Atlas FDA

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

FDA 510(k) clearance K233980 · decided 2024-03-21

Clearance details

K-number
K233980
Device name
ATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb Preservation System, Sigma High Performance (HP) Partial Knee System
Applicant
Depuy Ireland UC
Decision
Substantially Equivalent
Date received
2023-12-18
Decision date
2024-03-21
Days to decision
94 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
ATTUNE™ Revision Hinge Knee (K242871)Depuy Ireland UC2024-11-21
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
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

No recalls on record reference this clearance.