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FDA 510(k)

Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System

K-Number: K172326 · 2017-10-30

ApplicantStryker Orthopaedics
Decision Date2017-10-30
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Orthopaedics. It received FDA 510(k) clearance on 2017-10-30 under 510(k) number K172326. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System?

Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System is a medical device that received FDA 510(k) clearance on 2017-10-30. The listed applicant is Stryker Orthopaedics. The 510(k) number is K172326.

When did Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System receive FDA 510(k) clearance?

Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System received FDA 510(k) clearance on 2017-10-30, under 510(k) number K172326.

Who is the listed applicant for Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System?

The FDA 510(k) record lists 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 PKR System, Restoris MCK Knee System?

The FDA product code for Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System is JWH.

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_RECRUITINGNCT02999009Trident II Tritanium Acetabular Shell Outcomes StudyACTIVE_NOT_RECRUITINGNCT05144191Insignia™ Hip Stem Outcomes StudyACTIVE_NOT_RECRUITINGNCT05591859Restoration Anatomic Acetabular Shell Revision StudyWITHDRAWNNCT07647354Mako-MORE RegistryRECRUITING

Other records listing 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.

K211703Insignia Hip StemK191414EXETER Centralizer, EXETER 2.5mm PlugK173499Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral HeadsK173849Triathlon Total Knee SystemK153345Stryker Orthopaedics Hip Systems Labeling Update

Related Devices (Code: JWH)

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.

K261563Freedom Total Knee System (E-Poly Tibial Liners)Maxx Orthopedics, Inc.K262251ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACTIFY MC Tibial Insert)Globus Medical, Inc.K261734Klassic Infection Spacer SystemTotal Joint Orthopedics, Inc.K261458ATTUNE Total Knee System; ATTUNE Cementless Knee SystemDePuy Ireland UCK261032NovoKnee (SteriKnee)NovoSourceK253793Materialise TKA Guide SystemMaterialise NV

Official Source

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

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