Cleared Traditional

K150009 - Baide

K150009 is an FDA 510(k) clearance for Baide, manufactured by Jiangsu Baide Medical Intrument Co., Ltd.. The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 54-day FDA review.

K150009 · Jiangsu Baide Medical Intrument Co., Ltd. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2015
Decision
54d
Days
Class 2
Risk

K150009 is an FDA 510(k) clearance for the Baide. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Jiangsu Baide Medical Intrument Co., Ltd. (Zhangjiagang City, CN). The FDA issued a Cleared decision on February 25, 2015 after a review of 54 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.

FDA 510(k) Submission Details - K150009

510(k) Number K150009 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 02, 2015
Decision Date February 25, 2015
Days to Decision 54 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
68d faster than avg
Panel avg: 122d · This submission: 54d
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

Shanghai Yarui Consultant Co., Ltd.
Alice Gong

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 K150009.
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Zimmer Periarticular Plating System
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HIGH TIBIAL OSTEOTOMY SYSTEM
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Activ Ankle Locking Plating System
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