Cleared Traditional

K150099 - Depuy Synthes Variable Angle Locking Hand System (1.3 mm and 2.0 mm Plates and Screws)

K150099 is an FDA 510(k) clearance for Depuy Synthes Variable Angle Locking Ha..., manufactured by Synthes USA Products, LLC. The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K150099 · Synthes USA Products, LLC · Orthopedic device
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Mar 2015
Decision
62d
Days
Class 2
Risk

K150099 is an FDA 510(k) clearance for the Depuy Synthes Variable Angle Locking Hand System (1.3 mm and 2.0 mm Plates an.... Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Synthes USA Products, LLC (West Chester, US). The FDA issued a Cleared decision on March 23, 2015 after a review of 62 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 Synthes USA Products, LLC devices

FDA 510(k) Submission Details - K150099

510(k) Number K150099 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 20, 2015
Decision Date March 23, 2015
Days to Decision 62 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
60d faster than avg
Panel avg: 122d · This submission: 62d
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 1242
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K150099.
Eminent Foot Plate System
K143365 · Eminent Spine · Mar 2015
Biomet Proximal Humerus Plating System
K143697 · Biomet Manufacturing · Mar 2015
Tarsa-Link Wedge Fixation System
K150368 · Life Spine · Mar 2015
PROXIMAL HUMERUS PLATING SYSTEM
K141493 · Miami Device Solutions · Mar 2015
Treace Medical Concepts(TMC) Plating System
K143717 · Treace Medical Concepts, Inc. · Mar 2015
Zimmer Plates and Screws System (ZPS) - Non-sterile ZPS
K143331 · Zimmer, Inc. · Mar 2015