Cleared Traditional

K181640 - X-BOLT Hip Fracture Fixation System

K181640 is the FDA 510(k) clearance for X-BOLT Hip Fracture Fixation System by X-Bolt Orthopaedics. It is a Class 2 Orthopedic device (product code HSB) cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K181640 · X-Bolt Orthopaedics · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

View all X-Bolt Orthopaedics devices

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
9d faster than avg
Panel avg: 122d · 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 Consultant

Musculoskeletal Clinical Regulatory Advisers, LLC
Brian Thornes

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - HSB Rod, Fixation, Intramedullary And Accessories

All 330
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K181640.
Affixus Hip Fracture Nail
K183162 · Biomet, Inc. · Dec 2018
Panta 2 Arthrodesis Nail System
K181639 · Integra LifeSciences Corporation · Nov 2018
OsteoBridge™ IDSF System
K181026 · Merete GmbH · Oct 2018
Double Medical Femoral Nail System
K172830 · Double Medical Technology, Inc. · Aug 2018
OIC Intramedullary Nail System
K181184 · The Orthopaedic Implant Company · Jul 2018
Arthrex FibuLock Nail
K173656 · Arthrex, Inc. · Jul 2018