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510(k) K153345

Stryker Orthopaedics Hip Systems Labeling Update by Stryker Orthopaedics — Product Code LPH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 25, 2016
Date Received
November 19, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Device Class
Class II
Regulation Number
888.3358
Review Panel
OR
Submission Type

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  • K173849 — Triathlon Total Knee System (February 2, 2018)
  • K172326 — Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System (October 30, 2017)
  • 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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  • K242744 — Trinity EVO Acetabular Shell (June 5, 2025)
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