Cleared Traditional

K142943 - Metallic Locking Bone Plate and Screw

K142943 is an FDA 510(k) clearance for Metallic Locking Bone Plate and Screw, manufactured by Canwell Medical Co., Ltd.. The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 297-day FDA review.

K142943 · Canwell Medical Co., Ltd. · Orthopedic device
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Aug 2015
Decision
297d
Days
Class 2
Risk

K142943 is an FDA 510(k) clearance for the Metallic Locking Bone Plate and Screw. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Canwell Medical Co., Ltd. (Jinhua, CN). The FDA issued a Cleared decision on August 3, 2015 after a review of 297 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 Canwell Medical Co., Ltd. devices

FDA 510(k) Submission Details - K142943

510(k) Number K142943 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 10, 2014
Decision Date August 03, 2015
Days to Decision 297 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
175d slower than avg
Panel avg: 122d · This submission: 297d
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 Consultant

Osmunda Medical Device Consulting Co., Ltd.
Mike Gu

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - HRS Plate, Fixation, Bone

All 1310
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K142943.
WASTON Metallic Bone Plate and Screw Systems
K151057 · Changzhou Waston Medical Appliance Co., Ltd. · Aug 2015
Medline Foot Plates and Screws
K151235 · Medline Industries, Inc. · Aug 2015
VariAx 2 One-Third Tubular Plating System
K151879 · Stryker GmbH · Aug 2015
AUXEIN BRAND OF Bone Plates and Bone Screws & AUXEIN Brand of DCS Plate System AUXEIN brand of Locking Plates and Locking Screws
K141680 · Auxein Medical · Jun 2015
VariAx 2 Wrist Fusion System
K151178 · Stryker Trauma AG · Jun 2015
APTUS Wrist 2.5 System
K142906 · Medartis AG · Jun 2015