FDA.reportPublic FDA data

510(k) K233980

Device
ATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb Preservation System, Sigma High Performance (HP) Partial Knee System
Applicant
Depuy Ireland UC
510(k) number
K233980
Product code
KRO
Decision
Substantially Equivalent (SESE)
Decision date
2024-03-21
Date received
2023-12-18
Regulation
888.3510
Classification name
Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Meagan Robles
Address
Loughbeg Ringaskiddy IE

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code KRO#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K252898Triathlon® Tritanium® Asymmetric Patella; Triathlon® Tritanium® Symmetric Patella; Triathlon® Symmetric Patella; Triathlon® Asymmetric Patella; Scorpio® Universal Dome Patella; Triathlon® Hinge BumperHowmedica Osteonics Corp., Dba Stryker Orthopaedics2025-12-15
K252303Stem Extension Line (USTAR II System)United Orthopedic Corporation2025-08-22
K251665Triathlon® Hinge Knee SystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics2025-07-25
K242871ATTUNE™ Revision Hinge KneeDepuy Ireland UC2024-11-21
K240043EVOLUTION® 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 InseMicroport Orthopedics, Inc.2024-04-01
K230563EVOLUTION® Hinge Knee SystemMicroport Orthopedics, Inc.2023-09-27
K230416Triathlon® Hinge Knee System; Triathlon® Revision Insert X3®Stryker2023-05-19
K223069Modular Rotating Hinge Knee Systems and Compatible ComponentsHowmedica Osteonics Corp., Dba Stryker Orthopaedics2023-04-21
K223528Triathlon® Hinge Knee SystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics2023-01-20
K220628LINK Endo-Model EVO Knee SystemWaldemar Link GmbH & Co. KG2022-05-03
K211677ELEOS Limb Salvage SystemOnkos Surgical2021-07-28
K211768LINK Endo-Model Knee System, Femoral Segments (Augments), UHMWPEWaldemar Link GmbH & Co. KG2021-06-30
K210010GMK Revision & Hinge Extension - TiNbN CoatingMedacta International S.A.2021-03-02
K192798Zimmer Segmental SystemZimmer, Inc.2020-12-10
K190181Instruments for LINK MEGASYSTEM-C FamilyLinkBio Corp.2019-10-25