Cleared Traditional

K120165 - INTRAOSSEOUS FIXATION SYSTEM (FDA 510(k) Clearance)

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

K120165 · Orthohelix Surgical Designs, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2012
Decision
89d
Days
Class 2
Risk

K120165 is an FDA 510(k) clearance for the INTRAOSSEOUS FIXATION SYSTEM. Classified as Pin, Fixation, Smooth (product code HTY), Class II - Special Controls.

Submitted by Orthohelix Surgical Designs, Inc. (Medina, US). The FDA issued a Cleared decision on April 17, 2012 after a review of 89 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Orthohelix Surgical Designs, Inc. devices

Submission Details

510(k) Number K120165 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 19, 2012
Decision Date April 17, 2012
Days to Decision 89 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
33d faster than avg
Panel avg: 122d · This submission: 89d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HTY Pin, Fixation, Smooth
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 - HTY Pin, Fixation, Smooth

All 203
Devices cleared under the same product code (HTY) and FDA review panel - the closest regulatory comparables to K120165.
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