Cleared Traditional

K133541 - EMERGE MEDICAL SMALL AND LARGE NON-LOCK...

K133541 is an FDA 510(k) clearance for EMERGE MEDICAL SMALL AND LARGE NON-LOCK..., 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 71-day FDA review.

K133541 · Emerge Medical · Orthopedic device
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Jan 2014
Decision
71d
Days
Class 2
Risk

K133541 is an FDA 510(k) clearance for the EMERGE MEDICAL SMALL AND LARGE NON-LOCKING FRAGMENT 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 January 28, 2014 after a review of 71 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 - K133541

510(k) Number K133541 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 2013
Decision Date January 28, 2014
Days to Decision 71 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
51d faster than avg
Panel avg: 122d · This submission: 71d
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 K133541.
CHARLOTTE CLAW PLATE SYSTEM
K133715 · Wrightmedicaltechnologyinc · Feb 2014
EXTRIMILOCK ANKLE PLATING SYSTEM
K133691 · Osteomed LP · Feb 2014
SMITH & NEPHEW VARIABLE-ANGLE LOCKING MINI-FRAGMENT PLATING SYSTEM
K132886 · Smith & Nephew, Inc. · Feb 2014
AAP LOQTEQ DISTAL ANTEROLATERAL TIBIA PLATE 3.5
K133675 · Aap Implantate AG · Jan 2014
D-RAD SMART PACK
K132296 · Smith & Nephew, Inc. · Jan 2014
ACUMED HAND PLATING SYSTEM
K132769 · Acumed, LLC · Jan 2014