Home / 510(k) Clearances / K250112

510(k) K250112

FitboneTM Trochanteric by Orthofix Srl — Product Code HSB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 10, 2025
Date Received
January 16, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Rod, Fixation, Intramedullary And Accessories
Device Class
Class II
Regulation Number
888.3020
Review Panel
OR
Submission Type

Other clearances by Orthofix Srl

  • K242270 — OrthoNext Platform System (December 19, 2024)
  • K242861 — TrueLok Elevate (December 3, 2024)
  • K233867 — Fitbone Trochanteric (June 18, 2024)
  • K240749 — PILLAR SA Ti Spacer System (82-XXX) (May 28, 2024)
  • K232648 — RODEO Telescopic Nail (May 3, 2024)
  • K232169 — FITBONE® Transport and Lengthening System (March 22, 2024)
  • K213572 — JuniOrtho Plating System™ (January 18, 2022)
  • K212044 — TrueLok Evo (November 5, 2021)
  • K211704 — CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System, CONSTRUX Mini PT (August 31, 2021)
  • K211710 — Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebir (July 30, 2021)

Other clearances for product code HSB

  • K253566 — Affixus Retrograde Femoral Nailing System (March 12, 2026)
  • K253517 — Reselute Tibial Nail (March 10, 2026)
  • K252196 — Arthrex FibuLock Nail System (March 5, 2026)
  • K253591 — Phantom® Hindfoot TTC/TC Nail System (March 5, 2026)
  • K252025 — Active Intramedullary (AIM) Tibial Nail System (March 4, 2026)
  • K253640 — T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction System (February 3, 2026)
  • K253749 — Affixus® Natural Nail® Proximal Humeral System (December 12, 2025)
  • K252826 — ARIX Femur Nail System (December 10, 2025)
  • K250197 — Estremo Fibular Nail (October 17, 2025)
  • K250628 — DynaNail TTC Fusion System (September 12, 2025)