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510(k) K251270

Taperloc® Complete Hip Stem by Biomet, Inc. — Product Code LPH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 19, 2026
Date Received
April 24, 2025
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

Other clearances by Biomet, Inc.

  • K241014 — Biomet Kirschner Wires (K-Wires) (May 22, 2024)
  • K222760 — StageOne™ Select Hip Cement Spacer Molds (December 28, 2022)
  • K221968 — StageOne™ Shoulder Cement Spacer Molds (September 15, 2022)
  • K213287 — StageOne Knee Cement Spacer Molds (September 2, 2022)
  • K212431 — Biomet Answer/Impact/Integral Distal Centralizer/Centering Sleeve (February 7, 2022)
  • K212435 — Comprehensive Humeral Fracture Positioning Sleeves (December 10, 2021)
  • K210192 — A.L.P.S. Clavicle Plating System (February 19, 2021)
  • K193214 — WasherLoc and No-Profile Screw and Washer Systems, Biomet Cannulated Screw Syste (November 10, 2020)
  • K193546 — Distal Centralizers (September 25, 2020)
  • K193373 — Comprehensive® Reverse Shoulder (April 15, 2020)

Other clearances for product code LPH

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  • K251043 — Mpact 3D Metal Implants Extension – DMLS Technology (January 28, 2026)
  • K252067 — Velora Acetabular System (December 5, 2025)
  • K252846 — TaperSet™ Hip System (November 20, 2025)
  • K251833 — EMPOWR Acetabular® Liner Extension (November 12, 2025)
  • K251718 — ArTT Augments and Buttresses and Bone Screws (August 29, 2025)
  • K250989 — Stryker and Serf hip devices (July 25, 2025)
  • K243456 — ONVOY™ Acetabular System (June 6, 2025)
  • K242744 — Trinity EVO Acetabular Shell (June 5, 2025)