Cleared Special

K132365 - SPONDYLOLISTHESIS SPINAL FIXATION, SPINAL PEDICLE FIXATION

K132365 is an FDA 510(k) clearance for SPONDYLOLISTHESIS SPINAL FIXATION, manufactured by Accel Spine. The device is a Class 2 Orthopedic device with product code MNI cleared through the Special 510(k) pathway after a 21-day FDA review.

K132365 · Accel Spine · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2013
Decision
21d
Days
Class 2
Risk

K132365 is an FDA 510(k) clearance for the SPONDYLOLISTHESIS SPINAL FIXATION, SPINAL PEDICLE FIXATION. Classified as Orthosis, Spinal Pedicle Fixation (product code MNI), Class II - Special Controls.

Submitted by Accel Spine (Dallas, US). The FDA issued a Cleared decision on August 20, 2013 after a review of 21 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 - K132365

510(k) Number K132365 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 2013
Decision Date August 20, 2013
Days to Decision 21 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
101d faster than avg
Panel avg: 122d · This submission: 21d
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 K132365.
INERTIA MIS PEDICLE SCREW SYSTEM
K132412 · Nexxt Spine, LLC · Oct 2013
EVEREST SPINAL SYSTEM
K132361 · K2m, Inc. · Oct 2013
LOSPA IS PEDICLE SCREW (MONOAXIAL & POLYAXIAL), LOSPA IS ROD- STRAIGHT (STANDARD), LOSPA IS ROD- PRE BENT (STANDARD & BU
K132644 · Corentec Co., Ltd. · Sep 2013
CORE PEDICLE SCREW SYSTEM
K131522 · Core-Nexus · Aug 2013
CAPSURE PS SYSTEM
K132154 · Spine Wave, Inc. · Aug 2013
SPINEVISION LUMIS CANNULATED POLYAXIAL PEDICLE SCREW FIXATION SYSTEM, SPINEVISION U.L.I.S. POLYAXIAL PEDICLE SCREW FIXAT
K130302 · Spinevision S.A. · Jul 2013