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FDA 510(k)

Triathlon PKR System

K-Number: K203099 · 2020-10-27

ApplicantHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics
Decision Date2020-10-27
Product CodeHSX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Triathlon PKR System is a medical device manufactured by Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics. It received FDA 510(k) clearance on 2020-10-27 under approval number K203099. The device is classified under product code HSX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Triathlon PKR System?

Triathlon PKR System is a medical device that received FDA 510(k) clearance on 2020-10-27. It is manufactured by Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics. The 510(k) number is K203099.

When was Triathlon PKR System approved by the FDA?

Triathlon PKR System received FDA 510(k) clearance on 2020-10-27, under approval number K203099.

What company makes Triathlon PKR System?

Triathlon PKR System is manufactured by Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics.

What is the FDA product code for Triathlon PKR System?

The FDA product code for Triathlon PKR System is HSX.

Related Clinical Trials

NCT04358601 All-poly Versus Metal-backed ACTIVE_NOT_RECRUITING NCT02525601 Evaluation of Triathlon - A New Total Knee Prosthesis System - RSA Triathlon Cruciate Retaining - Cemented vs. Uncemented ACTIVE_NOT_RECRUITING

Other Devices by Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics

K161569Trident® II Tritanium® Acetabular Shells and 6.5 mm Low Profile Hex Screws K172634Triathlon® X3® UHMWPE Tibial Inserts and Patellar Components K171768Trident® II Acetabular System K180612Triathlon PKR X3 Tibial Inserts, Mako X3 Uni Onlay Tibial Inserts K191358Trident II Acetabular System K182468Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II Hip System

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Related Devices (Code: HSX)

K161060Arthrex iBalance UKA System Vitamin E Tibial BearingArthrex, Inc. K161592Persona Partial Knee SystemBiomet, Inc. K160738ZUK Select Knee SystemSmith & Nephew, Inc. K172650Materialise PKA Guide SystemMaterialise NV K170344Tahoe Uni Knee SystemConsensus Orthopedics, Inc. K161741GMK UNIMedacta International S.A.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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