UNIVERSAL TAPER DELTA FEMORAL HEAD

K070885 · Howmedica Osteonics Corp. · LZO · May 16, 2007 · Orthopedic

Device Facts

• Record ID: K070885
• Device Name: UNIVERSAL TAPER DELTA FEMORAL HEAD
• Applicant: Howmedica Osteonics Corp.
• Product Code: LZO · Orthopedic
• Decision Date: May 16, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3353
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The subject devices are sterile, single use devices. The Universal Taper Biolox delta femoral heads and metal adaptor sleeves can be used with all Howmedica Osteonics C-Taper® and V-40® hip stems made from Titanium or Cobalt Chrome alloys. The stainless steel metal adaptors are can be used with all Howmedica Osteonics stainless steel stems. When used as a total hip replacement, they are intended for use only with Howmedica Osteonics polyethylene inserts.

Device Story

Universal Taper Delta Femoral Head consists of Biolox delta ceramic femoral heads (28mm-44mm) modified with metal sleeves to accommodate C-taper and V40 taper femoral stems. Device provides mechanical fixation to mating hip stems in cemented or cementless hip arthroplasty. Used by orthopedic surgeons in clinical settings. Metal sleeves available in various offsets to facilitate compatibility with Howmedica Osteonics titanium, cobalt chrome, or stainless steel stems. When used for total hip replacement, requires use with Howmedica Osteonics polyethylene inserts. Device restores hip joint function in patients with degenerative, inflammatory, or traumatic joint disease.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Biolox delta ceramic femoral heads; metal adaptor sleeves (titanium, cobalt chrome, or stainless steel); 28mm-44mm diameters; universal taper design; sterile, single-use; mechanical fixation; semi-constrained hip prosthesis.

Indications for Use

Indicated for patients requiring cemented or cementless hip arthroplasty. Bipolar indications: femoral head/neck fractures/non-unions, aseptic necrosis, arthritis (osteo-, rheumatoid, post-traumatic) with minimal acetabular involvement, conservative acetabular procedures, salvage of failed total hip arthroplasty. Total hip indications: painful disabling joint disease (degenerative/rheumatoid/post-traumatic arthritis, late-stage avascular necrosis), revision of failed procedures, clinical management where arthrodesis/reconstruction is less likely to succeed, or poor/inadequate 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.

Submission Summary (Full Text)

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K070885

MAY 16 2007

### 510(k) Summary of Safety and Effectiveness for the Universal Taper Delta Femoral Head

Proprietary Name:

Common Name:

Classification Name and Reference

Universal Taper Delta Femoral Head

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Hip Prosthesis

Hip Joint, Metal/Ceramic/Polymer, Semi-Constrained, Cemented or Nonporous Uncemented Prosthesis 21 CFR §888.3353

Regulatory Class:

Device Product Code:

Class II

87 LZO - Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non-Porous, Uncemented

87 LPH - Prosthesis Hip, Semi-Constrained, Porous Coated, Uncemented

87 MEH - Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate

87 JDI - Prosthesis, hip, semi-constrained, metal/polymer, cemented

For Information contact:

Tiffani Rogers Regulatory Affairs Specialist Stryker Orthopaedics 325 Corporate Drive Mahwah, New Jersey 07432 Phone: [phone] Fax: [phone] E-Mail: Tiffani.Rogers(@stryker.com

Date Summary Prepared:

May 11, 2007

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# K0700855

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#### Device Description

The Howmedica Osteonics Biolox delta ceramic femoral heads will now be available in a universal taper with available metal sleeves which accommodate C-taper® and V40® taper femoral stems. The modified ceramic femoral heads will be available in diameters from 28mm to 44mm. The metal sleeves will be available in a variety of offsets.

#### Intended Use:

The subject devices are sterile, single use devices. The Universal Taper Biolox delta femoral heads and metal adaptor sleeves can be used with all Howmedica Osteonics C-Taper® and V-40® hip stems made from Titanium or Cobalt Chrome alloys. The stainless steel metal adaptors are can be used with all Howmedica Osteonics stainless steel stems. When used as a total hip replacement, they are intended for use only with Howmedica Osteonics polyethylene inserts.

#### Indications for Use

The femoral heads are intended for mechanical fixation to their mating hip stems, and can be used in cemented or cementless hip arthroplasty procedures.

Indications for Use as a Bipolar

- Femoral head/neck fractures or non-unions, 미
- 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 that indicate a more conservative I acetabular procedure and an avoidance of the use of bone cement in the acetabulum,
- 트 Salvage of failed total hip arthroplasty.

Indications for Use as a Total Hip:

- Painful disabling joint disease of the hip resulting from: degenerative arthritis, I 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 в techniques are less likely to achieve satisfactory results,
- Where bone stock is of poor quality or is inadequate for other reconstructive 트 techniques as indicated by deficiencies in the acetabulum.

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

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Howmedica Osteonics Corporation % Ms. Tiffiani D. Rogers Regulatory Affairs Specialist 325 Corporate Drive Mahwah, New Jersey 07432

MAY 16 2007

Re: K070885

Trade/Device Name: Universal Taper Delta Femoral Head 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: March 29, 2007 Received: March 30, 2007

Dear Ms. Rogers:

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. Iisting 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 mav 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

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Page 2 - Ms. Tiffani Rogers

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.

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/industry/support/index.html.

Sincerely yours,

Mark N. Mello

Mark N. Melkerson 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): Ko7(2885

Device Name: Universal Taper Delta Femoral Head

#### Indications for Use

The femoral heads are intended for mechanical fixation to their mating hip stems, and can be used in cemented or cementless hip arthroplasty procedures.

Indications for Use as a Bipolar

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

Indications for Use as a Total Hip:

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

× Prescription Use

OR (Per 21 CFR 801.109)

Over-the-Counter Use

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Yaubara Suekoff

(Division Sign-Off Division of General, Restorative. and Neurological Devices

**510(k) Number** K070885