Cleared Special

K111115 - CAPTIVA SPINE CAPLOX II SPINAL FIXATION...

K111115 is the FDA 510(k) clearance for CAPTIVA SPINE CAPLOX II SPINAL FIXATION... by Captiva Spine, Inc.. It is a Class 2 Orthopedic device (product code MNI) cleared through the Special 510(k) pathway after a 145-day FDA review.

K111115 · Captiva Spine, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2011
Decision
145d
Days
Class 2
Risk

K111115 is an FDA 510(k) clearance for the CAPTIVA SPINE CAPLOX II SPINAL FIXATION SYSTEM. Classified as Orthosis, Spinal Pedicle Fixation (product code MNI), Class II - Special Controls.

Submitted by Captiva Spine, Inc. (Sunrise, US). The FDA issued a Cleared decision on September 13, 2011 after a review of 145 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 Captiva Spine, Inc. devices

Submission Details

510(k) Number K111115 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 21, 2011
Decision Date September 13, 2011
Days to Decision 145 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
23d slower than avg
Panel avg: 122d · This submission: 145d
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 119
Devices cleared under the same product code (MNI) and FDA review panel - the closest regulatory comparables to K111115.
EVEREST SPINAL SYSTEM
K120656 · K2m, Inc. · Apr 2012
RANGE SPINAL SYSTEM (MESA AND DENALI)
K112920 · K2m, Inc. · Dec 2011
RANGE SPINAL SYSTEM (MESA AND DENALI)
K112037 · K2m, Inc. · Oct 2011
CAPSURE(R) PS SYSTEM
K111913 · Spine Wave, Inc. · Aug 2011
ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM
K112108 · Spineart · Aug 2011
ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM
K111127 · Spineart · Aug 2011