ALUMINA V40 FEMORAL HEADS

K023901 · Howmedica Osteonics Corp. · LZO · Jan 28, 2003 · Orthopedic

Device Facts

• Record ID: K023901
• Device Name: ALUMINA V40 FEMORAL HEADS
• Applicant: Howmedica Osteonics Corp.
• Product Code: LZO · Orthopedic
• Decision Date: Jan 28, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3353
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The subject femoral head is a single-use device intended for use in total hip replacement. It is intended for use with any currently available Howmedica Osteonics acetabular component. It is intended for use with any currently available Howmedica Osteonics hip stem featuring the V40™ trunnion and manufactured from a titanium alloy or Orthinox™ Stainless Steel. It is not intended for use with any stem manufactured from cobalt chromium alloy.

Device Story

Alumina V40™ Femoral Heads are prosthetic components for total hip replacement; used in conjunction with Howmedica Osteonics acetabular components and V40™ trunnion-compatible hip stems (titanium alloy or Orthinox™ stainless steel). Device functions as a bearing surface in hip arthroplasty. Subject device features improved taper grinding technique for smoother surface finish, increasing strength compared to predicate. Intended for surgical implantation by orthopedic surgeons in hospital settings. Benefits include restoration of hip function and pain relief for patients with degenerative or traumatic joint disease.

Clinical Evidence

No clinical data provided; substantial equivalence based on design and material similarity to predicate device.

Technological Characteristics

Alumina ceramic femoral head; V40™ trunnion interface. Improved taper grinding technique for smoother surface finish. Compatible with titanium alloy or Orthinox™ stainless steel stems. Single-use, sterile, non-porous hip prosthesis.

Indications for Use

Indicated for patients with painful, disabling hip joint disease including non-inflammatory degenerative arthritis (osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, pelvic fracture, failed fracture fixation, diastrophic variant), rheumatoid arthritis, functional deformity, poor bone stock/acetabular deficiencies, nonunion/fractures of proximal femur, and revision procedures. Contraindicated for use with cobalt chromium alloy stems.

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

• Alumina V40™ Femoral Heads (K003413)

Submission Summary (Full Text)

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JAN 2 8 2003

Alumina V40™ Femoral Heads

023901
510(k) Premarket Notification

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# 510(k) Summary

### Alumina V40TM Femoral Heads

| Proprietary Name: | Alumina V40TM Femoral Heads |
|------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Artificial Hip Component |
| Classification Name and Reference: | Hip Joint,<br>Metal/Ceramic/Polymer, Semi-Constrained,<br>Cemented or Nonporous Uncemented Prosthesis,<br>21 CFR §888.3353 |
| Proposed Regulatory Class: | Class II |
| Device Product Code: | 87 LZO: Prosthesis, Hip, Semi-Constrained, Metal/<br>Ceramic /Polymer, Cemented or Non-Porous,<br>Uncemented |
| Predicate Proprietary Name: | Alumina V40TM Femoral Heads |
| Predicate Regulatory Class: | Class II |
| Predicate Product Code: | 87 LZO |
| For Information contact: | Debra Bing<br>Howmedica Osteonics Corp.<br>59 Route 17<br>Allendale, New Jersey 07401-1677<br>Phone: [phone]<br>Fax: [phone] |

# Description/Technological Comparison

The subject Alumina V40™ Femoral Heads and the predicate Alumina V40™ Femoral Heads (#K003413) are manufactured from the same materials using the same manufacturing processes. They share the same indications for use and are of nearly identical design. The subject Alumina V40™ Femoral Heads differ from the predicate Alumina V40™ Femoral Heads as follows:

- 1. An improved taper grinding technique provides a smoother taper surface finish. This smoother taper surface finish yields stronger ball heads that can now be used with Orthinox™ stainless steel stems (in addition to the titanium alloy stems previously cleared for use with the predicate femoral heads).

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing the bird's head and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 8 2003

Ms. Debra Bing Regulatory Affairs Manager Stryker Homedica Osteonics Corporation 59 Route 17 Allendale, New Jersey 07401-1677

Re: K023901

Trade Name: Alumina V40™ Femoral Heads 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: November 21, 2002 Received: November 22, 2002

Dear Ms. Bing:

We have reviewed your Section 510(k) premarket 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) 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. Debra Bing

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Sincerely yours,

Mark n Mllkerson

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

Enclosure

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# 510(k) Number (if known): KO2390 /

Device Name: Alumina V40™ Femoral Heads

The subject femoral head is a single-use device intended for use in total hip replacement. It is intended for use with any currently available Howmedica Osteonics acetabular component. It is intended for use with any currently available Howmedica Osteonics hip stem featuring the V40™ trunnion and manufactured from a titanium alloy or Orthinox™ Stainless Steel. It is not intended for use with any stem manufactured from cobalt chromium alloy.

# Indications:

- Painful, disabling joint disease of the hip resulting from: Non-inflammatory degenerative . arthritis (osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, pelvic fracture, failed fracture fixation, or diastrophic variant);
- . Rheumatoid arthritis;
- Correction of functional deformity; .
- Where bone stock is of poor quality or inadequate for other reconstructive techniques as . indicated by deficiencies of the acetabulum;
- Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with . head involvement that are unmanageable uing other techniques;
- Revision procedures where other treatments or devices have failed. .

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

OR

Over-The-Counter Use (Per 21 CFR 801.109) (Optional Format 1-2-96)

Mark A. Milken

estorative .

K023901