Cleared Traditional

K151057 - WASTON Metallic Bone Plate and Screw Systems

K151057 is an FDA 510(k) clearance for WASTON Metallic Bone Plate and Screw Sy..., manufactured by Changzhou Waston Medical Appliance Co., Ltd.. The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K151057 · Changzhou Waston Medical Appliance Co., Ltd. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2015
Decision
112d
Days
Class 2
Risk

K151057 is an FDA 510(k) clearance for the WASTON Metallic Bone Plate and Screw Systems. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Changzhou Waston Medical Appliance Co., Ltd. (Changzhou, CN). The FDA issued a Cleared decision on August 10, 2015 after a review of 112 days - within the typical 510(k) review window.

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 Changzhou Waston Medical Appliance Co., Ltd. devices

FDA 510(k) Submission Details - K151057

510(k) Number K151057 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 2015
Decision Date August 10, 2015
Days to Decision 112 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
10d faster than avg
Panel avg: 122d · This submission: 112d
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

Mid-Link Consulting Co, Ltd.
Diana Hong

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 1312
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K151057.
Airlock® osteosynthesis plate system
K151277 · Novastep · Aug 2015
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RECON system
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Medline Foot Plates and Screws
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VariAx 2 One-Third Tubular Plating System
K151879 · Stryker GmbH · Aug 2015
Metallic Locking Bone Plate and Screw
K142943 · Canwell Medical Co., Ltd. · Aug 2015