Cleared Traditional

K181640 - X-BOLT Hip Fracture Fixation System (FDA 510(k) Clearance)

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

K181640 · X-Bolt Orthopaedics · Orthopedic device
Oct 2018
Decision
113d
Days
Class 2
Risk

K181640 is an FDA 510(k) clearance for the X-BOLT Hip Fracture Fixation System. Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by X-Bolt Orthopaedics (Dublin, IE). The FDA issued a Cleared decision on October 12, 2018 after a review of 113 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.

Submission Details

510(k) Number K181640 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 2018
Decision Date October 12, 2018
Days to Decision 113 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
3d faster than avg
Panel avg: 116d · This submission: 113d
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 42
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K181640.
Arthrex Humeral Nails
K252016 · Arthrex, Inc. · Mar 2026
Fusion FibFix Nail
K252961 · Fusion Orthopedics USA, LLC · Mar 2026
Affixus Retrograde Femoral Nailing System
K253566 · Zimmer, Inc. · Mar 2026
Reselute Tibial Nail
K253517 · Reselute, Inc. · Mar 2026
Arthrex FibuLock Nail System
K252196 · Arthrex, Inc. · Mar 2026
Phantom® Hindfoot TTC/TC Nail System
K253591 · Paragon 28, Inc. · Mar 2026