FDA.report

510(k) K230416

Device
Triathlon® Hinge Knee System; Triathlon® Revision Insert X3®
Applicant
Stryker
510(k) number
K230416
Product code
KRO
Decision
Substantially Equivalent (SESE)
Decision date
2023-05-19
Date received
2023-02-16
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

Related Records

Applicant Contact

Contact
Allison Byrne
Address
325 Corporate Dr. Mahwah NJ US 07430 07430

FDA Registration Numbers

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code KRO

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
K233980ATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb Preservation System, Sigma High Performance (HP) Partial Knee SystemDepuy Ireland UC2024-03-21
K230563EVOLUTION® Hinge Knee SystemMicroport Orthopedics, Inc.2023-09-27
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