Home / 510(k) Clearances / K254077

510(k) K254077

OSSIOfiber® Threaded Trimmable Fixation Nail by OSSIO , Ltd. — Product Code HWC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 1, 2026
Date Received
December 18, 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 OSSIO , Ltd.

  • K254055 — OSSIOfiber® Suture Anchor (February 24, 2026)
  • K252022 — OSSIOfiber® Interference Screw (August 19, 2025)
  • K251309 — OSSIOfiber® Suture Anchor (May 27, 2025)
  • K243760 — OSSIOfiber® Suture Anchor 2.5-3.5 mm (April 3, 2025)
  • K241932 — OSSIOfiber® Compression Staple (August 28, 2024)
  • K241277 — OSSIOfiber® Threaded Trimmable Fixation Nail (July 3, 2024)
  • K233198 — OSSIOfiber® Threaded Trimmable Fixation Nails (March 8, 2024)
  • K231272 — OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimm (December 1, 2023)
  • K233302 — OSSIOfiber® Compression Staple (November 16, 2023)
  • K230750 — OSSIOfiber® Cannulated Trimmable Fixation Nail (September 13, 2023)

Other clearances for product code HWC

  • K253108 — VEOFIX Snap Off Screw (June 5, 2026)
  • K261154 — CoLink® & CoLag® Non-Sterile Screws (May 30, 2026)
  • K261241 — TriMed Compression Screws (May 14, 2026)
  • K254215 — Arthrex Beaming System (May 8, 2026)
  • 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)
  • K254110 — DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaCl (March 18, 2026)
  • K260361 — Treace Medical Concepts (TMC) Screw Fixation System (March 6, 2026)
  • K252901 — Tyber Medical Trauma Screw (December 31, 2025)