UNICONDYLAR INTERPOSITIONAL SPACER

• K Number: K003269
• Device Name: UNICONDYLAR INTERPOSITIONAL SPACER
• Manufacturer: SULZER ORTHOPEDICS, INC.
• Date Cleared: 2001-01-04 ( 78 days)
• Product Code: HSH
• Regulation Number: 888.3590

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

§ 888.3590 Knee joint tibial (hemi-knee) metallic resurfacing uncemented prosthesis.

(a)
Identification. A knee joint tibial (hemi-knee) metallic resurfacing uncemented 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 prosthesis is made of alloys, such as cobalt-chromium-molybdenum, and is intended to resurface one tibial condyle. The generic type of device is limited to those prostheses intended for use without bone cement (§ 888.3027).(b)
Classification. Class II.

Summary

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