PLUS BIPOLAR PROSTHESIS COCRMO

K982447 · Plus Orthopedics · KWY · Nov 25, 1998 · Orthopedic

Device Facts

• Record ID: K982447
• Device Name: PLUS BIPOLAR PROSTHESIS COCRMO
• Applicant: Plus Orthopedics
• Product Code: KWY · Orthopedic
• Decision Date: Nov 25, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3390
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Plus Bipolar Prosthesis CoCrMo in intended for use in arthroplasty therapy as a result of femoral neck fractures and is to be used in conjunction with standard femoral replacement implant. This device is intended for Cementless use only.

Device Story

One-piece bipolar hip joint prosthesis; CoCrMo shell, polyethylene insert, polyethylene security ring. Functions as hemi-hip replacement; self-centering positive-excentric design promotes neutral implant position; main articulation occurs between implant femoral head and bipolar prosthesis to protect acetabulum; built-in security ring reduces dislocation risk; polyethylene insert fastened to metal shell to prevent micromotion/wear; highly polished metal surface minimizes friction. Used in orthopedic surgery; implanted by surgeons in clinical settings. Benefits include improved stability, reduced wear, and protection of acetabular cartilage.

Clinical Evidence

No clinical data provided.

Technological Characteristics

Materials: CoCrMo alloy shell, polyethylene insert, polyethylene security ring. Design: One-piece bipolar hip joint prosthesis. Features: Self-centering positive-excentric geometry, integrated security ring, fixed polyethylene insert. Sterilization: Not specified.

Indications for Use

Indicated for patients requiring arthroplasty therapy due to femoral neck fractures. Contraindications: acute/chronic local or systemic infections; serious muscle, nerve, or blood vessel lesions; bony defects or poor bone quality endangering implant stability; concurrent disease interfering with implant function.

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.

Predicate Devices

• Foundation Hip System, Bipolar Assembly, Encore Orthopedics (K953510)

Submission Summary (Full Text)

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## NOV 25 1998

K 982447

Premarket Notification 510(k) PLUS Bipolar Prosthesis CoCrMo July 8, 1998

## 510(k) Summary of Safety and Effectiveness

September 11, 1998

- PLUS Bipolar Prosthesis CoCrMo Trade name:
- Bipolar Hip Joint Prosthesis Common name:

Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented Classification name: prosthesis (87KWY)

Foundation Hip System, Bipolar Assembly, Encore Orthopedics, Equivalence: Austin, Texas (K953510).

- The PLUS Bipolar Prosthesis CoCrMo is a one-piece hip joint Characteristics: prosthesis comprised of a CoCrMo shell, a polyethylene insert and polyethylene security ring. The advantages are 1) self-centering effect of the positive-excentric Bipolar prosthesis promotes the neutral position of the implant, 2) protects the acetabulum because the main articulation is between the implant femoral head and the Bipolar prosthesis. 3) optimum protection against the risk of dislocation with a built-in security ring, 4) the polyethylene insert is firmly fastened into the metal shell which prevents micromotion and polyethylene wear, 5) highly polished metal surface minimizes friction between implant and acetabulum.
- The PLUS Bipolar Prosthesis CoCrMo is intended for use in Indications: arthroplasty therapy as a result of femoral neck fractures and is to be used in conjunction with standard femoral replacement implants.
- Contraindications include acute or chronic infections (local or Contraindications: systemic), serious lesions of muscles, nerves or blood vessels, which put the affected limb at risk, bony defects or poor bone quality, which might endanger the stability of the prosthesis, and any concurrent disease, which might interfere with the function of the implant.
- None provided at this time. Performance data:

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Image /page/1/Picture/10 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 5 1998

Mr. Hartmut Loch Chief Executive Officer Plus Orthopedics 3550 General Atomics Court Building 15-100 San Diego, California 92121-1122

K982447 Re: Plus Bipolar Prosthesis CoCrMo Trade Name: Regulatory Class: II Product Code: KWY Dated: September 11, 1998 September 14, 1998 Received:

Dear Mr. Loch:

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 The general controls provisions of the Act 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 requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਜੋ 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 regulatory In addition, FDA may publish further announcements action. 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 - Mr. Hartmut Loch

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 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 requlation (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.gov/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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Page 1 of 1

510(k) Number (if known): K982447

Device Name: Plus Bipolar Prosthesis CoCrMo

Indications For Use:

The Plus Bipolar Prosthesis CoCrMo in intended for use in arthroplasty therapy as a result of femoral neck fractures and is to be used in conjunction with standard femoral replacement implant. This device is intended for Cementless use only.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

ice Evaluation (SDE)

Prescription Use_y2 (Per 21 CFR 801.1b9)

OR

Over-The-Counter Use K6

(Optional Format 1-2-96)