Cleared Traditional

K132900 - MARAUDER CERVICAL-THORACIC SPINAL FIXAT...

K132900 is an FDA 510(k) clearance for MARAUDER CERVICAL-THORACIC SPINAL FIXAT..., manufactured by Intelligent Implant Systems, LLC. The device is a Class 2 Orthopedic device with product code KWP cleared through the Traditional 510(k) pathway after a 39-day FDA review.

K132900 · Intelligent Implant Systems, LLC · Orthopedic device
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Oct 2013
Decision
39d
Days
Class 2
Risk

K132900 is an FDA 510(k) clearance for the MARAUDER CERVICAL-THORACIC SPINAL FIXATION SYSTEM. Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by Intelligent Implant Systems, LLC (Charlotte, US). The FDA issued a Cleared decision on October 25, 2013 after a review of 39 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3050 - 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 Intelligent Implant Systems, LLC devices

FDA 510(k) Submission Details - K132900

510(k) Number K132900 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 2013
Decision Date October 25, 2013
Days to Decision 39 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
83d faster than avg
Panel avg: 122d · This submission: 39d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KWP Device Classification - Class 2, Special Controls

Product Code KWP Appliance, Fixation, Spinal Interlaminal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3050
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 - KWP Appliance, Fixation, Spinal Interlaminal

All 327
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K132900.
SYNAPSE SYSTEM
K133698 · Synthes USA Products, LLC · Jan 2014
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K133094 · X-Spine Systems, Inc. · Dec 2013
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K132504 · Corelink, LLC · Nov 2013
LOTUS
K131427 · Spinal Elements, Inc. · Oct 2013
MOUNTAINEER OCT SPINAL SYSTEM
K132332 · Medos International SARL · Aug 2013
LANX SPINAL FIXATION SYSTEM
K131156 · Lanx, Inc. · May 2013