Cleared Special

K120292 - CAPLOX II PEDICLE SCREW SYSTEM

K120292 is an FDA 510(k) clearance for CAPLOX II PEDICLE SCREW SYSTEM, 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 73-day FDA review.

K120292 · Captiva Spine, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2012
Decision
73d
Days
Class 2
Risk

K120292 is an FDA 510(k) clearance for the CAPLOX II PEDICLE SCREW SYSTEM. Classified as Orthosis, Spinal Pedicle Fixation (product code MNI), Class II - Special Controls.

Submitted by Captiva Spine, Inc. (Apple Valley, US). The FDA issued a Cleared decision on April 13, 2012 after a review of 73 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 - K120292

510(k) Number K120292 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 2012
Decision Date April 13, 2012
Days to Decision 73 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
49d faster than avg
Panel avg: 122d · This submission: 73d
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 K120292.
LEXUS CERVICAL FIXATION SYSTEM
K120879 · L & K Biomed Co., Ltd. · May 2012
RANGE SPINAL SYSTEM (MESA AND DENALI)
K120099 · K2m, Inc. · May 2012
SINTEA PLUSTEK PLS MULTI-AXIAL SCREWS
K112611 · Sintea Plastek, LLC · Apr 2012
EVEREST SPINAL SYSTEM
K120656 · K2m, Inc. · Apr 2012
TIGER SPINE SYSTEM
K120696 · Corelink, LLC · Apr 2012
PALLS M SPINAL SYSTEM
K120538 · Korea Bone Bank Co., Ltd. · Mar 2012
K120292 · CAPLOX II PEDICLE SCREW SYSTEM
Download PDF FDA Summary Captiva Spine, Inc.