OSTEONICS PRIMARY SECUR-FIT PLUS HIP STEMS

K990203 · Osteonics Corp. · MEH · Feb 18, 1999 · Orthopedic

Device Facts

• Record ID: K990203
• Device Name: OSTEONICS PRIMARY SECUR-FIT PLUS HIP STEMS
• Applicant: Osteonics Corp.
• Product Code: MEH · Orthopedic
• Decision Date: Feb 18, 1999
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3353
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Osteonics® Primary Secur-Fit™ Plus Hip Stems are single use components. They are intended for cementless fixation within the prepared femoral canals of patients requiring hip arthroplasty. The modified and predicate hip stems are intended to be used in conjunction with any commercially available Osteonics C-Taper femoral bearing head. For use as a total hip replacement, the modified and predicate stems may be used in conjunction with any legally marketed Osteonics acetabular component. The Osteonics® Primary Secur-Fit™ Plus Hip Stems are manufactured from titanium alloy (ASTM F-620-96). The indications for the Osteonics® Primary Secur-Fit™ Plus Hip Stems include the following: For Use as a Bipolar Hip Replacement: - Femoral head/neck fractures or non-unions. - Aseptic necrosis of the femoral head. - Osteo-, theumatoid, and post-traumatic arthritis of the hip with minimal acetabular involvement or distortion. Other Considerations: - 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 Primary Secur-Fit Plus Hip Stems are femoral components for cementless hip arthroplasty. Modification includes addition of two smaller sizes (5 and 6) and removal of distal tri-slot on 9mm/10mm diameter stems. Device functions as mechanical interlock within prepared femoral canal; used with Osteonics C-Taper femoral heads and acetabular components. Intended for surgical use by orthopedic surgeons in clinical settings. Benefits include restoration of joint function in patients with degenerative, rheumatoid, or post-traumatic hip disease. Device provides structural support for hip joint replacement.

Clinical Evidence

Bench testing only. Mechanical fatigue testing was performed to demonstrate that the modified stem design maintains substantial equivalence in fatigue strength compared to the predicate design.

Technological Characteristics

Titanium alloy (ASTM F-620-96); cementless, press-fit femoral stem; includes C-Taper interface for femoral heads; modified to include sizes 5 and 6 and remove distal tri-slot on 9mm/10mm stems.

Indications for Use

Indicated for patients requiring hip arthroplasty due to femoral head/neck fractures, non-unions, aseptic necrosis, or arthritis (osteo-, rheumatoid, post-traumatic). Also indicated for revision of failed hip procedures, salvage of failed total hip arthroplasty, or clinical scenarios where arthrodesis is less favorable. Applicable for both bipolar and total hip replacement.

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

• Osteonics® Primary Secur-Fit™ Plus Hip Stem Series (K990203)

Submission Summary (Full Text)

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2/18/99

K990203

# Special 510(k) - Device Modification Summary of Safety and Effectiveness for the Osteonics® Primary Secur-Fit™ Plus Hip Stems

# Submission Information

| Name and Address of the Sponsor<br>of the 510(k) Submission: | Osteonics Corporation<br>59 Route 17<br>Allendale, NJ 07401-1677 |
|--------------------------------------------------------------|-------------------------------------------------------------------------------|
| Contact Person: | Kate Sutton<br>Regulatory Affairs Specialist |
| Date of Summary Preparation: | January 18, 1999 |
| Device Identification | |
| Proprietary Name: | Osteonics® Primary Secur-FitTM Plus Hip<br>Stem Series |
| Common Name: | Hip Prosthesis |
| Classification Name and Reference: | Hip Joint, Metal/Ceramic/Polymer, Semi-<br>Constrained Cemented or Non-Porous |

## Predicate Device Identification

The modified features of the Osteonics® Primary Secur-Fit™ Plus Hip Stems are substantially equivalent to features of the following Osteonics predicate device, which has been cleared for marketing via the 510(k) process:

Uncemented Prosthesis 21 CFR §888.3353

- Osteonics® Primary Secur-Fit™™ Plus Hip Stem Series .
#### Device Description

The Osteonics® Primary Secur-Fit™ Plus Hip Stems are currently marketed devices that are being modified. The modification involves the addition of two smaller sizes, 5 and 6, and elimination of

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the distal tri-slot on stems with a 9mm or 10mm distal diameter. All other aspects of the Osteonics® Primary Secur-Fit™ Plus Hip Stems will remain unchanged.

