Cleared Traditional

OSSIOfiber® Threaded Trimmable Fixation Nails (K233198) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K233198 · OSSIO , Ltd. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2024
Decision
162d
Days
Class 2
Risk

K233198 is an FDA 510(k) clearance for the OSSIOfiber® Threaded Trimmable Fixation Nails. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by OSSIO , Ltd. (Caesarea, IL). The FDA issued a Cleared decision on March 8, 2024 after a review of 162 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all OSSIO , Ltd. devices

Submission Details

510(k) Number K233198 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2023
Decision Date March 08, 2024
Days to Decision 162 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
40d slower than avg
Panel avg: 122d · This submission: 162d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HWC Screw, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - HWC Screw, Fixation, Bone

All 406
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K233198.
Cannulated Headless Bone Screws
K233008 · Aap Implantate AG · Jun 2024
DynaNail Mini Tapered Hybrid
K240530 · MedShape, Inc. · Mar 2024
ARIX Cannulated Screw System
K233912 · Jeil Medical Corporation · Mar 2024
SnapHammer Hammertoe Correction System
K231453 · Nvision Biomedical Technologies, Inc. · Feb 2024
TDM Screw System
K231860 · Tdm Co., Ltd. · Jan 2024
TriMed Threaded Intramedullary Nail System
K234040 · TriMed, Inc. · Jan 2024