Cleared Traditional

K153482 - KLS Martin Thoracic Plating System

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

K153482 · KLS-Martin L.P. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K153482

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.

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 1245
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K153482.
Gridlock Ankle Plating System
K160177 · Trilliant Surgical, Ltd. · Apr 2016
MotoBand(TM) CP Implant System
K160300 · Crossroads Extremity Systems, LLC · Apr 2016
G3(TM) Active Plate(R) Small Fragment System
K160633 · Genesis Fracture Care, Inc. · Apr 2016
Align Anterior Ankle Fusion Plate
K160191 · Extremity Medical, LLC · Mar 2016
Biomet Microfixation RibFix Blu Thoracic Fixation System
K152253 · Biomet Microfixation · Mar 2016
Piccolo Composite(R) Distal Volar Radius Plate System
K160002 · CarboFix Orthopedics , Ltd. · Mar 2016