Cleared Traditional

HIGH TIBIAL OSTEOTOMY SYSTEM (K141548) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K141548 · Newclip Technics · Orthopedic device
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Jan 2015
Decision
233d
Days
Class 2
Risk

K141548 is an FDA 510(k) clearance for the HIGH TIBIAL OSTEOTOMY 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 Newclip Technics (Round Rock, US). The FDA issued a Cleared decision on January 30, 2015 after a review of 233 days - an extended review 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: 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 Newclip Technics devices

Submission Details

510(k) Number K141548 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 11, 2014
Decision Date January 30, 2015
Days to Decision 233 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
111d slower than avg
Panel avg: 122d · This submission: 233d
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 696
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K141548.
DEPUY SYNTHES VARIABLE ANGLE LOCKING HAND SYSTEM
K141527 · Synthes (Usa) · Mar 2015
Zimmer Plates and Screws System (ZPS) - Non-sterile ZPS
K143331 · Zimmer, Inc. · Mar 2015
Zimmer Periarticular Plating System
K150121 · Zimmer, Inc. · Feb 2015
Arthrex Fracture System
K143139 · Arthrex, Inc. · Jan 2015
VLP Mini-Mod Small Bone Plating System 1.5mm Plates and Screws
K143050 · Smith & Nephew, Inc. · Dec 2014
TOTAL COMPRESSION PLATING SYSTEM
K143025 · Wrightmedicaltechnologyinc · Dec 2014