Cleared Traditional

STGC-LORDOTIC (K142030) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K142030 · Cardinal Spine, LLC · Orthopedic device
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Jan 2015
Decision
182d
Days
Class 2
Risk

K142030 is an FDA 510(k) clearance for the STGC-LORDOTIC. Classified as Spinal Vertebral Body Replacement Device (product code MQP), Class II - Special Controls.

Submitted by Cardinal Spine, LLC (San Diego, US). The FDA issued a Cleared decision on January 23, 2015 after a review of 182 days - an extended review cycle.

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

View all Cardinal Spine, LLC devices

Submission Details

510(k) Number K142030 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 2014
Decision Date January 23, 2015
Days to Decision 182 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
60d slower than avg
Panel avg: 122d · This submission: 182d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MQP Spinal Vertebral Body Replacement Device
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 Peers - MQP Spinal Vertebral Body Replacement Device

All 36
Devices cleared under the same product code (MQP) and FDA review panel - the closest regulatory comparables to K142030.
T2 STRATOSPHERE™ Expandable Corpectomy System
K173125 · Medtronic Sofamor Danek · Dec 2017
FORTIFY Corpectomy Spacers
K162315 · Globus Medical, Inc. · Nov 2017
NuVasive(r) Monolith Corpectomy System
K170271 · Nu Vasive, Incorporated · Mar 2017
FORTIFY INTEGRATED CORPECTOMY SPACERS, (FORTIFY I AND FORTIFY I-R)
K121107 · Globus Medical, Inc. · Jul 2012
FORTIFY(TM) AND FORTIFY(TM)-R CORPECTOMY SPACERS
K112756 · Globus Medical, Inc. · Oct 2011
AESCULAP PEEK VERTEBRAL BODY REPLACEMENT SYSTEM
K060762 · Aesculap, Inc. · Sep 2006