CONSENSUS UNIPOLAR HEAD, COCR

K030205 · Hayes Medical, Inc. · KWL · Apr 1, 2003 · Orthopedic

Device Facts

• Record ID: K030205
• Device Name: CONSENSUS UNIPOLAR HEAD, COCR
• Applicant: Hayes Medical, Inc.
• Product Code: KWL · Orthopedic
• Decision Date: Apr 1, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3360
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The cobalt-chrome unipolar 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: A) Primary intervention of rheumatoid arthritis, osteoarthritis, post traumatic arthritis or degenerative arthritis, and avascular necrosis with a non-acute fracture of the femoral neck. B) Osteoarthrosis involving femoral and acetabular articular surfaces. C) Avascular osteonecrosis and/or non-union of acute femoral neck fractures. D) Fracture or dislocation of the hip. E) Replacement of unsatisfactory cemented or press fit hip components if sufficient bone stock exists. With UniSyn® System: A) Significantly impaired joints resulting from rheumatoid, osteo, and post-traumatic arthritis. B) Revision of failed femoral head replacement, hip arthroplasty or other hip procedures. C) Proximal femoral fractures. D) Avascular necrosis of the femoral head. E) Non-union of proximal femoral neck fractures. F) 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. G) 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

Cobalt-chrome unipolar femoral head prosthesis; designed for use exclusively with Consensus or UniSyn Hip Systems. Functions as replacement component for femoral head in hip arthroplasty procedures. Implanted by orthopedic surgeons in clinical/hospital settings. Restores joint mobility; improves patient quality of life by addressing degenerative, traumatic, or metabolic hip conditions. Device provides structural replacement for damaged femoral head; facilitates articulation within acetabulum or existing hip system components.

Clinical Evidence

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

Technological Characteristics

Cobalt-chrome alloy unipolar femoral head. Designed for cemented or uncemented use within specific proprietary hip systems (Consensus/UniSyn). Mechanical implant; no energy source or software.

Indications for Use

Indicated for skeletally mature patients requiring hip arthroplasty due to rheumatoid, osteoarthritis, post-traumatic arthritis, degenerative arthritis, avascular necrosis, femoral neck fractures, hip dislocation, or revision of failed prior hip procedures. Contraindicated in patients without skeletal maturity; use in younger patients requires careful risk-benefit assessment.

Regulatory Classification

Identification

A hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis is a device intended to be implanted to replace a portion of the hip joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum. This generic type of device includes designs which are intended to be fixed to the bone with bone cement (§ 888.3027) as well as designs which have large window-like holes in the stem of the device and which are intended for use without bone cement. However, in these latter designs, fixation of the device is not achieved by means of bone ingrowth.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings and head.

Public Health Service

APR 0 1 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. William J. Griffin QS&RA Manager Hayes Medical, Inc. 1115 Windfield Way, Suite 100 El Dorado Hills, CA 95762-9623

Re: K030205

Trade Name: Consensus Unipolar Head, CoCr Regulation Number: 21 CFR 888.3360 Regulation Name: Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis Regulatory Class: II Product Code: KWL Dated: January 15, 2003 Received: January 21, 2003

Dear Mr. Griffin:

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 - 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 and additionally 21 CFR Part 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" (21CFR Part 807.97). 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 vours.

for Mark N. Millerson

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

Enclosure

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## Section 8 Statement of Indications for Use

The cobalt-chrome unipolar 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:

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

## With UniSyn® System:

- A) Significantly impaired joints resulting from rheumatoid, osteo, and post-traumatic arthritis.
- B) Revision of failed femoral head replacement, hip arthroplasty or other hip procedures.
- C) Proximal femoral fractures.
- D) Avascular necrosis of the femoral head.
- E) Non-union of proximal femoral neck fractures.
- F) 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.
- G) 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 A. Milleson
(Division Sign-Off) MNR

Division of General, Restorative and Neurological Devices

K030205
(V.A.R.) Number