Cleared Traditional

K150649 - G3 Active Plate Large Fragment System

K150649 is an FDA 510(k) clearance for G3 Active Plate Large Fragment System, manufactured by Genesis Fracture Care, Inc.. The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K150649 · Genesis Fracture Care, Inc. · Orthopedic device
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Apr 2015
Decision
49d
Days
Class 2
Risk

K150649 is an FDA 510(k) clearance for the G3 Active Plate Large Fragment System. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Genesis Fracture Care, Inc. (Clackamas, US). The FDA issued a Cleared decision on April 30, 2015 after a review of 49 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 Genesis Fracture Care, Inc. devices

FDA 510(k) Submission Details - K150649

510(k) Number K150649 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 2015
Decision Date April 30, 2015
Days to Decision 49 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
73d faster than avg
Panel avg: 122d · This submission: 49d
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 1034
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K150649.
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