PIVOT BIPOLAR FEMORAL HEAD

K050966 · Ortho Development Corp. · KWY · Jul 7, 2005 · Orthopedic

Device Facts

• Record ID: K050966
• Device Name: PIVOT BIPOLAR FEMORAL HEAD
• Applicant: Ortho Development Corp.
• Product Code: KWY · Orthopedic
• Decision Date: Jul 7, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3390
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The device is intended for use in hip arthroplasty in cemented and uncemented primary or revision applications whose indications include: - 1. Notably impaired hip joint due to osteoarthritis, rheumatoid arthritis or post traumatic arthritis. - 2. Proximal femoral neck fractures or dislocation. - 3. Idiopathic avascular necrosis of the femoral head. - 4. Non-union of proximal femoral neck fractures. - 5. Treatment of fractures that are unmanageable using other forms of therapy.

Device Story

Pivot™ Bipolar Head is a prosthetic component for hip arthroplasty. It functions as a femoral head replacement in cemented or uncemented applications. Used by orthopedic surgeons in clinical settings to restore hip joint function in patients with degenerative or traumatic conditions. The device replaces the natural femoral head, articulating within the acetabulum or a prosthetic cup to facilitate joint movement and alleviate pain. It is a mechanical implant; no software or electronic components are involved.

Technological Characteristics

Hip joint femoral (hemi-hip) metal/polymer cemented prosthesis. Mechanical implant design. Materials and specifications not detailed in provided text.

Indications for Use

Indicated for patients requiring hip arthroplasty (primary or revision) due to osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, proximal femoral neck fractures/dislocation, idiopathic avascular necrosis of the femoral head, non-union of proximal femoral neck fractures, or fractures unmanageable by other therapies.

Regulatory Classification

Identification

A hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis is a two-part device intended to be implanted to replace the head and neck of the femur. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a snap-fit acetabular component made of an alloy, such as cobalt-chromium-molybdenum, and ultra-high molecular weight polyethylene. This generic type of device may be fixed to the bone with bone cement (§ 888.3027) or implanted by impaction.

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

JUL 7 - 2005

Mr. William J. Griffin Regulatory and Clinical Affairs Manager Ortho Development Corporation 12187 South Business Park Drive Draper, Utah 84020

Re: K050966

Trade/Device Name: Pivot™ Bipolar Head Regulation Number: 21 CFR 888.3390 Regulation Number: 21 CFK 888.5370
Regulation Name: Hip joint femoral (hemi-hip) metal/polymer cemented prosthesis Regulatory Class: II Product Code: KWY Dated: April 14, 2005 Received: April 18, 2005

Dear Mr. Griffin:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section > I of promatics is substantially equivalent (for the indications
referenced above and have determined the cevice is substantially interstate referenced above and have determined the devices marketed in interstate for use stated in the enclosure) to regally manced te of the Medical Device Amendments, or to
commerce prior to May 28, 1976, the enactment of the Federal Food. Drug. commerce prior to May 28, 1970, the claculties and of the Federal Food. Drug, devices that have been reclassified in accordance was are approval application (PMA).
and Cosmetic Act (Act) that do not require approval assesses approvisions of the Act . T and Cosmetic Act (Act) that do not require approvate or a provisions of the Act. The Act. The Act. The Act. The Act. The Act. The Act. The Act. The You may, therefore, market the device, suglest to tire generate for annual registration, listing of
general controls provisions of the Act include requirements for and general controls provisions of the Act mender requirements of the management misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see above) nino chiritir and ri-pentations affecting your device can
may be subject to such additional controls. Existing major regulations all may be subject to such additions. Existing major of Sales 898. In addion, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. be found in the Code of I cuctar regulations, our device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA's issuance of a substitutes with ather requirements of the Act
that FDA has made a determination that your device addes East . You must that FDA has made a delermilation administered by other Federal agencies. You must
or any Federal statutes and regulations administered by other tour spicitation and listing or any Federal statutes and regulations administered or registration and listing (21)
comply with all the Act's requirements, including, but not in registration and listing ( comply with all the Act s requirements, menading martice requirements as set
CFR Part 807); labeling (21 CFR Part 801); end 810); end fastedicable, the electronic CFR Part 807); labeling (21 CFR 1 at 601); good manata 820); add if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Path 21 CFP 1000-1050 forth in the quality systems (QS) regulation (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000

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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) This letter will allow you to begin makemily your aptince of your device of your device to a legally premarket notitication. The FDA inding of substantial oqur 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
rst led If you desire specific advice for your device of the Also, please note the regulation entitled, the may obtain contact the Office of Complance at (210) 217 Cerry Part 807.97). You may obtain
"Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain "Misbranding by reference to premarket nonlineauson (the Act from the Division of Small
other general information on your responsibilities under the Act from worker (800) 638 other general information on your responsion.com its toll-free number [phone] or
Manufacturers, International and Consumer Assistance at its toll-free with he Manufacturers, International and Consumer Abolsance of the Collectivindustry/support/index.html.

Sincerely yours,

Sincerely, J.M.,

Stupt Qurdn

Miriam C. 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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Indications for Use of Device Form

510(k) Number (if known):

Device Name: Pivot™ Bipolar Head

Indications for Use

The device is intended for use in hip arthroplasty in cemented and uncemented primary or revision applications whose indications include:

- 1. Notably impaired hip joint due to osteoarthritis, rheumatoid arthritis or post traumatic arthritis.
- 2. Proximal femoral neck fractures or dislocation.
- 3. Idiopathic avascular necrosis of the femoral head.
- 4. Non-union of proximal femoral neck fractures.
- 5. Treatment of fractures that are unmanageable using other forms of therapy.

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

Over-The-Counter Use (Part 21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Sty Murdu

Division of General, Restorative, and Neurological Devices

Number K050966