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C-Stem AMT LE Prosthesis

by DePuy Ireland UC

510(k) K220216

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K220216↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK220216 Date22 Jul 2022ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA Product Code
JDI
Device Class
Class II
Regulation
21 CFR Part 888.3350
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The C-Stem AMT LE Prosthesis is a femoral component designed for total knee arthroplasty, classified under orthopedic implant devices. It features an anatomical modular taper (AMT) design intended to enhance stability and fit within the distal femur, providing a solution for patients requiring lower extremity joint replacement.

This prosthesis is supplied sterile and intended for single-use, adhering to FDA 510(k) clearance under the traditional review pathway. It is categorized under product code JDI and is manufactured by DePuy Ireland UC, with regulatory compliance also meeting MDR requirements. Storage and handling must follow sterile medical device protocols to ensure integrity prior to surgical use.

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Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the C-Stem AMT LE Prosthesis specifically designed for in knee replacement surgery?

    The C-Stem AMT LE Prosthesis is designed as a femoral component for total knee arthroplasty, focusing on the distal femur. Its anatomical modular taper (AMT) design aims to improve stability and fit, making it suitable for patients undergoing lower extremity joint replacement procedures.

  • Is the C-Stem AMT LE Prosthesis intended for reuse or single-use, and how should it be stored?

    The C-Stem AMT LE Prosthesis is intended for single-use only and is supplied sterile. To maintain sterility and integrity before surgery, it must be stored and handled following sterile medical device protocols, as required for all single-use orthopedic implants.

  • Who manufactures this prosthesis, and what regulatory pathways does it follow?

    The C-Stem AMT LE Prosthesis is manufactured by DePuy Ireland UC (based in Cork, Ireland). It has received FDA 510(k) clearance under the traditional review pathway (K220216) and also complies with MDR (Medical Device Regulation) requirements, ensuring it meets both U.S. and EU regulatory standards.

  • What product code category does this device fall under, and how does that affect its classification?

    This prosthesis is classified under product code JDI, which categorizes it as an orthopedic implant device for the lower extremity. This classification aligns with its use in knee arthroplasty and ensures it adheres to the appropriate regulatory and safety standards for such devices.