Cleared Traditional

K113718 - NCB STRAIGHT NARROW SHAFT PLATES

K113718 is an FDA 510(k) clearance for NCB STRAIGHT NARROW SHAFT PLATES, manufactured by Zimmer GmbH. The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 39-day FDA review.

K113718 · Zimmer GmbH · Orthopedic device
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Jan 2012
Decision
39d
Days
Class 2
Risk

K113718 is an FDA 510(k) clearance for the NCB STRAIGHT NARROW SHAFT PLATES. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Zimmer GmbH (Warsaw, US). The FDA issued a Cleared decision on January 27, 2012 after a review of 39 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 Zimmer GmbH devices

FDA 510(k) Submission Details - K113718

510(k) Number K113718 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 2011
Decision Date January 27, 2012
Days to Decision 39 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
83d faster than avg
Panel avg: 122d · This submission: 39d
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 1237
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K113718.
CHECKMATE METATARSO-PHALANGEAL (MTP) ARTHRODESIS SYSTEM
K113762 · Arthrosurface, Inc. · Feb 2012
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K113014 · Wrightmedicaltechnologyinc · Jan 2012
MAXLOCK EXTREME SYSTEM
K113048 · Orthohelix Surgical Designs, Inc. · Jan 2012
ACUTE INNOVATIONS MODULAR RIBLOC SYSTEM
K113318 · Acute Innovations, LLC · Jan 2012
SUSPENSION CLAVICLE FRACTURE REPAIR SYSTEM
K113405 · Suspension Orthopaedic Solutions, LLC · Jan 2012
APTUS WRIST ARTHRODESIS PLATES
K112169 · Medartis AG · Jan 2012