Cleared Traditional

K143049 - LYNC intramedullary implant

K143049 is an FDA 510(k) clearance for LYNC intramedullary implant, manufactured by Novastep. The device is a Class 2 Orthopedic device with product code HTY cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K143049 · Novastep · Orthopedic device
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Feb 2015
Decision
119d
Days
Class 2
Risk

K143049 is an FDA 510(k) clearance for the LYNC intramedullary implant. Classified as Pin, Fixation, Smooth (product code HTY), Class II - Special Controls.

Submitted by Novastep (Saint Gregoire, FR). The FDA issued a Cleared decision on February 19, 2015 after a review of 119 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - 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 Novastep devices

FDA 510(k) Submission Details - K143049

510(k) Number K143049 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 2014
Decision Date February 19, 2015
Days to Decision 119 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
3d faster than avg
Panel avg: 122d · This submission: 119d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HTY Device Classification - Class 2, Special Controls

Product Code HTY Pin, Fixation, Smooth
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
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 - HTY Pin, Fixation, Smooth

All 108
Devices cleared under the same product code (HTY) and FDA review panel - the closest regulatory comparables to K143049.
Rush Medullary Pins
K150626 · Zimmer, Inc. · May 2015
ProCinch Adjustable Loop Device
K150416 · Stryker Endoscopy · Apr 2015
Arthrex Blunt Tip Screws with Fiber Tape
K143702 · Arthrex, Inc. · Apr 2015
Kirschner Wires, Steinmann Pins
K143618 · Zimmer, Inc. · Feb 2015
PRO-TOE X-FLEX HAMMERTOE FIXATION SYSTEM
K141714 · Wrightmedicaltechnologyinc · Oct 2014
INTRAOSSEOUS FIXATION SYSTEM
K141004 · Orthohelix Surgical Designs, Inc. · Aug 2014