Cleared Special

K160020 - Captiva Spine and CapLOX II/TowerLOX Pedicle Screw System

K160020 is an FDA 510(k) clearance for Captiva Spine and CapLOX II/TowerLOX Pe..., manufactured by Captiva Spine. The device is a Class 2 Orthopedic device with product code MNH cleared through the Special 510(k) pathway after a 57-day FDA review.

K160020 · Captiva Spine · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2016
Decision
57d
Days
Class 2
Risk

K160020 is an FDA 510(k) clearance for the Captiva Spine and CapLOX II/TowerLOX Pedicle Screw System. Classified as Orthosis, Spondylolisthesis Spinal Fixation (product code MNH), Class II - Special Controls.

Submitted by Captiva Spine (Jupiter, US). The FDA issued a Cleared decision on March 2, 2016 after a review of 57 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 - K160020

510(k) Number K160020 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 05, 2016
Decision Date March 02, 2016
Days to Decision 57 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
65d faster than avg
Panel avg: 122d · This submission: 57d
Pathway characteristics
Modification to existing cleared device.

MNH Device Classification - Class 2, Special Controls

Product Code MNH Orthosis, Spondylolisthesis Spinal 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 Consultant

Empirical Testing Corp
Kennneth C. Maxwell

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - MNH Orthosis, Spondylolisthesis Spinal Fixation

All 303
Devices cleared under the same product code (MNH) and FDA review panel - the closest regulatory comparables to K160020.
ANAX™ 5.5 Spinal System
K162189 · U&I Corporation · Aug 2016
HC Spinal System
K151362 · Hung Chun Bio-S Co., Ltd. · May 2016
Zavation Spinal System
K153404 · Zavation, LLC · Apr 2016
Spinal Inner Fixation System
K143013 · Changzhou Dingjian Medical Appliance Co., Ltd. · Dec 2015
Romeo posterior osteosynthesis system
K151695 · Spineart · Sep 2015
CapLOX II/TowerLOX Pedicle Screw System
K151116 · Captiva Spine · Jun 2015