Cleared Traditional

K143025 - TOTAL COMPRESSION PLATING SYSTEM

K143025 is an FDA 510(k) clearance for TOTAL COMPRESSION PLATING SYSTEM, manufactured by Wrightmedicaltechnologyinc. The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K143025 · Wrightmedicaltechnologyinc · Orthopedic device
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Dec 2014
Decision
45d
Days
Class 2
Risk

K143025 is an FDA 510(k) clearance for the TOTAL COMPRESSION 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 Wrightmedicaltechnologyinc (Memphis, US). The FDA issued a Cleared decision on December 5, 2014 after a review of 45 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 - K143025

510(k) Number K143025 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 2014
Decision Date December 05, 2014
Days to Decision 45 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
77d faster than avg
Panel avg: 122d · This submission: 45d
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 K143025.
AxSOS 3 Ti Locking Plate System
K143138 · Stryker Trauma AG · Dec 2014
VLP Mini-Mod Small Bone Plating System 1.5mm Plates and Screws
K143050 · Smith & Nephew, Inc. · Dec 2014
Mini and Micro Fragments Reconstruction System-NEOFIX
K142419 · Neoortho Productos Orthopedicos S/A · Dec 2014
Zimmer Plates and Screws (ZPS) - Non Sterile Plate Line Extensions, Sterile/Non-Sterile ZPS / Screws and Washers
K143066 · Zimmer, Inc. · Nov 2014
G3 Active Plate Large Fragment System
K142938 · Genesis Fracture Care, Inc. · Nov 2014
Zimmer Plates and Screws (ZPS), Forte Screws
K142836 · Zimmer, Inc. · Nov 2014