Cleared Special

K113157 - AILERON INTERSPINOUS FIXATION SYSTEM

K113157 is the FDA 510(k) clearance for AILERON INTERSPINOUS FIXATION SYSTEM by Life Spine. It is a Class 2 Orthopedic device (product code MNI) cleared through the Special 510(k) pathway after a 139-day FDA review.

K113157 · Life Spine · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2012
Decision
139d
Days
Class 2
Risk

K113157 is an FDA 510(k) clearance for the AILERON INTERSPINOUS FIXATION SYSTEM. Classified as Orthosis, Spinal Pedicle Fixation (product code MNI), Class II - Special Controls.

Submitted by Life Spine (Hoffman Est, US). The FDA issued a Cleared decision on March 13, 2012 after a review of 139 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 Life Spine devices

Submission Details

510(k) Number K113157 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 26, 2011
Decision Date March 13, 2012
Days to Decision 139 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
17d slower than avg
Panel avg: 122d · This submission: 139d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 145
Devices cleared under the same product code (MNI) and FDA review panel - the closest regulatory comparables to K113157.
RANGE SPINAL SYSTEM (MESA AND DENALI)
K120099 · K2m, Inc. · May 2012
EVEREST SPINAL SYSTEM
K120656 · K2m, Inc. · Apr 2012
TIGER SPINE SYSTEM
K120696 · Corelink, LLC · Apr 2012
SYNTHES USS CONNECTORS
K113149 · Synthes Spine · Feb 2012
RANGE SPINAL SYSTEM (MESA AND DENALI)
K112920 · K2m, Inc. · Dec 2011
RANGE SPINAL SYSTEM (MESA AND DENALI)
K112037 · K2m, Inc. · Oct 2011