ODC B2 BIPOLAR CUP

K982389 · Ortho Development Corp. · KWY · Oct 7, 1998 · Orthopedic

Device Facts

• Record ID: K982389
• Device Name: ODC B2 BIPOLAR CUP
• Applicant: Ortho Development Corp.
• Product Code: KWY · Orthopedic
• Decision Date: Oct 7, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3390
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ODC™ B2 Bipolar Cup for the Primaloc™ Hip System is intended for single-use cementless implantation during primary or revision arthroplasty surgery. The bipolar cup allows for primary articulation between the acetabulum and femoral stem to restore patient mobility. Indications for use are: - Osteoarthritis, theumatoid arthritis, or other osteoarthrosis of the hip joint; - Certain femoral neck fractures or dislocations; - Post-traumatic arthritis; - Idiopathic avascular necrosis of the femoral head; - Benign or malignant bone tumors where sufficient bone stock exists to seat the prosthesis: - Previously failed surgery

Device Story

ODC™ B2 Bipolar Cup is a prosthetic component for the Primaloc™ Hip System; designed for cementless implantation during primary or revision hip arthroplasty. Device functions as an articulating interface between the acetabulum and femoral stem to restore patient mobility. Used in surgical settings by orthopedic surgeons. Benefits include restoration of hip joint function and mobility in patients with degenerative or traumatic hip conditions. Device is a mechanical implant; no electronic or software components.

Clinical Evidence

No clinical data provided; substantial equivalence based on design and intended use.

Technological Characteristics

Cementless bipolar hip cup prosthesis; designed for use with the Primaloc™ Hip System. Mechanical implant; no electronic, software, or energy-based components.

Indications for Use

Indicated for patients requiring primary or revision hip arthroplasty due to osteoarthritis, rheumatoid arthritis, other osteoarthrosis, femoral neck fractures/dislocations, post-traumatic arthritis, idiopathic avascular necrosis of the femoral head, benign/malignant bone tumors with sufficient bone stock, or failed previous surgery.

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.

Reference Devices

• Primaloc™ Cementless Hip System (K953977)

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 7 1998

Ms. Carol Freasier Manager, Requlatory Affairs/QA Ortho Development Corporation 106 West Business Park Drive Draper, Utah 84020

K982389 Re: ODC™ B2 Bipolar Cup Trade Name: Regulatory Class: II Product Code: KWY Dated: July 7, 1998 Received: July 9, 1998

Dear Ms. Freasier:

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, Drug, and Cosmetic Act (Act). 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 (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 Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements 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.

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## Page 2 - Ms. Carol Freasier

This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA finding of substantial equivalence of your device to a leqally 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 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.qov/cdrh/dsmamain.html".

Sincerely yours,

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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510(k) Number (if known): K982389

## Device Name: ODC™ B2 Bipolar Cup

## Indications for Use

The ODC™ B2 Bipolar Cup for the Primaloc™ Hip System is intended for single-use cementless implantation during primary or revision arthroplasty surgery. The bipolar cup allows for primary articulation between the acetabulum and femoral stem to restore patient mobility. Indications for use are:

- . Osteoarthritis, theumatoid arthritis, or other osteoarthrosis of the hip joint;
- Certain femoral neck fractures or dislocations; .
- Post-traumatic arthritis; .
- Idiopathic avascular necrosis of the femoral head; ●
- Benign or malignant bone tumors where sufficient bone stock exists to seat the . prosthesis:
- Previously failed surgery ●

The ODC™ B2 Bipolar Cup may be used with the Primaloc™ Cementless Hip System, which is cleared for use under Premarket Notification K953977.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Division Sign-Off)
Division of General Restorative Devices
510(k) Number. K982389

OR

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use (Optional Format 1-2-96)