MODIFICATION TO MILLER/GALANTE PRECOAT UNICOMPARTMENTAL KNEE SYSTEM (8 MM ARTICULAR SURFACE)

• K Number: K010685
• Device Name: MODIFICATION TO MILLER/GALANTE PRECOAT UNICOMPARTMENTAL KNEE SYSTEM (8 MM ARTICULAR SURFACE)
• Manufacturer: ZIMMER, INC.
• Date Cleared: 2001-04-02 ( 25 days)
• Product Code: HSX
• Regulation Number: 888.3520

Intended Use

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Device Description

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Predicate Devices

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Reference Devices

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AI/ML (Artificial Intelligence / Machine Learning)

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Therapeutic

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Diagnostic

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SaMD (Software as a Medical Device)

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IVD (In Vitro Diagnostic)

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PCCP (Predetermined Change Control Plan) Authorized

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Overview

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Regulation Number and Section

§ 888.3520 Knee joint femorotibial metal/polymer non-constrained cemented prosthesis.

(a)
Identification. A knee joint femorotibial metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral condylar resurfacing component or components made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components made of ultra-high molecular weight polyethylene and are intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.

Summary

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