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510(k) K172634

Triathlon® X3® UHMWPE Tibial Inserts and Patellar Components by Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics — Product Code MBH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 16, 2017
Date Received
September 1, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Device Class
Class II
Regulation Number
888.3565
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)
  • 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)
  • K180612 — Triathlon PKR X3 Tibial Inserts, Mako X3 Uni Onlay Tibial Inserts (June 7, 2018)
  • 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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