Cleared Traditional

K233910 - Vertex Hip Fracture Nailing System

K233910 is an FDA 510(k) clearance for Vertex Hip Fracture Nailing System, manufactured by Orthoxel Dac. The device is a Class 2 Orthopedic device with product code HSB cleared through the Traditional 510(k) pathway after a 114-day FDA review.

K233910 · Orthoxel Dac · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2024
Decision
114d
Days
Class 2
Risk

K233910 is an FDA 510(k) clearance for the Vertex Hip Fracture Nailing System. Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by Orthoxel Dac (Cork, IE). The FDA issued a Cleared decision on April 4, 2024 after a review of 114 days - within the typical 510(k) review window.

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 Dac devices

FDA 510(k) Submission Details - K233910

510(k) Number K233910 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 2023
Decision Date April 04, 2024
Days to Decision 114 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
8d faster than avg
Panel avg: 122d · This submission: 114d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HSB Device Classification - Class 2, Special Controls

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 368
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K233910.
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