Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Triathlon Tritanium Central Femoral Cone Augment, Triathlon Femoral Distal Augment

K-Number: K190991 · 2019-08-15

ApplicantHowmedica Osteonics Corp. (Aka Stryker Orthopaedics)
Decision Date2019-08-15
Product CodeMBH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Triathlon Tritanium Central Femoral Cone Augment, Triathlon Femoral Distal Augment is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica Osteonics Corp. (Aka Stryker Orthopaedics). It received FDA 510(k) clearance on 2019-08-15 under 510(k) number K190991. 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 Tritanium Central Femoral Cone Augment, Triathlon Femoral Distal Augment?

Triathlon Tritanium Central Femoral Cone Augment, Triathlon Femoral Distal Augment is a medical device that received FDA 510(k) clearance on 2019-08-15. The listed applicant is Howmedica Osteonics Corp. (Aka Stryker Orthopaedics). The 510(k) number is K190991.

When did Triathlon Tritanium Central Femoral Cone Augment, Triathlon Femoral Distal Augment receive FDA 510(k) clearance?

Triathlon Tritanium Central Femoral Cone Augment, Triathlon Femoral Distal Augment received FDA 510(k) clearance on 2019-08-15, under 510(k) number K190991.

Who is the listed applicant for Triathlon Tritanium Central Femoral Cone Augment, Triathlon Femoral Distal Augment?

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

What is the FDA product code for Triathlon Tritanium Central Femoral Cone Augment, Triathlon Femoral Distal Augment?

The FDA product code for Triathlon Tritanium Central Femoral Cone Augment, Triathlon Femoral Distal Augment is MBH.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT02521103Triathlon Tritanium Cone Augments Outcomes StudyACTIVE_NOT_RECRUITING

Other records listing Howmedica Osteonics Corp. (Aka Stryker Orthopaedics) as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K193233Restoration® Modular Hip System

Related Devices (Code: MBH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251840Zimmer® Persona® Personalized Knee SystemZimmer, Inc.K253189Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs)Zimmer, Inc.K253328GMK 3D Metal Tibial Tray ExtensionMedacta International S.A.K253637Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing InsertHowmedica Osteonics Corp., Dba Stryker OrthopaedicsK253239Active-V Total Knee System; World Total Knee SystemSignature Orthopaedics Pty, Ltd.K253161Balanced Knee System TriMax Porous Femoral ComponentsOrtho Development Corp.

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.

↑