Cleared Traditional

K111432 - EVOLVE (R) TRIAD (TM) PLATING SYSTEM AND EVOLVE (R) TRIAD (TM) BONE SCREWS

K111432 is an FDA 510(k) clearance for EVOLVE TRIAD (TM) PLATING SYSTEM AND EV..., manufactured by Wrightmedicaltechnologyinc. The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K111432 · Wrightmedicaltechnologyinc · Orthopedic device
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Aug 2011
Decision
88d
Days
Class 2
Risk

K111432 is an FDA 510(k) clearance for the EVOLVE (R) TRIAD (TM) PLATING SYSTEM AND EVOLVE (R) TRIAD (TM) BONE SCREWS. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Wrightmedicaltechnologyinc (Arlington, US). The FDA issued a Cleared decision on August 19, 2011 after a review of 88 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 Wrightmedicaltechnologyinc devices

FDA 510(k) Submission Details - K111432

510(k) Number K111432 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 2011
Decision Date August 19, 2011
Days to Decision 88 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
34d faster than avg
Panel avg: 122d · This submission: 88d
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 1254
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K111432.
IFS PROFILE PLATES, SCREWS, AND WASHERS
K110086 · Internal Fixation Systems, Inc. · Sep 2011
SKELETAL DYNAMICS GEMINUS VOLAR DISTAL RADIUS PLATE MODEL STANDARD 3 HOLE RIGHT, STANDARD 3 HOLE LEFT, SKELETAL DYNAMICS
K111620 · Skeletal Dynamics, LLC · Aug 2011
TRIMED RADIOCARPAL FUSION SYSTEM
K102785 · TriMed, Inc. · Aug 2011
SYNTHES 3.5MM LCP CLAVICLE PLATE SYSTEM
K111540 · Synthes (Usa) · Aug 2011
ORTHOPEDIATRICS BLADE PLATE SYSTEM
K110959 · OrthoPediatrics Corp. · Aug 2011
ARTHREX DISTAL EXTREMITY PLATE SYSTEM
K111253 · Arthrex, Inc. · Aug 2011