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510(k) K203099

Triathlon PKR System by Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics — Product Code HSX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 27, 2020
Date Received
October 14, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
Device Class
Class II
Regulation Number
888.3520
Review Panel
OR
Submission Type

Other clearances by Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics

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  • K210893 — Restoration Anatomic Shell (April 22, 2021)
  • K191358 — Trident II Acetabular System (October 24, 2019)
  • K182468 — Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II Hi (March 19, 2019)
  • K180612 — Triathlon PKR X3 Tibial Inserts, Mako X3 Uni Onlay Tibial Inserts (June 7, 2018)
  • K172634 — Triathlon® X3® UHMWPE Tibial Inserts and Patellar Components (November 16, 2017)
  • K171768 — Trident® II Acetabular System (October 2, 2017)
  • K161569 — Trident® II Tritanium® Acetabular Shells and 6.5 mm Low Profile Hex Screws (October 14, 2016)

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