FDA 510(k)

Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing Insert

Número K: K253637 · 2026-02-18

RequerenteHowmedica Osteonics Corp., Dba Stryker Orthopaedics

Data da decisão2026-02-18

Código do produtoMBH

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing Insert is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica Osteonics Corp., Dba Stryker Orthopaedics. It received FDA 510(k) clearance on 2026-02-18 under 510(k) number K253637. The device is classified under product code MBH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing Insert?

Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing Insert is a medical device that received FDA 510(k) clearance on 2026-02-18. The listed applicant is Howmedica Osteonics Corp., Dba Stryker Orthopaedics. The 510(k) number is K253637.

When did Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing Insert receive FDA 510(k) clearance?

Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing Insert received FDA 510(k) clearance on 2026-02-18, under 510(k) number K253637.

Who is the listed applicant for Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing Insert?

The FDA 510(k) record lists Howmedica Osteonics Corp., Dba Stryker Orthopaedics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing Insert?

The FDA product code for Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing Insert is MBH.

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Outros registros que listam Howmedica Osteonics Corp., Dba Stryker Orthopaedics como candidato(a)

K261898Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee System K261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained Acetabular Insert; Trident® Crossfire® 0° Polyethylene Insert; Trident ® Crossfire ® 10° Polyethylene Insert;System 12 Crossfire® 10° Insert; Trident® 0° Constrained Acetabular Insert; Trident® Constrained Acetabular Liner;Trident® All Poly Constrained Acetabular Insert; Crossfire® Eccentric Insert 10°; Artisan® Bone Plug;UHR® Universal Head Bipolar Component K252898Triathlon® Tritanium® Asymmetric Patella; Triathlon® Tritanium® Symmetric Patella; Triathlon® Symmetric Patella; Triathlon® Asymmetric Patella; Scorpio® Universal Dome Patella; Triathlon® Hinge Bumper K252044Triathlon® Total Knee System - Triathlon® Gold Femoral Components K251665Triathlon® Hinge Knee System K250989Stryker and Serf hip devices

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Fonte oficial

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