CONSENSUS HIP SYSTEM, UNISYN HIP SYSTEM

K030151 · Hayes Medical, Inc. · LZO · Apr 10, 2003 · Orthopedic

Device Facts

• Record ID: K030151
• Device Name: CONSENSUS HIP SYSTEM, UNISYN HIP SYSTEM
• Applicant: Hayes Medical, Inc.
• Product Code: LZO · Orthopedic
• Decision Date: Apr 10, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3353
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The 32 mm ceramic femoral head is design for use with the Consensus® or UniSyn ® Hip Systems, and is not intended for substitution with components of other systems. The indications for use are: With Consensus® System: 1. Primary intervention of rheumatoid arthritis, osteoarthritis, post traumatic arthritis or degenerative arthritis, and avascular necrosis with a non-acute fracture of the femoral neck. Osteoarthrosis involving femoral and acetabular articular surfaces. 2. Avascular osteonecrosis and/or non-union of acute femoral neck fractures. 3. Fracture or dislocation of the hip. 4. Replacement of unsatisfactory cemented or press fit hip components if sufficient bone stock exists. With UniSyn® System: 1. Significantly impaired joints resulting from rheumatoid, osteo, and post-traumatic arthritis. 2. Revision of failed femoral head replacement, hip arthroplasty or other hip procedures. Proximal femoral fractures. 4. Avascular necrosis of the femoral head. Non-union of proximal femoral neck fractures. 5. Other indications such as congenital dysplasia, arthrodesis conversion, coxa magna, coxa plana, coxa vara, coxa valga, developmental conditions, metabolic and tumorous conditions, osteomalacia, pseudarthrosis conversion, and structural abnormalities. 7. Indications for the use of the UniSyn Hip System must be carefully considered with respect to the patient's entire evaluation and alternative procedures. Patient selection is dependent on age, general health, available bone stock and quality, and any prior surgery or anticipated future surgery. Prosthetic replacement is generally indicated only for patients who have reached skeletal maturity. Total joint replacement in younger patients should be considered only when explicit indications outweigh the associated risks of the surgery and modified demands regarding activity and joint loading are assured. This includes all patients who may or may not have multiple joint involvement, for whom restoration of joint mobility leads to an expectation of greater mobility and an improvement in the quality of life.

Device Story

32 mm Zirconia ceramic femoral head component; designed for integration with Consensus or UniSyn hip systems. Functions as prosthetic replacement for femoral head in total hip arthroplasty. Used by orthopedic surgeons in clinical/surgical settings. Provides articulating surface for hip joint restoration; improves mobility and quality of life in patients with degenerative or traumatic joint conditions. Not intended for use with other systems.

Clinical Evidence

No clinical data provided; substantial equivalence based on bench testing and design characteristics.

Technological Characteristics

32 mm diameter femoral head; material: Zirconia ceramic; intended for use with Consensus or UniSyn hip systems; Class II device (21 CFR 888.3353); product code LZO.

Indications for Use

Indicated for skeletally mature patients requiring hip arthroplasty due to rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, degenerative arthritis, avascular necrosis, femoral neck fractures, hip dislocation, or revision of failed prior hip procedures. Contraindicated in patients without sufficient bone stock or those unable to meet modified activity/loading demands.

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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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 0 2003

Mr. William J. Griffin QS & RA Manager Hayes Medical, Inc. 1115 Windfield Way, Suite 100 El Dorado Hills, CA 95762

Re: K030151

Trade/Device Name: 32 mm Zirconia Ceramic Femoral Head for Consensus® or UniSyn® System 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: January 8, 2003 Received: January 15, 2003

Dear Mr. Griffin:

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 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 - Mr. William J. Griffin

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 may be obtained 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,

Marl McMillan

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) 32 mm Zirconia Femoral Head

Ko 30/5/

## Section 8 Statement of Indications for Use

The 32 mm ceramic femoral head is design for use with the Consensus® or UniSyn ® Hip Systems, and is not intended for substitution with components of other systems. The indications for use are:

## With Consensus® System:

- 1. Primary intervention of rheumatoid arthritis, osteoarthritis, post traumatic arthritis or degenerative arthritis, and avascular necrosis with a non-acute fracture of the femoral neck.
- Osteoarthrosis involving femoral and acetabular articular surfaces. 2.
- Avascular osteonecrosis and/or non-union of acute femoral neck fractures. 3.
- Fracture or dislocation of the hip. 4.
- Replacement of unsatisfactory cemented or press fit hip components if sufficient ട്. bone stock exists.

## With UniSyn® System:

- 1. Significantly impaired joints resulting from rheumatoid, osteo, and post-traumatic arthritis.
- 2. Revision of failed femoral head replacement, hip arthroplasty or other hip procedures.
- Proximal femoral fractures. ဒေ
- 4. Avascular necrosis of the femoral head.
- Non-union of proximal femoral neck fractures. 5.
- Other indications such as congenital dysplasia, arthrodesis conversion, coxa magna, 6. coxa plana, coxa vara, coxa valga, developmental conditions, metabolic and tumorous conditions, osteomalacia, pseudarthrosis conversion, and structural abnormalities.
- 7. Indications for the use of the UniSyn Hip System must be carefully considered with respect to the patient's entire evaluation and alternative procedures. Patient selection is dependent on age, general health, available bone stock and quality, and any prior surgery or anticipated future surgery. Prosthetic replacement is generally indicated only for patients who have reached skeletal maturity. Total joint replacement in younger patients should be considered only when explicit indications outweigh the associated risks of the surgery and modified demands regarding activity and joint loading are assured. This includes all patients who may or may not have multiple joint involvement, for whom restoration of joint mobility leads to an expectation of greater mobility and an improvement in the quality of life.

Mark Mleux

(Division Si
Division of General Restorative
and Neurological Devices

510(k) Number
K030151