Cleared Traditional

TRAUSON BONE PLATE (K073432) - FDA 510(k) Clearance

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

K073432 · Trauson (Jiangsu) Medical Instrument Co., Ltd. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2008
Decision
251d
Days
Class 2
Risk

K073432 is an FDA 510(k) clearance for the TRAUSON BONE PLATE. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Trauson (Jiangsu) Medical Instrument Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on August 13, 2008 after a review of 251 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 Trauson (Jiangsu) Medical Instrument Co., Ltd. devices

Submission Details

510(k) Number K073432 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 2007
Decision Date August 13, 2008
Days to Decision 251 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
129d slower than avg
Panel avg: 122d · This submission: 251d
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 K073432.
CHARLOTTE LISFRANC BONE SCREW, CHARLOTTE LISFRANC PLATE
K081374 · Wrightmedicaltechnologyinc · Sep 2008
SYNTHES RIB FIXATION SYSTEM
K081623 · Synthes (Usa) · Sep 2008
SMALL BONE LOCKING PLATING SYSTEM
K081546 · DePuy Orthopaedics, Inc. · Aug 2008
SYNTHES (USA) TOMOFIX MEDIAL DISTAL FEMUR PLATES
K081353 · Synthes (Usa) · Jul 2008
ORTHOMESH
K073115 · Synthes (Usa) · Jul 2008
EVOLVE EPS SYSTEM
K081373 · Wrightmedicaltechnologyinc · Jul 2008