Cleared Traditional

K141332 - Captiva Spine SmartLOX Cervical Plate System

K141332 is an FDA 510(k) clearance for Captiva Spine SmartLOX Cervical Plate S..., manufactured by Captiva Spine. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Traditional 510(k) pathway after a 386-day FDA review.

K141332 · Captiva Spine · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2015
Decision
386d
Days
Class 2
Risk

K141332 is an FDA 510(k) clearance for the Captiva Spine SmartLOX Cervical Plate System. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Captiva Spine (Jupiter, US). The FDA issued a Cleared decision on June 11, 2015 after a review of 386 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3060 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K141332

510(k) Number K141332 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 2014
Decision Date June 11, 2015
Days to Decision 386 days
Submission Type Traditional
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
264d slower than avg
Panel avg: 122d · This submission: 386d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KWQ Device Classification - Class 2, Special Controls

Product Code KWQ Appliance, Fixation, Spinal Intervertebral Body
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3060
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

Silver Spine Consulting
Richard Jansen

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 - KWQ Appliance, Fixation, Spinal Intervertebral Body

All 657
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K141332.
CastleLoc-P Anterior Cervical Plate System
K143271 · L & K Biomed Co., Ltd. · Jul 2015
ASFORA ANTERIOR CERVICAL PLATE SYSTEM
K143688 · Medical Designs, LLC · Jul 2015
uNion Cervical Plate System
K150666 · Ulrich Medical USA · Jun 2015
Azure Anterior Cervical Plate System
K143028 · Orthofix, Inc. · May 2015
Blue Mountain Cervical Plate System
K150036 · Spineway · May 2015
Pyrenees Cervical Plate System
K142212 · K2m, Inc. · May 2015