150MM COCR BIMETRIC HEAD/NECK REPLACEMENT HIP STEM- COLOR BUFF FINISH by BIOMET, INC.

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.

Biomet's 150mm CoCr BiMetric Head/Neck Replacement Hip Stem – Color 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.

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.

AI/ML Overview

The provided text is a 510(k) summary for a medical device (Bi-Metric CoCr Head/Neck Color Buff Replacement Hip Stem), which typically focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific clinical trial acceptance criteria and performance data for a novel device. As such, the document does NOT contain the detailed information necessary to fully answer all aspects of your request.

Here's a breakdown of what can and cannot be answered based on the provided text:

1. Table of acceptance criteria and reported device performance:

Cannot be provided. The document does not describe specific acceptance criteria (e.g., specific thresholds for wear rates, fatigue life, or clinical outcomes) or quantitative performance metrics from a study in the format typically used for medical device approval based on novel data. The 510(k) process relies on demonstrating equivalence to an already approved device.

2. Sample size used for the test set and the data provenance:

Cannot be provided. This document is not a clinical study report. It does not mention any test set, sample sizes for human subjects, or data provenance (country of origin, retrospective/prospective) for a study proving acceptance criteria.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Cannot be provided. This information pertains to a study's methodology for establishing ground truth, which is not present in this 510(k) submission.

4. Adjudication method for the test set:

Cannot be provided. Adjudication methods are relevant to clinical studies, which are not detailed here.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Cannot be provided. An MRMC study is completely irrelevant here. This is a hip implant, not an AI-assisted diagnostic tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Cannot be provided. This question is also irrelevant as the device is a physical hip implant and not an algorithm.

7. The type of ground truth used:

Cannot be fully provided in the context of a "study proving acceptance criteria." For mechanical aspects, the "ground truth" would be engineering specifications and testing (e.g., fatigue testing, wear testing against standards), but specific data or thresholds are not in this summary. For clinical outcomes, the "ground truth" for the 510(k) is the established performance and safety of the predicate devices to which it is deemed substantially equivalent, as there's no new clinical trial data presented to establish independent ground truth for this specific device.

8. The sample size for the training set:

Cannot be provided. There is no "training set" as this is not an AI/machine learning device.

9. How the ground truth for the training set was established:

Cannot be provided. As above, no training set.

What the document DOES tell us about "acceptance criteria" in the context of a 510(k):

In a 510(k) submission, "acceptance criteria" are implicitly met by demonstrating substantial equivalence to a predicate device. This means the new device shares the same intended use, similar technological characteristics, and raises no new questions of safety and effectiveness compared to a legally marketed predicate device.

The document states:

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.
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." (Specifically listing HNR, Solution, Modular Calcar, and Biomet's own Grit Blast Finish model).
Technological Characteristics: The document describes the materials (CoCr, Stainless Steel, UHMWPE), design features (collar, keel, polished surface, tapered geometry, modular head, specific taper angle), and manufacturing processes that are comparable to existing devices.
Potential Risks: The document explicitly states, "The potential risks associated with this device are the same as with any joint replacement device." This implies that the device does not introduce new or unmanageable risks beyond what is already accepted for hip replacements.

Therefore, the "study that proves the device meets the acceptance criteria" in this context is the 510(k) submission itself, which primarily relies on comparison to predicate devices and adherence to established engineering and material standards for such implants, rather than a novel clinical trial with specific performance metrics for this particular device. The FDA's letter (K983710) confirms that based on the submission, the device is considered "substantially equivalent" and therefore meets the regulatory "acceptance criteria" for market entry.

Summary

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SUMMARY OF SAFETY AND EFFECTIVENESS

Sponsor:	Biomet, Inc.Airport Industrial ParkWarsaw, 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.

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.

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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 (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact ene promotion and (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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

Regulation Number and Section

§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.

(a)
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).(b)
Classification. Class II.