Cleared Special

K112611 - SINTEA PLUSTEK PLS MULTI-AXIAL SCREWS

K112611 is an FDA 510(k) clearance for SINTEA PLUSTEK PLS MULTI-AXIAL SCREWS, manufactured by Sintea Plastek, LLC. The device is a Class 2 Orthopedic device with product code MNI cleared through the Special 510(k) pathway after a 231-day FDA review.

K112611 · Sintea Plastek, LLC · Orthopedic device
Download Printable Device Report (PDF)
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Apr 2012
Decision
231d
Days
Class 2
Risk

K112611 is an FDA 510(k) clearance for the SINTEA PLUSTEK PLS MULTI-AXIAL SCREWS. Classified as Orthosis, Spinal Pedicle Fixation (product code MNI), Class II - Special Controls.

Submitted by Sintea Plastek, LLC (Miami Beach, US). The FDA issued a Cleared decision on April 25, 2012 after a review of 231 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3070 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Sintea Plastek, LLC devices

FDA 510(k) Submission Details - K112611

510(k) Number K112611 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 2011
Decision Date April 25, 2012
Days to Decision 231 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
109d slower than avg
Panel avg: 122d · This submission: 231d
Pathway characteristics
Modification to existing cleared device.

MNI Device Classification - Class 2, Special Controls

Product Code MNI Orthosis, Spinal Pedicle Fixation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3070
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 - MNI Orthosis, Spinal Pedicle Fixation

All 199
Devices cleared under the same product code (MNI) and FDA review panel - the closest regulatory comparables to K112611.
RANGE SPINAL SYSTEM, UNIT ROD
K120899 · K2m, Inc. · May 2012
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K120879 · L & K Biomed Co., Ltd. · May 2012
RANGE SPINAL SYSTEM (MESA AND DENALI)
K120099 · K2m, Inc. · May 2012
EVEREST SPINAL SYSTEM
K120656 · K2m, Inc. · Apr 2012
TIGER SPINE SYSTEM
K120696 · Corelink, LLC · Apr 2012
AILERON INTERSPINOUS FIXATION SYSTEM
K113157 · Life Spine · Mar 2012