Cleared Special

K111115 - CAPTIVA SPINE CAPLOX II SPINAL FIXATION SYSTEM

K111115 is an FDA 510(k) clearance for CAPTIVA SPINE CAPLOX II SPINAL FIXATION..., manufactured by Captiva Spine, Inc.. The device is a Class 2 Orthopedic device with 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) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K111115

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
23d slower than avg
Panel avg: 122d · This submission: 145d
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 K111115.
PASS LP SPINAL SYSTEM
K112493 · Medicrea International · Nov 2011
SMARTLOC SPINAL FIXATION SYSTEM
K111883 · A-Spine Asia, Co., Ltd. · Oct 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
K111115 · CAPTIVA SPINE CAPLOX II SPINAL FIXATION SYSTEM
Download PDF FDA Summary Captiva Spine, Inc.