Cleared Special

K093285 - MODIFICATION TO LANX SPINAL FIXATION SYSTEM

K093285 is an FDA 510(k) clearance for MODIFICATION TO LANX SPINAL FIXATION SYSTEM, manufactured by Lanx, LLC. The device is a Class 2 Orthopedic device with product code MNI cleared through the Special 510(k) pathway after a 51-day FDA review.

K093285 · Lanx, LLC · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2009
Decision
51d
Days
Class 2
Risk

K093285 is an FDA 510(k) clearance for the MODIFICATION TO LANX SPINAL FIXATION SYSTEM. Classified as Orthosis, Spinal Pedicle Fixation (product code MNI), Class II - Special Controls.

Submitted by Lanx, LLC (Broomfield, US). The FDA issued a Cleared decision on December 10, 2009 after a review of 51 days - a notably fast clearance 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. 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.

FDA 510(k) Submission Details - K093285

510(k) Number K093285 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 2009
Decision Date December 10, 2009
Days to Decision 51 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
71d faster than avg
Panel avg: 122d · This submission: 51d
Pathway characteristics
Modification to existing cleared device.

MNI Device Classification - Class 2, Special Controls

Product Code MNI Orthosis, Spinal Pedicle Fixation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3070
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 - MNI Orthosis, Spinal Pedicle Fixation

All 302
Devices cleared under the same product code (MNI) and FDA review panel - the closest regulatory comparables to K093285.
PASS LP SPINAL SYSTEM
K100297 · Medicrea Technologies · Mar 2010
ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM
K100138 · Alphatec Spine, Inc. · Feb 2010
ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM
K093077 · Alphatec Spine, Inc. · Dec 2009
KRD1 PEDICLE SCREW SYSTEM
K092420 · Spinefrontier, Inc. · Nov 2009
CASPIAN SPINAL SYSTEM
K092640 · K2m, Inc. · Nov 2009
ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM
K093170 · Spineart · Nov 2009
K093285 · MODIFICATION TO LANX SPINAL FIXATION SYSTEM
Download PDF FDA Summary Lanx, LLC