Cleared Special

K100191 - LANX POSTERIOR CERVICOTHORACIC SPINAL F...

K100191 is an FDA 510(k) clearance for LANX POSTERIOR CERVICOTHORACIC SPINAL F..., manufactured by Lanx, Inc.. The device is a Class 2 Orthopedic device with product code KWP cleared through the Special 510(k) pathway after a 83-day FDA review.

K100191 · Lanx, Inc. · Orthopedic device
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Apr 2010
Decision
83d
Days
Class 2
Risk

K100191 is an FDA 510(k) clearance for the LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM (PCFS). Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by Lanx, Inc. (Broomfield, US). The FDA issued a Cleared decision on April 15, 2010 after a review of 83 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3050 - 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. Low regulatory complexity profile. 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 - K100191

510(k) Number K100191 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 2010
Decision Date April 15, 2010
Days to Decision 83 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
39d faster than avg
Panel avg: 122d · This submission: 83d
Pathway characteristics
Modification to existing cleared device.

KWP Device Classification - Class 2, Special Controls

Product Code KWP Appliance, Fixation, Spinal Interlaminal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3050
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 - KWP Appliance, Fixation, Spinal Interlaminal

All 309
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K100191.
PRIMAL OK INTERSPINOUS FUSION SYSTEM
K100354 · Osteomed LP · Aug 2010
NUVASIVE VUEPOINT OCT SYSTEM
K093319 · Nuvasive, Inc. · Jun 2010
ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM
K100685 · Alphatec Spine, Inc. · Jun 2010
PIONEER POSTERIOR CERVICO-THORACIC SYSTEM
K092295 · Pioneer Surgical Technology · Feb 2010
MODIFICATION TO CASPIAN SPINAL SYSTEM
K093534 · K2m, Inc. · Dec 2009
LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM
K092656 · Lanx, Inc. · Nov 2009