## Intended Use:

The Osteonics® Primary Secur-Fit™ Plus Hip Stems are single use components. They are intended for cementless fixation within the prepared femoral canals of patients requiring hip arthroplasty. The modified and predicate hip stems are intended to be used in conjunction with any commercially available Osteonics C-Taper femoral bearing head. For use as a total hip replacement, the modified and predicate stems may be used in conjunction with any legally marketed Osteonics acetabular component. The Osteonics® Primary Secur-Fit™ Plus Hip Stems are manufactured from titanium alloy (ASTM F-620-96). The indications for the Osteonics® Primary Secur-Fit™ Plus Hip Stems include the following:

For Use as a Bipolar Hip Replacement:

- Femoral head/neck fractures or non-unions. .
- Aseptic necrosis of the femoral head.
- . Osteo-, theumatoid, and post-traumatic arthritis of the hip with minimal acetabular involvement or distortion.

Other Considerations:

- 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.

#### Performance Data:

Mechanical testing has been performed to demonstrate the substantial equivalence of this Osteonics stem design to predicate stem designs in terms of its fatigue strength.

#### Statement of Technological Comparison:

The modification involves the addition of two smaller sizes, 5 and 6, and elimination of the distal tri-slot on stems with a 9mm or 10mm distal diameter. All other aspects of the Osteonics® Primary Secur-Fit™ Plus Hip Stems will remain unchanged.

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Image /page/2/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" around the perimeter. In the center of the seal is a stylized image of three faces in profile, stacked on top of each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 8 1999

Ms. Elizabeth A. Staub Director, Quality Assurance and Requlatory Affairs Osteonics Corporation 59 Route 17 07401-1677 Allendale, New Jersey

Re : K990203 Osteonics® Primary Secur-Fit™ Plus Hip Stem Series Requlatory Class: II Product Code: MEH Dated: January 18, 1999 Received: January 21, 1999

Dear Ms. Staub:

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). This decision is based on consideration of the specific design of stem and coating composition detailed in this application. You may, therefore, market the device, subject to the general controls provisions of the Act and the following limitation:

You may not label or in any way promote these devices for "biological attachment, enhanced clinical or radiographic performance, enhanced fixation and/or long-term stable fixation." The data presented support equivalence with no additional claims over a conventional press-fit hip prosthesis (i.e., mechanical interlock, only).

Additional limitations for more specific claims of safety and effectiveness may be forthcoming. Should additional limitations be applied you will be contacted in writing to inform you of the additional labeling limitations.

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.

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Page 2 - Ms. Elizabeth A. Staub

You may market your device under the above limitations as class II devices. These devices would be considered not substantially equivalent to a legally marketed predicate device if labeled with other intended uses and/or claims of safety or effectiveness. Any other intended uses or claims may cause the device to be classified into Class III under Section 513 (f) of the Act. Class III devices are required to have an approved premarket approval (PMA) application prior to marketing.

Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to A substantially equivalent determination assumes 895. 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 and that, through periodic (QS) inspections, the Food and 820) Druq Administration (FDA) will verify such assumptions. 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 immediately. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and 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

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Page 3 - Ms. Elizabeth A. Staub

obtained from the Division of Small Manufacturers Assistance obtained from the Division of Billar [phone] or at
at its toll-free number [phone] or [phone] or at at Its Coll-Iree number (600)- 650 2011-02-100, 100 1000 1000 1000 1000 1000 1000 1000 1000 100

Sincerely yours,

a M. Witten, Ph.D., M.D. L Celi Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# 510(k) Number (if known): K_990 >0 }

Device Name: Osteonics® Primary Secur-Fit™ Plus Hip Stems

Indications For Use:

The indications for the use of the Osteonics® Primary Secur-Fit™ Plus Hip Stems , in keeping with those of other legally marketed Osteonics femoral components, are as follows:

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.

Other Considerations:

- 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.

(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 No

(Optional Format 1-2-96)

eral Restorative Device