Cleared Traditional

K163488 - Flex-Thread Clavicle Pin System

K163488 is an FDA 510(k) clearance for Flex-Thread Clavicle Pin System, manufactured by Intrafuse, LLC. The device is a Class 2 Orthopedic device with product code HSB cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K163488 · Intrafuse, LLC · Orthopedic device
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Mar 2017
Decision
98d
Days
Class 2
Risk

K163488 is an FDA 510(k) clearance for the Flex-Thread Clavicle Pin System. Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by Intrafuse, LLC (Logan, US). The FDA issued a Cleared decision on March 20, 2017 after a review of 98 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 Intrafuse, LLC devices

FDA 510(k) Submission Details - K163488

510(k) Number K163488 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 2016
Decision Date March 20, 2017
Days to Decision 98 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
24d faster than avg
Panel avg: 122d · This submission: 98d
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 379
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K163488.
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PRECICE Intramedullary Limb Lengthening System
K170346 · Nuvasive Specialized Orthopedics, Inc. · Mar 2017
ORTHOFIX CHIMAERA Hip Fracture System - Trochanteric Nailing System
K161466 · Orthofix Srl · Jan 2017
TRIGEN Low Profile Bone Screws
K161264 · Smith & Nephew, Inc. · Nov 2016