DEPUY AGILITY LP TOTAL ANKLE PROSTHESIS

• K Number: K122395
• Device Name: DEPUY AGILITY LP TOTAL ANKLE PROSTHESIS
• Manufacturer: DEPUY ORTHOPAEDICS, INC.
• Date Cleared: 2012-10-31 ( 85 days)
• Product Code: HSN
• Regulation Number: 888.3110
• Type: Special
• Panel: OR
• Reference & Predicate Devices: N/A

Intended Use

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Device Description

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AI/ML Overview

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Regulation Number and Section

§ 888.3110 Ankle joint metal/polymer semi-constrained cemented prosthesis.

(a)
Identification. An ankle joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace an ankle joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces and has no linkage across-the-joint. This generic type of device includes prostheses that have a talar resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a tibial 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.