CONSENSUS ACETABULAR INSERT, CROSS-LINKED POLYETHYLENE by HAYES MEDICAL, INC.

The cross-linked polyethylene acetabular insert is design for use with the Consensus or UniSvn ® 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 Description

Cross Linked Polyethylene Acetabular Insert

AI/ML Overview

I am sorry, but there is no information about acceptance criteria or a study proving that the device meets acceptance criteria in the provided text. The document is a 510(k) clearance letter from the FDA, which states that the device is substantially equivalent to previously marketed devices and lists its indications for use. It does not contain performance data or details of a study with acceptance criteria.

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is an abstract symbol that resembles a stylized caduceus or a series of human profiles. The symbol is black, and the background is white.

JUL 2 4 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K021466

Trade Name: Cross Linked Polyethylene Acetabular Insert Regulation Number: 21 CRF 888.3358 Regulation Name: Hip joint metal/polymer metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: Class II Product Code: LPH Dated: May 3, 2002 Received: May 7, 2002

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 (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely vours.

sincerely yours,

Mark N. Millman

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) Cross Linked Polyethylene Acetabular Insert

Section 8 Statement of Indications for Use

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.

for Merle N. Milliken

Division of General. Restorative and Neurological Devices

510(k) Number K021466

Regulation Number and Section

§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.

(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across the joint. This generic type of device has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.