Cleared Traditional

K131480 - EMERGE MEDICAL LOCKING ONE-THIRD TUBULA...

K131480 is an FDA 510(k) clearance for EMERGE MEDICAL LOCKING ONE-THIRD TUBULA..., 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 42-day FDA review.

K131480 · Emerge Medical · Orthopedic device
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Jul 2013
Decision
42d
Days
Class 2
Risk

K131480 is an FDA 510(k) clearance for the EMERGE MEDICAL LOCKING ONE-THIRD TUBULAR PLATE 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 Emerge Medical (Denver, US). The FDA issued a Cleared decision on July 3, 2013 after a review of 42 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 Emerge Medical devices

FDA 510(k) Submission Details - K131480

510(k) Number K131480 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 2013
Decision Date July 03, 2013
Days to Decision 42 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
80d faster than avg
Panel avg: 122d · This submission: 42d
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 1046
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K131480.
ACUMED WRIST SPANNING PLATE
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ARTHREX DISTAL RADIUS PLATE SYSTEM
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LAPIDUS PLATE, 3.5MM INLINE FUSION PLATE, 3.5MM MTP PLATE (LEFT AND RIGHT)
K131670 · Biomet, Inc. · Jul 2013
UNIVERSAL DISTAL RADIUS SYSTEM
K130774 · Newclip Technics · Jun 2013
OSTEOMED EXTREMILOCK FOOT PLATING SYSTEM
K131445 · Osteomed LP · Jun 2013