Cleared Traditional

K014155 - OPENING/CLOSING WEDGE OSTETOMY PLATES

K014155 is the FDA 510(k) clearance for OPENING/CLOSING WEDGE OSTETOMY PLATES by Arthrex, Inc.. It is a Class 2 Orthopedic device (product code HRS) cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K014155 · Arthrex, Inc. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Mar 2002
Decision
89d
Days
Class 2
Risk

K014155 is an FDA 510(k) clearance for the OPENING/CLOSING WEDGE OSTETOMY PLATES. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Arthrex, Inc. (Naples, US). The FDA issued a Cleared decision on March 18, 2002 after a review of 89 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 Arthrex, Inc. devices

Submission Details

510(k) Number K014155 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 2001
Decision Date March 18, 2002
Days to Decision 89 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
33d faster than avg
Panel avg: 122d · This submission: 89d
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 907
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K014155.
IQL BASIC FRAGMENT PLATE SET, IQL BASIC FRAGMENT SCREW SET, IQL SMALL FRAGMENT SET, IQL MINI FRAGMENT SET
K020221 · Biomet Orthopedics, Inc. · Apr 2002
UNIVERSAL BONE PLATE III SYSTEM (UBP III)
K020611 · Spinal Concepts, Inc. · Mar 2002
SYNTHES HIGH TIBIAL OSTEOTOMY PLATE
K014197 · Synthes (Usa) · Mar 2002
SYNTHES ANKLE ARTHRODESIS PLATE
K013415 · Synthes (Usa) · Jan 2002
LORENZ LACTOSORB PANELS AND FASTENERS
K011139 · Biomet, Inc. · Dec 2001
SYNTHES LCP DISTAL TIBIA PLATES
K013248 · Synthes (Usa) · Dec 2001