BIOLOX ALUMINA CERAMIC FEMORAL HEAD

K981847 · Smith & Nephew, Inc. · LZO · Jul 17, 1998 · Orthopedic

Device Facts

• Record ID: K981847
• Device Name: BIOLOX ALUMINA CERAMIC FEMORAL HEAD
• Applicant: Smith & Nephew, Inc.
• Product Code: LZO · Orthopedic
• Decision Date: Jul 17, 1998
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 888.3353
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Total hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma, inflammatory joint disease such as rheumatoid arthritis, or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses such as osteoarthritis; avascular necrosis; traumatic arthritis; slipped capital epiphysis; fused hip; fracture of the pelvis; diastrophic variant; old, remote osteomyelitis with an extended drainage-free period; nonunion; femoral neck fracture and trochanteric fractures of the proximal femur with heads involvement that are unmanageable using other techniques; femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity. The Biolox Alumina Ceramic Femoral Head is designed for single use only.

Device Story

Biolox Alumina Ceramic Femoral Head; manufactured from aluminum oxide (Al2O3); designed for use with titanium or cobalt-chromium alloy femoral components featuring 12/14 taper trunnions. Single-use orthopedic implant; intended for primary or revision total hip replacement surgery. Surgeon-implanted in clinical/OR setting. Provides articulating surface for hip joint; restores joint function; alleviates pain from degenerative or traumatic hip conditions. 28mm long size restricted from use with cobalt-chromium tapers.

Clinical Evidence

Bench testing only. Mechanical testing performed according to ceramic femoral head draft guidance requirements; results demonstrate equivalence to currently marketed devices and ability to withstand required loads without failure.

Technological Characteristics

Material: Aluminum oxide (Al2O3). Design: Femoral head with 12/14 taper. Compatibility: Titanium and cobalt-chromium alloy femoral components. Single-use. No software or electronic components.

Indications for Use

Indicated for individuals undergoing primary or revision total hip arthroplasty due to trauma, inflammatory joint disease (e.g., rheumatoid arthritis), or noninflammatory degenerative joint disease (e.g., osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, pelvic fracture, diastrophic variant, remote osteomyelitis, nonunion, femoral neck/trochanteric fractures, femoral osteotomy, Girdlestone resection, fracture dislocation, or deformity).

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

• Biolox Alumina Ceramic Femoral Head - Smith & Nephew
• Zirconia Ceramic Femoral Head - Smith & Nephew
• Alumina C-Taper Ceramic Femoral Head - Osteonics

Submission Summary (Full Text)

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# - JUL 17 1998

## x) Summary of Safety and Effectiveness Biolox Alumina Ceramic Femoral Head

| Submitter's name: | Smith & Nephew, Inc |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------|
| Submitter's address: | 1450 Brooks Road, Memphis, TN 38116 |
| Submitter's telephone number: | 901/396-2121 |
| Contact person: | JoAnn Kuhne |
| Date summary prepared: | June 11, 1998 |
| Trade or proprietary device name: | Biolox Alumina Ceramic Femoral Head |
| Common or unusual name: | Ceramic Femoral Head |
| Classification name: | 21 CFR 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Class II |

Biolox Alumina Ceramic Femoral Head Legally marketed predicate device:

#### Subject device description:

The Biolox Alumina Ceramic Femoral Head is manufactured from aluminum oxide, Al2O3 and is designed for use with both titanium and cobalt chromium alloy femoral components with a 12/14 taper. The 28 long size will not be marketed in the USA for use with a Co-Cr-Mo taper.

## Subject device intended use:

Total hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma, inflammatory joint disease such as rheumatoid arthritis, or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses such as osteoarthritis; avascular necrosis; traumatic arthritis; slipped capital epiphysis; fused hip; fracture of the pelvis; diastrophic variant; old, remote osteomyelitis with an extended drainage-free period; nonunion; femoral neck fracture and trochanteric fractures of the proximal femur with heads involvement that are unmanageable using other techniques; femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity.

The Biolox Alumina Ceramic Femoral Head is designed for single use only.

## Technological characteristics:

The Biolox Alumina Ceramic Femoral Head with a 12/14 taper is similar to the devices listed below.

- . Biolox Alumina Ceramic Femoral Head - Smith & Nephew
- . Zirconia Ceramic Femoral Head - Smith & Nephew
- Alumina C-Taper Ceramic Femoral Head - Osteonics

All of the devices listed above are indicated for total hip replacement and are similar in design to the Biolox Alumina Ceramic Femoral Head. The new device has the same technological characteristics as the predicate device.

#### Performance characteristics:

Mechanical testing was performed according to the requirements in the ceramic femoral head draft guidance document. All of the test results indicate that the Biolox Alumina Ceramic Femoral Head is equivalent to devices currently on the market and capable of withstanding without failure.

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Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure, composed of three curved lines that suggest the head and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 7 1998

Ms. JoAnn M. Kuhne ·Manager, Regulatory Affairs Smith & Nephew, Inc. Orthopaedic Division 1450 East Brooks Road Memphis, Tennessee 38116

Re : K981847 Biolox Alumina Ceramic Femoral Heads Requlatory Class: II Product Code: LZO Dated: May 22, 1998 Received: May 26, 1998

Dear Ms. Kuhne:

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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act and the following limitation that the package insert must reflect that the Biolox Alumina Ceramic Femoral Heads are to be used only with cobalt-chrome and Ti6Al4V alloy Smith & Nephew hip stems with the 12/14 taper trunnions, and that the 28 mm long sized femoral head is not for use with cobalt-chrome tapers.

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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that,

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Page 2 - Ms. JoAnn M. Kuhne

through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. 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 requlation (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 obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Colia M. Witton, Ph.D.

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

Enclosure

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## Indications Statement Biolox Alumina Ceramic Femoral Head

Total hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma, inflammatory joint disease such as rheumatoid arthritis, or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses such as osteoarthritis; avascular necrosis; traumatic arthritis; slipped capital epiphysis; fused hip; fracture of the pelvis; diastrophic variant; old, remote osteomyelitis with an extended drainage-free period; nonunion; femoral neck fracture and trochanteric fractures of the proximal femur with heads involvement that are unmanageable using other techniques; femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity.

Prescription Use
(Per 21 CFR 801.109)

Busola

(Division Sign-Off) Division of General Restorative Devi 510(k) Number.

Alumina Ceramic Head 510(k).doc

CONFIDENTIAL