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SIGMA High Performance Partial Knee System

by DePuy Ireland UC

510(k) K193549

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) K193549↗

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 NumberK193549 Date16 Apr 2020ClearedStatusActive
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  • Withdrawn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)

Full name
SIGMA High Performance (HP) Partial Knee System
510(k) Number
FDA Product Code
HRY
Device Class
Class II
Regulation
21 CFR Part 888.3530
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 SIGMA High Performance Partial Knee System is a Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer (per FDA nomenclature). It is designed as a fixed-bearing unicompartmental knee implant to replace damaged articular surfaces in patients with degenerative joint disease affecting a single knee compartment, where sufficient bone integrity supports component placement.

This system is intended for use in orthopedic surgical settings and is supplied as a sterile, single-use device. Components are cemented in place and are compatible with MRI environments under specified conditions. The system includes multiple implant sizes and configurations, as referenced by the listed FEI numbers. Authorized under FDA 510(k) clearance and MDR, it adheres to regulatory standards for orthopedic knee prostheses.

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