Cleared Traditional

K143523 - Airlock osteosynthesis plate system

K143523 is an FDA 510(k) clearance for Airlock osteosynthesis plate system, manufactured by Novastep. The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 115-day FDA review.

K143523 · Novastep · Orthopedic device
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Apr 2015
Decision
115d
Days
Class 2
Risk

K143523 is an FDA 510(k) clearance for the Airlock osteosynthesis plate system. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Novastep (Saint Gregoire, FR). The FDA issued a Cleared decision on April 6, 2015 after a review of 115 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - 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 - K143523

510(k) Number K143523 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 2014
Decision Date April 06, 2015
Days to Decision 115 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
7d faster than avg
Panel avg: 122d · This submission: 115d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HRS Device Classification - Class 2, Special Controls

Product Code HRS Plate, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
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 - HRS Plate, Fixation, Bone

All 1006
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K143523.
DARCO Locking Bone Plate System
K150520 · Wrightmedicaltechnologyinc · Apr 2015
APTUS Foot System
K142581 · Medartis AG · Apr 2015
Acumed Ankle Plating System
K143385 · Acumed, LLC · Apr 2015
Arthrex Distal Radius System
K143749 · Arthrex, Inc. · Apr 2015
DEPUY SYNTHES VARIABLE ANGLE LOCKING HAND SYSTEM
K141527 · Synthes (Usa) · Mar 2015
Tarsa-Link Wedge Fixation System
K150368 · Life Spine · Mar 2015