Cleared Traditional

K170972 - Apex Tibial Nailing System

K170972 is the FDA 510(k) clearance for Apex Tibial Nailing System by Orthoxel. It is a Class 2 Orthopedic device (product code HSB) cleared through the Traditional 510(k) pathway after a 261-day FDA review.

K170972 · Orthoxel · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2017
Decision
261d
Days
Class 2
Risk

K170972 is an FDA 510(k) clearance for the Apex Tibial Nailing System. Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by Orthoxel (Bishopstown, IE). The FDA issued a Cleared decision on December 20, 2017 after a review of 261 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3020 - 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 Orthoxel devices

Submission Details

510(k) Number K170972 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 2017
Decision Date December 20, 2017
Days to Decision 261 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
139d slower than avg
Panel avg: 122d · This submission: 261d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HSB Rod, Fixation, Intramedullary And Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3020
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 - HSB Rod, Fixation, Intramedullary And Accessories

All 331
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K170972.
T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN Instruments System
K172774 · Stryker Trauma GmbH · Jan 2018
AUTOBAHN Nailing System
K171108 · Globus Medical, Inc. · Dec 2017
Piccolo Composite Nailing System
K173652 · CarboFix Orthopedics , Ltd. · Dec 2017
ORTHOFIX CHIMAERA Hip Fracture System - Trochanteric Nailing System
K173458 · Orthofix Srl · Dec 2017
DePuy Synthes Femoral Recon Nail System
K172157 · Synthes USA Products, LLC · Nov 2017
Shotel Ankle Arthrodesis Nail System
K163627 · Biopro, Inc. · Sep 2017