacement:

- Painful, disabling joint disease of the hip resulting from: degenerative arthritis, . rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis.
- Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other ● procedure.
- Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.

## Statement of Technological Comparison

Each device which is subject to this 510(k) has already been determined Substantially Equivalent for its labeled indications. This 510(k) involves no change in design, intended use, indications for use, or materials. The sole purpose of this 510(k) is to obtain FDA's permission to discuss specific performance attributes of Osteonics' HA-AD Coating.

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Osteonics HA-Coated Devices

510(k) Summary

#### Performance Data

Reports of published literature were presented within this 510(k) to demonstrate additional performance claims for Howmedica Osteonics' HA-AD Coatings. The following points relevant to the performance of Osteonics' HA-AD Coating have been demonstrated in the referenced literature reports:

Howmedica Osteonics' HA/AD (Hydroxylapatite/Arc-Deposited) Coating increases bone apposition (Ref. 1), linear bone contact (Ref. 3) and the degree of bone peneration into implantable chambers (Ref. 2) as compared to AD coated samples as demonstrated in the animal models *. The above increased bony response for HA/AD coated implants may be evidenced as early as 6 weeks after implantation.

* Animal data may not predict human clinical results because of inter-species differences.

#### References:

- Agins HJ, BauerTW, Kudrna JC, Cannestra V, Ming J. Cortical Remodeling and Bone Apposition t a レ Textured Canine Hip Implant with and without Hydroxylapatite. Trans, AAOS, February 1997.
- と Hawkins M, Ricci JL. Arc Deposited CP Titanium with and without Hydroxyapatite Coating. Preclinical Evaluation Using the Canine Implantable Chamber Model. Hydroxylapatite Coated Hip and Knee Arthroplasty ed: JA Epinette and RGT Geesink, Pp 90-95, Expansion Scientifique Francaise, 1995.
- ► Walenciak MT, Zimmerman MC, Harten RD, Ricci JL, Stamer DT. Biomechanical and Histological Analysis of an HA-Coated, Arc Deposited CPTi Canine Hip Prosthesis. J. Biomed. Mater. Res. 31 (4):465-474, 1996.

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Image /page/3/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the seal is a stylized image of a bird or eagle.

Public Health Service

JUL 23 1999

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K980070

Trade Name: Osteonics HA-Coated Devices Regulatory Class: II Product Code: MEH Dated: July 2, 1999 Received: July 6, 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 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. 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]. Furthermore, for questions regarding 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,

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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Page 1 of 2

510(k) Number (if Known): K980070

Device Name: Osteonics® HA-AD Coated Devices

#### Indications For Use:

The Osteonics® HA-AD Coated Devices are single-use, acetabular of femoral hip implant devices intended for cementless applications. The following indications for use are consistent with previous submissions for these acetabular and femoral components intended for cementless application.

### Indications for Osteonics® HA-AD Acetabular Components

- Painful, disabling joint disease of the hip resulting from: degenerative arthritis, ● rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis.
- Revision of previous failed femoral head replacement, cup arthroplasty or other procedure.
- . Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
- Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum.

## Indications for Osteonics® HA-AD Femoral Components

#### For use as a Bipolar Hip Replacement :

- . Femoral head/neck fractures or non-unions.
- Aseptic necrosis of the femoral head.
- Osteo-, rheumatoid, and post-traumatic arthritis of the hip with minimal acetabular involvement or distortion.
- Pathological conditions or age considerations which indicate a more conservative acetabular procedure and an avoidance of the use of bone cement in the acetabulum.
- . Salvage of failed total hip arthroplasty.

#### For use as a Total Hip Replacement:

- Painful, disabling joint disease of the hip resulting from: degenerative arthritis. rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis.
- Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
- . Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.

Prescription Use
(Per 21 CFR 801.109)

esults.

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### Concurrence of CDRH, Office of Device Evaluation (ODE)

Pcolle

(Division Sign-Off) Division of General Restorative De K9800 510(k) Number

y /2 OROver-The-Counter Use _(per21CFR 801.109(Optional Prescription Use_ NO Format 1-2-96)