Cleared Traditional

OSSIOfiber? Cannulated Trimmable Fixation Nail

K230750 · OSSIO , Ltd. · Orthopedic
Sep 2023
Decision
180d
Days
Class 2
Risk

About This 510(k) Submission

K230750 is an FDA 510(k) clearance for the OSSIOfiber? Cannulated Trimmable Fixation Nail, a Pin, Fixation, Smooth (Class II — Special Controls, product code HTY), submitted by OSSIO , Ltd. (Caesarea, IL). The FDA issued a Cleared decision on September 13, 2023, 180 days after receiving the submission on March 17, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K230750 FDA.gov
FDA Decision Cleared SESE
Date Received March 17, 2023
Decision Date September 13, 2023
Days to Decision 180 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code HTY — Pin, Fixation, Smooth
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3040

Similar Devices — HTY Pin, Fixation, Smooth

All 203
ZipToe? Hammertoe Fusion System
K253325 · Toetal Solutions · Dec 2025
Impact PEEK Union Nail System
K252657 · Nvision Biomedical Technologies, Inc. · Sep 2025
RONAVIS ? FX (FX-001)
K250315 · AIRS, Inc. · Aug 2025
PediFlex? Flexible Nail System
K251362 · OrthoPediatrics Corp. · Jun 2025
Impact PEEK Union Nail System
K250646 · Nvision Biomedical Technologies · Jun 2025
Biomet Kirschner Wires (K-Wires)
K241014 · Biomet, Inc. · May 2024