150MM COCR BIMETRIC HEAD/NECK REPLACEMENT HIP STEM- COLOR BUFF FINISH

K983710 · Biomet, Inc. · JDI · Dec 2, 1998 · Orthopedic

Device Facts

• Record ID: K983710
• Device Name: 150MM COCR BIMETRIC HEAD/NECK REPLACEMENT HIP STEM- COLOR BUFF FINISH
• Applicant: Biomet, Inc.
• Product Code: JDI · Orthopedic
• Decision Date: Dec 2, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3350
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Biomet's Bi-Metric CoCr Head/Neck Color Buff Replacement Hip Stem is intended to be implanted to replace a damaged hip joint having large defects in the calcar region as a result of trauma or degenerative disease and in cases where a previous hip replacement component has failed. This device is a single use implant intended for cemented application.

Device Story

Metallic femoral hip stem designed for cemented implantation; replaces proximal femur in cases of severe bone loss or failed previous replacement. Features medial build-up for bone deficiency compensation; keel for proximal load transfer and torsional resistance; lateral flange suture holes for trochanter reattachment. Proximal platform bead-blasted; distal stem features highly polished 'Color Buff' finish (spec Q00999) to facilitate subsidence within cement mantle and reduce loosening. Tapered geometry parallels femoral canal to distribute stress. Modular head taper-fit at surgery. Used in orthopedic surgery to restore hip joint function; provides stable articulation with acetabular component. Benefits patient by addressing severe bone loss and restoring joint stability.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on design, material, and functional comparison to predicate devices.

Technological Characteristics

Material: Wrought cobalt-chrome-molybdenum (ASTM F-1537). Design: Modular femoral stem with 4-degree trunion taper. Surface: Bead-blasted proximal platform; polished 'Color Buff' distal finish. Fixation: Cemented (PMMA distal positioner). Connectivity: None. Sterilization: Not specified.

Indications for Use

Indicated for noninflammatory degenerative joint disease (osteoarthritis, avascular necrosis), rheumatoid arthritis, correction of functional deformity, and treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement unmanageable by other techniques. Single use, cemented application only.

Regulatory Classification

Identification

A hip joint metal/polymer semi-constrained cemented 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 includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).

Predicate Devices

• HNR (Howmedica)
• Solution (DePuy)
• Modular Calcar (Zimmer)
• Bi-Metric CoCr Head Neck Replacement - Grit Blast Finish (Biomet)

Reference Devices

• Zirconia Ceramic Heads (K905687)

Submission Summary (Full Text)

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## SUMMARY OF SAFETY AND EFFECTIVENESS

| Sponsor: | Biomet, Inc.<br>Airport Industrial Park<br>Warsaw, Indiana 46580 |
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Device: Bi-Metric CoCr Head/Neck Color Buff Replacement Hip Stem

Classification Name: Hip joint metal/polymer/metal semi-constrained cemented prosthesis

Intended Use: Biomet's Bi-Metric CoCr Head/Neck Color Buff Replacement Hip Stem is intended to be implanted to replace a damaged hip joint having large defects in the calcar region as a result of trauma or degenerative disease and in cases where a previous hip replacement component has failed.

This device is a single use implant intended for cemented application.

Device Description: The device is composed of a metallic femoral stem which is designed to articulate with a commercially available acetabular component. The device limits translation and rotation via the geometry of the articulating surface. There is no linkage across the joint.

Proximally, the stem is designed to replace the proximal portion of the femur in cases of severe bone loss. The medial portion is built up to compensate for bone deficiencies. It is further enhanced by a keel, which allows transfer of the proximal load to the calcar region, and resists torsional forces.

There are suture holes in the lateral flange of the proximal platform for reattaching and securing the greater trochanter in cases where a trochanter osteotomy has been performed.

The platform inside the collar is bead blasted; the stem outside the collar distally has a highly polished surface with a mirror-like appearance (according to Biomet's Color Buff Finish spec Q00999). This surface finish allows for some subsidence of the stem within the cement mantle and decrease the incidence of stem loosening.

A proximal to distal taper of the femoral stem parallels the shape of the femur to follow the natural contours of the canal. The tapered geometry loads the cement mantle in compression and promotes evenly distributed stress off-loading. The employment of a PMMA distal stem positioner centralizes the stem within the canal.

The femoral component utilizes a modular head which is taper-fit onto the stem at the time of surgery. The modular heads are manufactured from wrought cobalt-chromemolybdenum conforming to ASTM F-1537. The stem trunions are identical to Biomet's Type I Tapers for the Zirconia Ceramic Heads cleared in 510(k) K905687. There is a 4 degree included angle on the trunion.

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Potential Risks: The potential risks associated with this device are the same as with any joint replacement device. These include, but are not limited to:

Reaction to bone cement Fracture of the components Cardiovascular disorders Implant loosening/migration Soft tissue imbalance Deformity of the joint Delayed wound healing Fracture of the cement Tissue growth failure

Bone fracture Hematoma Blood vessel damage Nerve damage Excessive wear Infection Metal sensitivity Dislocation

Substantial Equivalence: In function and overall design Biomet's Bi-Metric CoCr Head/Neck Color Buff Replacement Hip Stem Prosthesis is equivalent to other commercially available hip prosthesis currently on the market. These devices include:

> HNR (Howmedica) Solution (DePuy) Modular Calcar (Zimmer) Bi-Metric CoCr Head Neck Replacement - Grit Blast Finish (Biomet)

## Component Listing

Item #

Description

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## 2 1998 DEC

Mr. Fred McClure Requlatory Specialist Biomet, Inc. P.O. Box 587 46581-0587 Warsaw, Indiana

K983710 Re: 150mm CoCr BiMetric Head/Neck Replacement Trade Name: Hip Stem - Color Buff Finish Requlatory Class: II Product Codes: JDI and LZO October 19, 1998 Dated: October 21, 1998 Received:

Dear Mr. McClure:

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 regulations affecting your device can be found in the Code of Federal Requlations, 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 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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This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA assoring of substantial equivalence of your device to a legally marketed predicate device results in a classification for your markets premits 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 viero diagnobero at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact ene promotion and [phone]. Also, please note ene orress of cempitied, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general premation 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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510 (k) Number (if known) : _ K 983710

Device Name: 150mm CoCr BiMetric Head/Neck Replacement Hip Stem - Color Buff Finish

Biomet's 150mm CoCr BiMetric Head/Neck Replacement Hip Stem – Color Indications For Use: Buff Finish Prosthesis is indicated for use in noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis; theumatoid arthritis; correction of functional deformity; treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.

This device is a single use implant intended for cemented application only.

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bidele

(Division Sign Off)
Division of General Restorative Devices
510(k) Number. K983710