Cleared Traditional

K142418 - I.T.S. Hand Locking Plates System - HLS

K142418 is an FDA 510(k) clearance for I.T.S. Hand Locking Plates System - HLS, manufactured by I.T.S. GmbH. The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K142418 · I.T.S. GmbH · Orthopedic device
Download Printable Device Report (PDF)
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Sep 2014
Decision
29d
Days
Class 2
Risk

K142418 is an FDA 510(k) clearance for the I.T.S. Hand Locking Plates System - HLS. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by I.T.S. GmbH (Lassinitzhoehe/Graz, AT). The FDA issued a Cleared decision on September 26, 2014 after a review of 29 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all I.T.S. GmbH devices

FDA 510(k) Submission Details - K142418

510(k) Number K142418 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 2014
Decision Date September 26, 2014
Days to Decision 29 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
93d faster than avg
Panel avg: 122d · This submission: 29d
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 Consultant

Engineering Consulting Services, Inc.
Al Lippincott

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - HRS Plate, Fixation, Bone

All 1305
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K142418.
Sternal Closure System
K142484 · Jace Medical, LLC · Oct 2014
Zimmer Periarticular Plating System
K142579 · Zimmer, Inc. · Oct 2014
PRO-LINK WEDGE SYSTEM
K141905 · Life Spine · Sep 2014
Flower Upper Extremity Plating Set
K142306 · Flower Orthopedics Corporation · Sep 2014
DEPUY SYNTHES TOMOFIX OSTEOTOMY SYSTEM
K141796 · Synthes USA Products, LLC · Aug 2014
DISTAL ELBOW PLATING SYSTEM
K140892 · Skeletal Dynamics, LLC · Aug 2014