KRO — Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer Class II

FDA Device Classification

Classification Details

Product Code
KRO
Device Class
Class II
Regulation Number
888.3510
Submission Type
Review Panel
OR
Medical Specialty
Orthopedic
Implant
Yes

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K252898howmedica osteonics corp., dba stryker orthopaedicsTriathlon® Tritanium® Asymmetric Patella; Triathlon® Tritanium® Symmetric PatellDecember 15, 2025
K252303united orthopedic corporationStem Extension Line (USTAR II System)August 22, 2025
K251665howmedica osteonics corp., dba stryker orthopaedicsTriathlon® Hinge Knee SystemJuly 25, 2025
K242871depuy ireland ucATTUNE™ Revision Hinge KneeNovember 21, 2024
K240043microport orthopedicsEVOLUTION® Hinge Knee System;GUARDIAN™ limb Salvage System;DCW Modular Distal FeApril 1, 2024
K233980depuy ireland ucATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb Preservation SMarch 21, 2024
K230563microport orthopedicsEVOLUTION® Hinge Knee SystemSeptember 27, 2023
K230416strykerTriathlon® Hinge Knee System; Triathlon® Revision Insert X3®May 19, 2023
K223069howmedica osteonics corp., dba stryker orthopaedicsModular Rotating Hinge Knee Systems and Compatible ComponentsApril 21, 2023
K223528howmedica osteonics corp., dba stryker orthopaedicsTriathlon® Hinge Knee SystemJanuary 20, 2023
K220628waldemar link gmbh and co. kgLINK Endo-Model EVO Knee SystemMay 3, 2022
K211677onkos surgicalELEOS Limb Salvage SystemJuly 28, 2021
K211768waldemar link gmbh and co. kgLINK Endo-Model Knee System, Femoral Segments (Augments), UHMWPEJune 30, 2021
K210010medacta internationalGMK Revision & Hinge Extension - TiNbN CoatingMarch 2, 2021
K192798zimmerZimmer Segmental SystemDecember 10, 2020
K190181linkbioInstruments for LINK MEGASYSTEM-C FamilyOctober 25, 2019
K191779depuy(ireland)Attune Revision LPS InsertsOctober 8, 2019
K190100united orthopedic corporationUSTAR II SystemSeptember 23, 2019
K172347medacta internationalGMK Hinge, GMK RevisionNovember 1, 2017
K163311medacta internationalGMK Revision Femoral Distal AugmentationDecember 21, 2016