Cleared Traditional

K130340 - LOCKING BONE PLATES AND SCREWS

K130340 is an FDA 510(k) clearance for LOCKING BONE PLATES AND SCREWS, manufactured by Weigao Orthopaedic Device Co., Ltd.. The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 53-day FDA review.

K130340 · Weigao Orthopaedic Device Co., Ltd. · Orthopedic device
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Apr 2013
Decision
53d
Days
Class 2
Risk

K130340 is an FDA 510(k) clearance for the LOCKING BONE PLATES AND 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 Weigao Orthopaedic Device Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on April 5, 2013 after a review of 53 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 Weigao Orthopaedic Device Co., Ltd. devices

FDA 510(k) Submission Details - K130340

510(k) Number K130340 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 11, 2013
Decision Date April 05, 2013
Days to Decision 53 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
69d faster than avg
Panel avg: 122d · This submission: 53d
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 1046
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K130340.
PELVIS II IMPLANT SYSTEM
K131132 · Stryker Trauma AG · May 2013
ORTHOLOC(R) 3DI ANKLE PLATING SYSTEM
K131093 · Wrightmedicaltechnologyinc · May 2013
ARTHREX FRACTURE PLATES
K123241 · Arthrex, Inc. · Apr 2013
BIOMET RECONSTRUCTIVE WEDGES MODEL 110003660-99, 110003797-831
K122770 · Biomet Manufacturing Corp · Mar 2013
AXSOS 3 TI LOCKING PLATE SYSTEM
K123964 · Stryker Trauma AG · Mar 2013
VARIAX 2 COMPRESSION PLATING SYSTEM
K130009 · Stryker Trauma AG · Mar 2013