MODIFICATION TO V-40/C-TAPER ADAPTER SLEEVE

K051737 · Howmedica Osteonics Corp. · LZO · Jul 19, 2005 · Orthopedic

Device Facts

• Record ID: K051737
• Device Name: MODIFICATION TO V-40/C-TAPER ADAPTER SLEEVE
• Applicant: Howmedica Osteonics Corp.
• Product Code: LZO · Orthopedic
• Decision Date: Jul 19, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3353
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The V40 "/C-Taper Adapter Sleeve is intended to allow either a Howmedica Osteonics C-Taper Alumina Head or a Howmedica Osteonics C-Taper Biolox® Delta Ceramic Femoral Head to mate with a Howmedica Osteonics femoral stem with a V40" taper. The V40" /C-Taper Adapter Sleeve is a single-use device.

Device Story

Tapered sleeve component; female V-40 taper locks with Howmedica Osteonics femoral stem; male exterior taper locks with C-Taper Alumina or Biolox Delta Ceramic Femoral Heads. Used in orthopedic surgery for total or bipolar hip replacement. Device facilitates modularity between femoral stems and ceramic heads. Single-use. Surgeon-operated during hip arthroplasty. Benefits patient by enabling use of specific ceramic bearing surfaces in hip reconstruction.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Tapered sleeve; female V-40 internal taper; male external C-Taper. Material: Zirconia toughened Alumina (for ceramic heads). Single-use. Mechanical locking mechanism.

Indications for Use

Indicated for total hip replacement in patients with painful disabling joint disease (degenerative, rheumatoid, post-traumatic arthritis, or late stage vascular necrosis), revision of previous cup arthroplasty, or clinical management problems where alternative techniques are less likely to succeed. Also indicated for bipolar hip replacement in patients with femoral head/neck fractures/non-unions, aseptic necrosis, or arthritis with minimal acetabular involvement. Applicable for salvage of failed total hip arthroplasty or cases requiring conservative acetabular procedures.

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.

Submission Summary (Full Text)

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Line Extension to the V40" /C-Taper Adaptor Sleeve

JUL 19 2005

K051737 p1/2

Special 510(k) Premarket Notification

# 510(k) Summary of Safety and Effectiveness Line Extension to the V-40™/C-Taper Adapter Sleeve

| Proprietary Name: | V-40™/C-Taper Adapter Sleeve |
|----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | V40™/C-Taper Adapter Sleeve |
| Proposed Regulatory Class: | Class II |
| Classification: | Hip joint metal/ceramic/polymer semi-constrained cemented or<br>nonporous uncemented prosthesis, 21 CFR §888.3353. |
| Device Product Code: | 87 LZO: Prosthesis, Hip, Semi-Constrained,<br>Metal/Ceramic/Polymer, Cemented or Non-Porous, Uncemented |
| For Information contact: | Karen Ariemma, Senior Regulatory Affairs Specialist<br>Howmedica Osteonics Corp.<br>325 Corporate Drive<br>Mahwah, NJ 07430<br>Telephone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Date Summary Prepared: | June 27, 2005 |

# Device Description

The subject V-40" /C-Taper Adapter Sleeve is a tapered sleeve component with a female V-40" taper to provide locking with a Howmedica Osteonics femoral stem with a V-40 * taper. In addition, the sleeve has a tapered male exterior surface that provides locking with Howmedica Osteonics C-Taper Alumina Ceramic Heads.

## Device Modification

This submission adds the use of a C-Taper Biolox® Delta Ceramic Femoral Head with the V-40"/C-Taper Adapter Sleeve.

## Intended Use

The V40 "/C-Taper Adapter Sleeve is intended to allow either a Howmedica Osteonics C-Taper

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K051737 p²/₂

Special 510(k) Premarket Notification

Alumina Head or a Howmedica Osteonics C-Taper Biolox® Delta Ceramic Femoral Head to mate with a Howmedica Osteonics femoral stem with a V40" taper. The V40" /C-Taper Adapter Sleeve is a single-use device.

#### Indications for Use

#### 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 vascular necrosis.
- Revision of previous cup arthroplasty or other procedures. .
- Clinical management problems where arthrodesis or alternative reconstructive techniques are . less likely to achieve satisfactory results.

#### 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 considerations 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. .

#### Substantial Equivalence

The features of the new components are substantially equivalent to the predicate devices based on similarities in intended use, materials and design. Mechanical testing demonstrates substantial equivalence of the new components to the predicate devices in regards to mechanical strength. In addition, the intended use, manufacturing methods, packaging, and sterilization of the predicate and new components are identical. The material of the subject V40"/C-Taper Adapter Sleeve remains unchanged. The subject ceramic femoral heads are fabricated from Zirconia toughened Alumina.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA

JUL 1 9 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Karen Ariemma Senior Regulatory Affairs Specialist Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, New Jersey 07432

\$\frac{1}{2}\$

Re: K051737 Trade/Device Name: V40™/C-Taper Sleeve Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Regulatory Class: II Product Code: LZO Dated: June 27, 2005 Received: June 28, 2005

Dear Ms. Ariemma:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Karen Ariemma

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis loter will and in yours of substantial equivalence of your device to a legally premaired predicated on "The station 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), please if you desire specific arrant at [phone]. Also, please note the regulation entitled, Connact the Office of County of County of Cation" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general miormation on Jour Corsumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

E. A. Th

Miriam C. Provost, Ph.D Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: V40"/C-Taper Adapter Sleeve

Indications For Use:

The indications for use of the subject device, in keeping with those of other legally marketed Howmedica Osteonics' adapter sleeves is as follows:

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## 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 vascular necrosis.
- Revision of previous cup arthroplasty or other procedures. .

- Clinical management problems where arthrodesis or alternative reconstructive techniques are . less likely to achieve satisfactory results.
## 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 considerations 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. .

Prescription Use _____________________________________________________________________________________________________________________________________________________________

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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K051737