Cleared Special

K122332 - TOWERLOX PEDICLE SCREW SYSTEM

K122332 is an FDA 510(k) clearance for TOWERLOX PEDICLE SCREW SYSTEM, manufactured by Captiva Spine. The device is a Class 2 Orthopedic device with product code MNI cleared through the Special 510(k) pathway after a 75-day FDA review.

K122332 · Captiva Spine · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2012
Decision
75d
Days
Class 2
Risk

K122332 is an FDA 510(k) clearance for the TOWERLOX PEDICLE SCREW SYSTEM. Classified as Orthosis, Spinal Pedicle Fixation (product code MNI), Class II - Special Controls.

Submitted by Captiva Spine (Apple Valley, US). The FDA issued a Cleared decision on October 16, 2012 after a review of 75 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.

View all Captiva Spine devices

FDA 510(k) Submission Details - K122332

510(k) Number K122332 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 2012
Decision Date October 16, 2012
Days to Decision 75 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 122d · This submission: 75d
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 194
Devices cleared under the same product code (MNI) and FDA review panel - the closest regulatory comparables to K122332.
RELIANCE SPINAL SCREW SYSTEM
K123521 · Reliance Medical Systems, LLC · Feb 2013
S-LOK PSS SYSTEM
K122931 · Spinal USA · Nov 2012
CERTEX SPINAL IMPLANT SYSTEM
K122163 · X-Spine Systems, Inc. · Oct 2012
CAPSURE(R) PS SYSTEM
K122233 · Spine Wave, Inc. · Oct 2012
REFORM PEDICLE SCREW SYSTEM
K121172 · Spinal USA · Aug 2012
CAPSURE(R) PS SYSTEM
K120646 · Spine Wave, Inc. · Jun 2012