BI-METRIC CCOCR HEAD/NECK REPLACEMENT SYSTEM

K992058 · Biomet, Inc. · JDI · Jul 1, 1999 · Orthopedic

Device Facts

• Record ID: K992058
• Device Name: BI-METRIC CCOCR HEAD/NECK REPLACEMENT SYSTEM
• Applicant: Biomet, Inc.
• Product Code: JDI · Orthopedic
• Decision Date: Jul 1, 1999
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3350
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Bi-Metric CoCr Head/Neck Replacement Hip Stem is intended for use in cases with a diagnoses of: a) Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis b) Rheumatoid arthritis c) Correction of functional deformities d) Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques e) Revisions of hip replacement components The Bi-Metric CoCr Head/Neck Replacement Hip Stem is intended for cemented application and is a single use device.

Device Story

Cobalt-chromium-molybdenum (Co-Cr-Mo) femoral hip stem; designed for cemented application; articulates with commercially available acetabular components. Features medial build-up for bone deficiency compensation; keel for load transfer to calcar region; lateral flange with suture holes for greater trochanter attachment. Stem surface grit-blasted; collar underside bead-blasted for improved stem/cement fixation. Available in three resection levels (34mm, 45mm, 55mm) and four diameters (9mm, 11mm, 13mm, 15mm); straight or bowed configurations. Used by orthopedic surgeons in clinical settings for hip arthroplasty. Single-use device.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Material: Cobalt-chromium-molybdenum (Co-Cr-Mo) alloy. Design: Femoral stem with medial build-up, keel, and suture holes. Surface treatment: Grit-blasted stem, bead-blasted collar. Dimensions: 34-55mm resection levels; 9-15mm diameters; straight or bowed. Application: Cemented. Single-use.

Indications for Use

Indicated for patients with non-inflammatory degenerative joint disease (osteoarthritis, avascular necrosis), rheumatoid arthritis, functional deformities, or proximal femur fractures (non-union, femoral neck, trochanteric) requiring hip replacement or revision.

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

• Bi-Metric CoCr Head/Neck Replacement Hip Stem (K955350)

Submission Summary (Full Text)

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## K992058

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## SUMMARY OF SAFETY AND EFFECTIVENESS

Biomet , Inc. Submitter: Airport Industrial Park P.O. Box 587 Warsaw, Indiana 4681-0587

Contact Person: Mary L. Verstynen

Product Code: 87JDI

Bi-Metric CoCr Head/Neck Replacement Hip Stems Device Name:

INTENDED USE: The Bi-Metric CoCr Head/Neck Replacement Hip Stem is
In the Bi-Metric Cock and consess of intended for use in cases with a diagnoses of:

- ded for use in cases with a diagnoses on.
a) Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis
- b) Rheumatoid arthritis
- c) Correction of functional deformities
- c) Correction of nunchonial delofinities
d) Treatment of non-union, femoral neck fracture, and trochanteric fractures of I reatment of non-unfon, remoral nock trav, inmanageable using other techniques
- e) Revisions of hip replacement components

The Bi-Metric CoCr Head/Neck Replacement Hip Stem is intended for cemented application and is a single use device.

DEVICE DESCRIPTION: The Bi-Metric CoCr Head/Neck Replacement Hip Stem
Comment of the first and ish in and ish is designed to articulate with a DEVICE DESCRIPTION. The Di-Moral stem which is designed to articulate with a
is a cobalt alloy (Co-Cr-Mo) femoral stem who it has no linkage across the ioint is a cobait anoy (Co-CI-MO) Temoral stom was It has no linkage across the joint.
commercially available acetabular component. It has no linkage across the femur in commercially available acclabular component "It is as semperate for bone of severe bone loss. The medial portion is built up to compensate for bone of severe bone foss. The medial portion is at , which allows transfer of the proximal
deficiencies. It is further enhanced by a keel, which There ene suture holes in the deficiencies. It is further cimanced by a novel forces. There are suture holes in the load to the calcal region, and resists tornemartaching and securing the greater iateral flange of the proximal platform for readed. The platformed. The platform trochanter in cases where a trochants oscoconty the scollar distally is "grit blasted"
inside the collar is "bead blasted"; the stem outside the consimproved fixation mside the conal IS "bead blasted", the clear or viding for an improved fixation between the stem/cement interface.

There are three resection levels: 34mm, 45mm, and 55mm with four diameters: 9mm, I here are three resection levels: 3-milli, 150mm, 200mm, 200mm, and 250mm
11mm, 13, and 15mm. The stems are available in 150mm, steres are boxec I Irmin, 15, and 1511m. The stems are straight and the 250mm stems are bowed right and left specific.

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POTENTIAL RISKS: The potential risks associated with this device are the same as with any joint replacement. These include, but are limited to:

Fracture of the component Deformity of the joint Bone fracture Hematoma Implant loosening/migration Delayed wound healing Blood vessel damage Infection Breakdown of porous surface Soft tissue imbalance Metal sensitivity Nerve damage Cardiovascular disorders Tissue growth failure Excessive wear Dislocation

SUBSTANIAL EQUIVALENCE: The Bi-Metric CoCr Head/Neck Replacement Hip Stem is substantially equivalent to the following predicate device in terms of indications, intended use, design, and material.

Predicate device: Bi-Metric CoCr Head/Neck Replacement Hip Stem, K955350

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the department's name around the perimeter. In the center of the seal is a stylized image of three wavy lines, which are meant to represent the flow of people.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL - 1 1999

Ms. Mary L. Verstynen Biomet, Inc. Airport Industrial Park P.O. Box 587 Warsaw, Indiana 46581-0587

K992058 Re:

Trade Name: Bi-Metric CoCr Head/Neck Replacement System Regulatory Class: II Product Code: JDI Dated: June 15, 1999 Received: June 18, 1999

Dear Ms. Verstynen:

We have reviewed your Section 510(k) notification of intent to market the device referenced we nave reviewed your Boonon 3 re(x) reasustantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the stated in the Energismer) to device Amendments, or to devices that have been reclassified in enacinem date of the Medical Dories I Level, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general therefore, manov the Act include requirements for annual registration, listing of devices, Controlis of the rest ree, 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 (Fremarket Approvat), it may be subject to sacklerial resultations, 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 mopononist the GMP regulation may result in regulatory 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 scotions 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. Mary Verstynen

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 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.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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of Page

510(k) NUMBER (IF KNOWN): __ K992058

DEVICE NAME: Bi-Metric CoCr Head/Neck Replacement Hip Stem

INDICATIONS FOR USE:

The Bi-Metric CoCr Head/Neck Replacement IIip Stem is intended for use in cases with a diagnoses of:

- s Non-inflammatory degenerative joint disease, including osteoarthritis and avascular a) necrosis
- Rheumatoid arthritis b)
- Correction of functional deformities c)
- Correction of non-union, femoral neck fracture, and trochanteric fractures of the d) proximal femur with head involvement, unmanageable using other techniques
- Revisions of hip replacement components e)

The Bi-Metric CoCr Head/Neck Replacement Hip Stem is intended for cemented application and is a single use device.

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

(Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use V (Per 21 CFR 801.109) OR

Over- The- Counter-(Optional Format 1-2 વ્વીર

(Optional Format 1-10)

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K99208

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