Atlas FDA

ATTUNE™ Revision Hinge Knee

FDA 510(k) clearance K242871 · decided 2024-11-21

Clearance details

K-number
K242871
Device name
ATTUNE™ Revision Hinge Knee
Applicant
Depuy Ireland UC
Decision
Substantially Equivalent
Date received
2024-09-23
Decision date
2024-11-21
Days to decision
59 days
Clearance type
Traditional
Product code
KRO
Device class
2
Regulation number
888.3510
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Ringaskiddy, IE
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee System (K261898)Howmedica Osteonics Corp. dba Stryker Orthopaedics2026-08-06
Triathlon® Tritanium® Asymmetric Patella; Triathlon® Tritanium® Symmetric Patella; Triathlon® Symmetric Patella; Triathlon® Asymmetric Patella; Scorpio® Universal Dome Patella; Triathlon® Hinge Bumper (K252898)Howmedica Osteonics Corp., Dba Stryker Orthopaedics2025-12-15
Stem Extension Line (USTAR II System) (K252303)United Orthopedic Corporation2025-08-22
Triathlon® Hinge Knee System (K251665)Howmedica Osteonics Corp., Dba Stryker Orthopaedics2025-07-25
EVOLUTION® Hinge Knee System;GUARDIAN™ limb Salvage System;DCW Modular Distal Femoral System;REPIPHYSIS™ Limb Salvage System;EVOLUTION® MP Total Knee System; EVOLUTION® MP Total Knee System; EVOLUTION® MP Adaptive CS Insert; EVOLUTION® MP Adaptive PS Tibial Insert; EVOLUTION® MP CS/CR Porous Femur/EVOLUTION® Adaptive CS and PS Inserts; EVOLUTION® Revision CCK System; ADVANCE® Double High Insert; ADVANCE® A-CLASS® Tibial Insert; ADVANCE® Knee System; ADVANCE® Ultra-Congruent Tibial Inse (K240043)Microport Orthopedics, Inc.2024-04-01
ATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb Preservation System, Sigma High Performance (HP) Partial Knee System (K233980)Depuy Ireland UC2024-03-21
EVOLUTION® Hinge Knee System (K230563)Microport Orthopedics, Inc.2023-09-27
Triathlon® Hinge Knee System; Triathlon® Revision Insert X3® (K230416)Stryker2023-05-19
Modular Rotating Hinge Knee Systems and Compatible Components (K223069)Howmedica Osteonics Corp., Dba Stryker Orthopaedics2023-04-21
Triathlon® Hinge Knee System (K223528)Howmedica Osteonics Corp., Dba Stryker Orthopaedics2023-01-20
LINK Endo-Model EVO Knee System (K220628)Waldemar Link GmbH & Co. KG2022-05-03
ELEOS Limb Salvage System (K211677)Onkos Surgical2021-07-28

Recalls involving this device

RecordFirmDate
Depuy Synthes, ATTUNE Revision Hinge Knee Hinge Housing Components with the below product recall (Z-2616-2026)DEPUY (IRELAND)2026-06-29
Depuy Synthes, ATTUNE Revision Hinge Knee Hinge Insert Components with the below product d recall (Z-2617-2026)DEPUY (IRELAND)2026-06-29
Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 4 CEM. Part Number: 150450104. recall (Z-1985-2026)DEPUY (IRELAND)2026-04-29
Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 5 CEM. Part Number: 150450105. recall (Z-1986-2026)DEPUY (IRELAND)2026-04-29
Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 7 CEM. Part Number: 150450107. recall (Z-1987-2026)DEPUY (IRELAND)2026-04-29
Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 8 CEM. Part Number: 150450108. recall (Z-1988-2026)DEPUY (IRELAND)2026-04-29
Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 3 CEM. Part Number: 150450203. recall (Z-1989-2026)DEPUY (IRELAND)2026-04-29
Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 4 CEM. Part Number: 150450204. recall (Z-1990-2026)DEPUY (IRELAND)2026-04-29
Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 5 CEM. Part Number: 150450205. recall (Z-1991-2026)DEPUY (IRELAND)2026-04-29
Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 7 CEM. Part Number: 150450207. recall (Z-1992-2026)DEPUY (IRELAND)2026-04-29
Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 8 CEM. Part Number: 150450208. recall (Z-1993-2026)DEPUY (IRELAND)2026-04-29