Skip to content

ATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb Preservation System, Sigma High Performance (HP) Partial Knee System

by DePuy Ireland UC

510(k) K233980

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) K233980↗

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 NumberK233980 Date21 Mar 2024ClearedStatusActive
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  • Withdrawn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
KRO
Device Class
Class II
Regulation
21 CFR Part 888.3510
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 ATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb Preservation System, and Sigma High Performance Partial Knee System are orthopedic prostheses classified as knee replacements. These devices are designed to restore function and alleviate pain in patients with damaged articular surfaces of the knee, including total knee, cementless total knee, limb preservation, and partial knee replacements. The systems incorporate metal/polymer components to replace the femur-tibia interface, with some models featuring constrained designs for enhanced stability.

These devices are intended for use in orthopedic surgical settings and are supplied as sterile, single-use implants. The ATTUNE and Sigma systems are regulated under FDA 510(k) clearance and EU MDR, with specific FEI numbers listed for traceability. The systems are available in multiple sizes and configurations, as indicated by the provided registration and FEI numbers, and are intended for use by trained orthopedic surgeons in accredited facilities. No MRI safety information is specified in the provided data.

Other devices from DePuy Ireland UC

See all devices from DePuy Ireland UC →