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510(k) K180612

Triathlon PKR X3 Tibial Inserts, Mako X3 Uni Onlay Tibial Inserts by Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics — Product Code HSX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 7, 2018
Date Received
March 8, 2018
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

  • K233261 — Global Modular Replacement System (December 8, 2023)
  • K210893 — Restoration Anatomic Shell (April 22, 2021)
  • K203099 — Triathlon PKR System (October 27, 2020)
  • 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)
  • 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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