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FDA 510(k)

Triathlon® X3® UHMWPE Tibial Inserts and Patellar Components

K-Number: K172634 · 2017-11-16

ApplicantHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics
Decision Date2017-11-16
Product CodeMBH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Triathlon® X3® UHMWPE Tibial Inserts and Patellar Components is a medical device manufactured by Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics. It received FDA 510(k) clearance on 2017-11-16 under approval number K172634. The device is classified under product code MBH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Triathlon® X3® UHMWPE Tibial Inserts and Patellar Components?

Triathlon® X3® UHMWPE Tibial Inserts and Patellar Components is a medical device that received FDA 510(k) clearance on 2017-11-16. It is manufactured by Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics. The 510(k) number is K172634.

When was Triathlon® X3® UHMWPE Tibial Inserts and Patellar Components approved by the FDA?

Triathlon® X3® UHMWPE Tibial Inserts and Patellar Components received FDA 510(k) clearance on 2017-11-16, under approval number K172634.

What company makes Triathlon® X3® UHMWPE Tibial Inserts and Patellar Components?

Triathlon® X3® UHMWPE Tibial Inserts and Patellar Components is manufactured by Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics.

What is the FDA product code for Triathlon® X3® UHMWPE Tibial Inserts and Patellar Components?

The FDA product code for Triathlon® X3® UHMWPE Tibial Inserts and Patellar Components is MBH.

Related Clinical Trials

NCT06019832 Analysis of Varus Collapse in Obese Patients With Stem and Non-Stem Tibial Components Following Primary Total Knee Arthroplasty ACTIVE_NOT_RECRUITING NCT04358601 All-poly Versus Metal-backed ACTIVE_NOT_RECRUITING NCT07544264 Evaluation of 5-year Survival and Clinical Outcomes in Patients Undergoing Total Knee Arthroplasty With a Polyethylene Tibial Component NOT_YET_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 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 K203099Triathlon PKR System

View all 9 devices →

Related Devices (Code: MBH)

K162256Klassic Femur, Porous, Klassic Tibial Baseplate, PorousTotal Joint Orthopedics, Inc. K153657Vanguard XP Knee SystemBiomet, Inc. K153776Optetrak One Logic Femoral ComponentsExactech, Inc. K153586Arthrex iBalance TKA SystemArthrex, Inc. K171365Arthrex Knee SystemsArthrex, Inc. K171991EMPOWR Porous Knee SystemEncore Medical L.P.

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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