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510(k) K172326

Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System by Stryker Orthopaedics — Product Code JWH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 30, 2017
Date Received
August 1, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Device Class
Class II
Regulation Number
888.3560
Review Panel
OR
Submission Type

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  • K173849 — Triathlon Total Knee System (February 2, 2018)
  • K153345 — Stryker Orthopaedics Hip Systems Labeling Update (May 25, 2016)
  • K151264 — Restoration Anatomic Shell (August 10, 2015)
  • K143085 — Stryker Orthopaedics Acetabular Shells, Femoral Stems and Total Hip Instruments (February 9, 2015)
  • K143393 — Triathlon Tritanium Cone Augments (January 13, 2015)
  • K142462 — Restoration Anatomic Shell (November 14, 2014)
  • K141056 — TRIATHLON KNEE SYSTEM POSTERIOR STABILIZED COMPONENTS (August 5, 2014)

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