Cleared Special

K103671 - GENESYS SPINE TILOCK SYSTEM

K103671 is an FDA 510(k) clearance for GENESYS SPINE TILOCK SYSTEM, manufactured by Genesys Spine. The device is a Class 2 Orthopedic device with product code NKB cleared through the Special 510(k) pathway after a 217-day FDA review.

K103671 · Genesys Spine · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2011
Decision
217d
Days
Class 2
Risk

K103671 is an FDA 510(k) clearance for the GENESYS SPINE TILOCK SYSTEM. Classified as Thoracolumbosacral Pedicle Screw System within the NKB classification (a category for thoracolumbosacral pedicle screw systems), Class II - Special Controls.

Submitted by Genesys Spine (Austin, US). The FDA issued a Cleared decision on July 21, 2011 after a review of 217 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 Genesys Spine devices

FDA 510(k) Submission Details - K103671

510(k) Number K103671 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 2010
Decision Date July 21, 2011
Days to Decision 217 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
95d slower than avg
Panel avg: 122d · This submission: 217d
Pathway characteristics
Modification to existing cleared device.

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 875
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K103671.
STRYKER SPINE POWER ADAPTOR (ACCESSORY INSTRUMENT)
K111478 · Stryker Corporation · Aug 2011
DEL MAR MONOAXIAL PEDICLE SCREW SYSTEM
K110679 · Phygen, LLC · Aug 2011
APEX SPINE SYSTEM
K110906 · Spinecraft, LLC · Jul 2011
ATLAS SPINE PEDICLE SCREW SYSTEM
K110842 · Atlas Spine, Inc. · Jul 2011
SOLANAS AVALON POSTERIOR FIXATION SYSTEM
K111076 · Alphatec Spine, Inc. · Jul 2011
REVLOK FENESTRATED SCREW SYSTEM
K110280 · Globus Medical, Inc. · Jul 2011