Cleared Traditional

K092656 - LANX POSTERIOR CERVICOTHORACIC SPINAL F...

K092656 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 Traditional 510(k) pathway after a 88-day FDA review.

K092656 · Lanx, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2009
Decision
88d
Days
Class 2
Risk

K092656 is an FDA 510(k) clearance for the LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM. 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 November 24, 2009 after a review of 88 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Lanx, Inc. devices

FDA 510(k) Submission Details - K092656

510(k) Number K092656 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 2009
Decision Date November 24, 2009
Days to Decision 88 days
Submission Type Traditional
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
34d faster than avg
Panel avg: 122d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K092656.
LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM (PCFS)
K100191 · Lanx, Inc. · Apr 2010
PIONEER POSTERIOR CERVICO-THORACIC SYSTEM
K092295 · Pioneer Surgical Technology · Feb 2010
MODIFICATION TO CASPIAN SPINAL SYSTEM
K093534 · K2m, Inc. · Dec 2009
SENTINEL SPINAL SYSTEM
K090343 · Life Spine · Aug 2009
SYNAPSE SYSTEM 4.0MM, OC FUSION SYSTEM 4.0MM
K091689 · Synthes (Usa) · Jul 2009
ELLIPSE OCCIPITO-CERICO-THORACIC SPINAL SYSTEM
K090565 · Globus Medical, Inc. · Jun 2009