FDA.reportPublic FDA data

510(k) K203099

Device
Triathlon PKR System
Applicant
Howmedica Osteonics Corp Aka Stryker Orthopaedics
510(k) number
K203099
Product code
HSX  
Decision
Substantially Equivalent (SESE)
Decision date
2020-10-27
Date received
2020-10-14
Regulation
888.3520
Classification name
Prosthesis, Knee, Femorotibial, Non-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
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 HSX  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K260796Tahoe Unicondylar Knee System with TiNbN OvercoatShalby Advanced Technologies, Inc. Dba Consensus Orthopedics2026-04-02
K251771Cambridge Partial KneeSignature Orthopaedics Pty, Ltd.2025-12-16
K251834Persona Partial KneeZimmer Biomet2025-08-15
K251618MOTO Partial Knee System ExtensionMedacta International S.A.2025-07-24
K251453Arthrex iBalance Partial Knee SystemArthrex, Inc.2025-07-01
K241260ACTIFY™ Unicondylar Knee SystemGlobus Medical, Inc.2024-12-06
K242711JOURNEY II Unicompartmental Knee System (JOURNEY II UK)Smith & Nephew, Inc.2024-10-30
K242746OvertureTi Knee Resurfacing SystemTMOverture Orthopaedics2024-10-07
K232114TRIBRID® Unicompartmental Knee SystemKyocera Medical Technologies, Inc.2024-04-04
K221292Uni Knee Resurfacing SystemOverture Resurfacing, Inc.2023-03-10
K212870TLC Unicompartmental Knee SystemSignature Orthopaedics Pty, Ltd.2022-06-16
K220930Restoris Multi-Compartmental Knee SystemMako Surgical Corp.2022-06-02
K211471Balanced Knee System UniOrtho Development Corporation2021-12-16
K213071MOTOTM Partial Knee & MOTO PFJ Systems ExtensionMedacta International S.A.2021-11-16
K212307BC Reflex Uni Knee SystemBodycad Laboratories, Inc.2021-10-12

Legacy Summary#

summary

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases