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) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

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
Combination Product No
PCCP Authorized No
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 302
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
LEXUS CERVICAL FIXATION SYSTEM
K120879 · L & K Biomed Co., Ltd. · May 2012
RANGE SPINAL SYSTEM (MESA AND DENALI)
K120099 · K2m, Inc. · May 2012
CAPLOX II PEDICLE SCREW SYSTEM
K120292 · Captiva Spine, Inc. · Apr 2012
EVEREST SPINAL SYSTEM
K120656 · K2m, Inc. · Apr 2012
TIGER SPINE SYSTEM
K120696 · Corelink, LLC · Apr 2012
K112611 · SINTEA PLUSTEK PLS MULTI-AXIAL SCREWS
Download PDF FDA Summary Sintea Plastek, LLC