Cleared Special

K100935 - LANX SPINAL FIXATION SYSTEM

K100935 is an FDA 510(k) clearance for LANX SPINAL FIXATION SYSTEM, manufactured by Lanx, Inc.. The device is a Class 2 Orthopedic device with product code NKB cleared through the Special 510(k) pathway after a 123-day FDA review.

K100935 · Lanx, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2010
Decision
123d
Days
Class 2
Risk

K100935 is an FDA 510(k) clearance for the LANX 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 Lanx, Inc. (Broomfield, US). The FDA issued a Cleared decision on August 6, 2010 after a review of 123 days - within the typical 510(k) review window.

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 Lanx, Inc. devices

FDA 510(k) Submission Details - K100935

510(k) Number K100935 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 2010
Decision Date August 06, 2010
Days to Decision 123 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
1d slower than avg
Panel avg: 122d · This submission: 123d
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 706
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K100935.
MANTIS SPINAL SYSTEM & MANTIS REDUX SPINAL SYSTEM
K102235 · Stryker Spine · Aug 2010
STAINLESS STEEL SPINAL SYSTEM
K100970 · Theken Spine, LLC · Aug 2010
QUANTUM/ STREAMLINE SPINAL SYSTEM MODEL 02-SERIES AND 10-SERIES
K093692 · Pioneer Surgical Technology · Aug 2010
MODIFICATION TO SYNTHES MATRIX SYSTEM
K100952 · Synthes Spine · Aug 2010
FIREBIRD SPINAL FIXATION SYSTEM
K093926 · Blackstone Medical, Inc. · Jul 2010
MODIFICATION TO:RADIUS SPINAL SYSTEM
K101144 · Stryker Spine · Jul 2010