Cleared Traditional

K153482 - KLS Martin Thoracic Plating System

K153482 is the FDA 510(k) clearance for KLS Martin Thoracic Plating System by KLS-Martin L.P.. It is a Class 2 Orthopedic device (product code HRS) cleared through the Traditional 510(k) pathway after a 125-day FDA review.

K153482 · KLS-Martin L.P. · Orthopedic device
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Apr 2016
Decision
125d
Days
Class 2
Risk

K153482 is an FDA 510(k) clearance for the KLS Martin Thoracic Plating 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 KLS-Martin L.P. (Jacksonville, US). The FDA issued a Cleared decision on April 6, 2016 after a review of 125 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 KLS-Martin L.P. devices

Submission Details

510(k) Number K153482 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 2015
Decision Date April 06, 2016
Days to Decision 125 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
3d slower than avg
Panel avg: 122d · This submission: 125d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 916
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K153482.
ARIX Foot System
K161864 · Jeil Medical Corporation · Aug 2016
AxSOS 3Ti
K153379 · Stryker GmbH · May 2016
BIOFOAM Bone Wedge
K152062 · Wrightmedicaltechnologyinc · May 2016
Piccolo Composite(R) Distal Volar Radius Plate System
K160002 · CarboFix Orthopedics , Ltd. · Mar 2016
TriMed Humeral Supracondylar Fixation System
K151735 · TriMed, Inc. · Jan 2016
Cable-Ready Cable Grip System: Cable-Ready Bone Plate System
K151716 · Zimmer, Inc. · Jan 2016