Home / 510(k) Clearances / K254110

510(k) K254110

DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip Delta; DynaClip Quattro by MedShape, Inc. — Product Code HWC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 18, 2026
Date Received
December 19, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Screw, Fixation, Bone
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type

Other clearances by MedShape, Inc.

  • K250628 — DynaNail TTC Fusion System (September 12, 2025)
  • K240530 — DynaNail Mini Tapered Hybrid (March 21, 2024)
  • K220812 — DynaClip® Bone Staple (August 19, 2022)
  • K203595 — DynaFuse Fixation System (January 4, 2022)
  • K203381 — Dynanail Mini Hybrid (January 15, 2021)
  • K193305 — DynaClip Bone Staple (April 23, 2020)
  • K182677 — DynaNail Mini (February 14, 2019)
  • K181781 — DynaClipTM Bone Staple (November 5, 2018)
  • K171376 — DynaNail TTC Fusion System (November 2, 2017)
  • K141420 — FASTFORWARD (December 18, 2014)

Other clearances for product code HWC

  • K260934 — TITAN Nail; APTUS K-Wire System (April 17, 2026)
  • K252699 — CoAptix S System (April 10, 2026)
  • K253042 — Tyber Medical Trauma Screw (April 3, 2026)
  • K260361 — Treace Medical Concepts (TMC) Screw Fixation System (March 6, 2026)
  • K252901 — Tyber Medical Trauma Screw (December 31, 2025)
  • K251555 — Ultra™ Compression Screw System (November 6, 2025)
  • K252312 — Eleganz IM Threaded Nail System (IM Threaded Nail System) (October 10, 2025)
  • K250536 — MetaFore Small Screw System (October 8, 2025)
  • K252758 — Cannulated Screw and Kirschner (K wire) System (October 2, 2025)
  • K252019 — CurvaFix Low Profile System (August 29, 2025)