Cleared Traditional

K101971 - SYNTEC OS SPINAL FIXATION SYSTEM

K101971 is an FDA 510(k) clearance for SYNTEC OS SPINAL FIXATION SYSTEM, manufactured by Syntec Scientific Corp.. The device is a Class 2 Orthopedic device with product code NKB cleared through the Traditional 510(k) pathway after a 255-day FDA review.

K101971 · Syntec Scientific Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2011
Decision
255d
Days
Class 2
Risk

K101971 is an FDA 510(k) clearance for the SYNTEC OS SPINAL FIXATION SYSTEM. Classified as Thoracolumbosacral Pedicle Screw System within the NKB classification (a category for thoracolumbosacral pedicle screw systems), Class II - Special Controls.

Submitted by Syntec Scientific Corp. (Chang Hua, TW). The FDA issued a Cleared decision on March 25, 2011 after a review of 255 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Syntec Scientific Corp. devices

FDA 510(k) Submission Details - K101971

510(k) Number K101971 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 13, 2010
Decision Date March 25, 2011
Days to Decision 255 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
133d slower than avg
Panel avg: 122d · This submission: 255d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NKB Device Classification - Class 2, Special Controls

Product Code NKB Thoracolumbosacral Pedicle Screw System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3070
Definition Intended To Provide Immobilization And Stabilization Of Spinal Segments In Thoracic, Lumbar, And Sacral Spine As An Adjunct To Fusion.
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 - NKB Thoracolumbosacral Pedicle Screw System

All 733
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K101971.
TSRH SPINAL SYSTEM
K110676 · Medtronic Sofamor Danek · May 2011
STREAMLINE TL SPINAL SYSTEM
K110692 · Pioneer Surgical Technology, Inc. · May 2011
EXPEDIUM SYSTEM, VIPER SYSTEM
K110216 · Depuy Spine, Inc. · Apr 2011
LANX SPINAL SYSTEM
K103237 · Lanx, Inc. · Mar 2011
REVERE SACRAL PLATES
K103072 · Globus Medical, Inc. · Mar 2011
QUANTUM SPINAL SYSTEM, QUANTUM MIS
K101790 · Pioneer Surgical Technology · Mar 2011