BIOLOX DELTA CERAMIC FEMORAL HEADS

K051588 · Howmedica Osteonics Corp. · LZO · Jul 12, 2005 · Orthopedic

Device Facts

• Record ID: K051588
• Device Name: BIOLOX DELTA CERAMIC FEMORAL HEADS
• Applicant: Howmedica Osteonics Corp.
• Product Code: LZO · Orthopedic
• Decision Date: Jul 12, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3353
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The subject devices are single use devices. They are intended for mechanical fixation to their mating hip stems, and can be used in cemented or cementless hip arthroplasty procedures. They can be used with all Howmedica Osteonics C-Taper* hip stems made from Titanium or CoCr alloys. When used as a total hip replacement, they are intended for use only with Howmedica Osteonics polyethylenc bearing surfaces. Indications for Use as a Bipolar - 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 that indicate a more conscrvative acetabular . 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 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, - Where bone stock is of poor quality or is inadequate for other reconstructive techniques . as indicated by deficiencies in the acetabulum.

Device Story

Biolox® Delta Ceramic Femoral Heads are orthopedic components for hip arthroplasty; designed to mate with Howmedica Osteonics C-Taper femoral stems (Titanium or CoCr alloys). Device serves as the articulating head in total hip or bipolar hip replacement. Used in clinical settings by orthopedic surgeons. Mechanical fixation to femoral stem; provides bearing surface for hip joint movement. Benefits include restoration of joint function and pain relief in patients with degenerative or traumatic hip disease. Line extension adds specific 36 mm diameter head sizes and compatibility with Trident® X3™ Acetabular inserts.

Clinical Evidence

Bench testing only. No clinical data provided. Mechanical testing demonstrated substantial equivalence in strength to predicate devices.

Technological Characteristics

Biolox® Delta ceramic femoral heads; 28, 32, and 36 mm diameters; various neck offsets. Mates with Titanium or CoCr alloy C-Taper femoral stems. Designed for cemented or cementless hip arthroplasty. Compatible with polyethylene bearing surfaces.

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 salvage of failed total hip arthroplasty, revision of previous procedures, or cases where bone stock is inadequate for other techniques. Applicable for both bipolar and total hip replacement configurations.

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

• C-Taper hip stems (K982032)

Submission Summary (Full Text)

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Line Extension to the Biolox® Delta Ceramic Femoral Heads

K05/588

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# JUL 1 2 2005 510(k) Summary of Safety and Effectiveness

## Line Extension to the Biolox® Delta Ceramic Femoral Heads

| Proprietary Name: | Biolox® Delta Ceramic Femoral Heads |
|----------------------------|--------------------------------------------------------------|
| Common Name: | Artificial femoral head component |
| Proposed Regulatory Class: | Class II |
| Classification: | Hip joint metal/ceramic/polymer semi-constrained cemented or |
| | nonporous uncemented prosthesis, 21 CFR §888.3353. |
| Device Product Code: | 87 LZO: Prosthesis, Hip, Semi-Constrained, |
| | Metal/Ceramic/Polymer, Cemented or Non-Porous, Uncemented |
| For Information contact: | Karen Ariemma, Senior Regulatory Affairs Specialist |
| | Howmedica Osteonics Corp. |
| | 325 Corporate Drive |
| | Mahwah, NJ 07430 |
| | Telephone: [phone] |
| | Fax: [phone] |
| | Email: [e-mail] |
| Date Summary Prepared: | June 13, 2005 |

#### Device Description

The subject Biolox® Delta Ceramic Femoral Heads mate with Howmedica Osteonics` C-Taper femoral stems fabricated from Titanium or CoCr alloys. The Biolox® Delta Ceramic Femoral Heads are available in 28, 32 and 36 mm diameters and a variety of neck offsets.

### Device Modification

This submission adds additional femoral heads (36 mm diameter -5.0 mm offset heads and 36 mm diameter +7.5 mm offset heads) and allows for use of the Biolox® Delta Ceramic Femoral Heads with the Trident® X3™ Acetabular inserts.

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Line Extension to the Biolox® Delta Ceramic Femoral Heads

21

## Indications for Use

The subject devices are single use devices. They are intended for mechanical fixation to their mating hip stems, and can be used in cemented or cementless hip arthroplasty procedures. They can be used with all Howmedica Osteonics C-Taper* hip stems made from Titanium or CoCr alloys. When used as a total hip replacement, they are intended for use only with Howmedica Osteonics polyethylenc bearing surfaces.

Indications for Use as a Bipolar

- 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 that indicate a more conscrvative acetabular . 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 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,
- Where bone stock is of poor quality or is inadequate for other reconstructive techniques . as indicated by deficiencies in the acetabulum.

* The term "C-Taper" includes both the original C-Taper design, and the modified C-Taper design first introduced on the hip stems found Substantially Equivalent via K982032.

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88

#### 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, material, manufacturing methods, packaging, and sterilization of the predicate and new components are identical.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The logo is surrounded by a circular border containing the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" in capital letters.

JUL 1 2 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Karen Ariemma Senior Regulatory Affairs Specialist Stryker Howmedica Osteonics 325 Corporate Drive Mahwah, New Jersey 07430

Received: June 15, 2005

Re: K051588

Trode/Device Name: Line Extension to Biolox® Delta Ceramic Femoral Heads Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Regulatory Class: Class II Product Code: LZO Dated: June 13, 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) 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,

Erle M

Miriam 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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510(k) Number (if known):

Device Name: Biolox® Delta Ceramic Femoral Heads

The subject devices are single use devices. They are intended for mcchanical fixation to their mating hip stems, and can be used in cementless hip arthroplasty procedures. They can be used with all Howmedica Osteonics C-Taper* hip stems made from Titanium or CoCr alloys. When used as a total hip replacement, they are intended for use only with Howmedica Osteonics polyethylene bearing surfaces.

Indications for Use as a Bipolar

- Femoral head/neck fractures or non-unions, ■
- 트 Aseptic necrosis of the femoral head,
- 트 Osteo-, rheumatoid, and post traumatic arthritis of the hip with minimal acetabular involvement or distortion.
- b Pathological conditions or age considerations that indicate a more conservative acetabular 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 discase of the hip resulting from: degenerative arthritis, rheumatoid 미 arthritis, post-traumatic arthritis or late stage avascular necrosis,
- · Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure,
- i 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 in the acctabulum.

* The term "C-Taper" includes both the original C-Taper design, and the modified C-Taper design first introduced on the hip stems found Substantially Equivalent via K982032

Prescription Use X - -AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use

(21 CFR 807 Subpart C)

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

Ola

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Civision Sin -Off Division of Conneral, Restorative and Neurolo, Joal Devices

051588