Cleared Traditional

K124058 - CREO STABILIZATION SYSTEM

K124058 is an FDA 510(k) clearance for CREO STABILIZATION SYSTEM, manufactured by Globus Medical, Inc.. The device is a Class 2 Orthopedic device with product code OSH cleared through the Traditional 510(k) pathway after a 133-day FDA review.

K124058 · Globus Medical, Inc. · Orthopedic device
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May 2013
Decision
133d
Days
Class 2
Risk

K124058 is an FDA 510(k) clearance for the CREO STABILIZATION SYSTEM. Classified as Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis (product code OSH), Class II - Special Controls.

Submitted by Globus Medical, Inc. (Audubon, US). The FDA issued a Cleared decision on May 13, 2013 after a review of 133 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. 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 Globus Medical, Inc. devices

FDA 510(k) Submission Details - K124058

510(k) Number K124058 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 31, 2012
Decision Date May 13, 2013
Days to Decision 133 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
11d slower than avg
Panel avg: 122d · This submission: 133d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OSH Device Classification - Class 2, Special Controls

Product Code OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3070
Definition Intended To Stabilize The Thoracolumbar Spine As An Adjunct To Fusion Using Allograft And/or Autograft To Treat Adolescent Idiopathic Scoliosis.
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 - OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis

All 18
Devices cleared under the same product code (OSH) and FDA review panel - the closest regulatory comparables to K124058.
POLARIS SPINAL SYSTEM
K131615 · Biomet Spine (Aka Ebi, LLC) · Sep 2013
RANGE SPINAL SYSTEM
K131784 · K2m, Inc. · Aug 2013
CD HORIZON SPINAL SYSTEM
K131321 · Medtronic Sofamor Danek USA · Jun 2013
RANGE SPINAL SYSTEM
K131030 · K2m, Inc. · May 2013
RANGE SPINAL SYSTEM, SMALL STATURE
K122877 · K2m, Inc. · May 2013
RESPONSE SPINE SYSTEM
K130655 · OrthoPediatrics Corp. · May 2013