Cleared Traditional

K140107 - EMERGE MEDICAL DISTAL RADIUS SET

K140107 is an FDA 510(k) clearance for EMERGE MEDICAL DISTAL RADIUS SET, manufactured by Emerge Medical. The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K140107 · Emerge Medical · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2014
Decision
57d
Days
Class 2
Risk

K140107 is an FDA 510(k) clearance for the EMERGE MEDICAL DISTAL RADIUS SET. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Emerge Medical (Colorado Springs, US). The FDA issued a Cleared decision on March 13, 2014 after a review of 57 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 - K140107

510(k) Number K140107 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 15, 2014
Decision Date March 13, 2014
Days to Decision 57 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
65d faster than avg
Panel avg: 122d · This submission: 57d
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 1312
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K140107.
VARIAX CLAVICLE HOOK PLATE
K140259 · Stryker Trauma AG · Apr 2014
FLOWER REAR FOOT PLATING SET, FLOWER CALCANEUS PLANTING SET, FLOWER REARFOOT PLATING SET
K133930 · Flower Orthopedics Corporation · Mar 2014
VARIAX DISTAL RADIUS PLATING SYSTEM
K133974 · Stryker Leibinger GmbH · Mar 2014
EMERGE MEDICAL SMALL FRAGMENT LOCKED PLATING SYSTEM
K140098 · Emerge Medical · Mar 2014
EMERGE MEDICAL PERIARTICULAR AND LOCKING LARGE FRAGMENT SYSTEM
K140119 · Emerge Medical · Mar 2014
LOCKING COMPRESSION BONE PLATES AND SCREW SYSTEM
K133525 · Changzhou Dean Medical Instrument Co, Ltd. · Mar 2014