Cleared Traditional

K132733 - ORTHOHELIX SYNDESMOSIS FIXATION DEVICES

K132733 is an FDA 510(k) clearance for ORTHOHELIX SYNDESMOSIS FIXATION DEVICES, manufactured by Orthohelix Surgical Designs, Inc.. The device is a Class 2 Orthopedic device with product code HTN cleared through the Traditional 510(k) pathway after a 122-day FDA review.

K132733 · Orthohelix Surgical Designs, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2014
Decision
122d
Days
Class 2
Risk

K132733 is an FDA 510(k) clearance for the ORTHOHELIX SYNDESMOSIS FIXATION DEVICES. Classified as Washer, Bolt Nut (product code HTN), Class II - Special Controls.

Submitted by Orthohelix Surgical Designs, Inc. (Medina, US). The FDA issued a Cleared decision on January 3, 2014 after a review of 122 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - 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 Orthohelix Surgical Designs, Inc. devices

FDA 510(k) Submission Details - K132733

510(k) Number K132733 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 2013
Decision Date January 03, 2014
Days to Decision 122 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
At panel average
Panel avg: 122d · This submission: 122d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HTN Device Classification - Class 2, Special Controls

Product Code HTN Washer, Bolt Nut
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
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 - HTN Washer, Bolt Nut

All 69
Devices cleared under the same product code (HTN) and FDA review panel - the closest regulatory comparables to K132733.
ARTHROSURFACE KISSLOC KNOTLESS SUTURE SYSTEM
K133835 · Arthrosurface, Inc. · Jul 2014
CMC MINI TIGHTROPE
K140328 · Arthrex, Inc. · Mar 2014
MINI TIGHTROPE
K133275 · Arthrex, Inc. · Jan 2014
BIOPRO - INFINITY PLATE ANCHOR SYSTEM
K132510 · Biopro, Inc. · Oct 2013
FRAG-LOC SYSTEM
K130986 · Acumed, LLC · Jul 2013
ARTHREX FRACTURE SYSTEM
K112437 · Arthrex, Inc. · Dec 2011