Cleared Traditional

K133482 - SILC FIXATION SYSTEM

K133482 is an FDA 510(k) clearance for SILC FIXATION SYSTEM, manufactured by Globus Medical, Inc.. The device is a Class 2 Orthopedic device with product code OWI cleared through the Traditional 510(k) pathway after a 189-day FDA review.

K133482 · Globus Medical, Inc. · Orthopedic device
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May 2014
Decision
189d
Days
Class 2
Risk

K133482 is an FDA 510(k) clearance for the SILC FIXATION SYSTEM. Classified as Bone Fixation Cerclage, Sublaminar (product code OWI), Class II - Special Controls.

Submitted by Globus Medical, Inc. (Audubon, US). The FDA issued a Cleared decision on May 21, 2014 after a review of 189 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3010 - 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 - K133482

510(k) Number K133482 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 2013
Decision Date May 21, 2014
Days to Decision 189 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
67d slower than avg
Panel avg: 122d · This submission: 189d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OWI Device Classification - Class 2, Special Controls

Product Code OWI Bone Fixation Cerclage, Sublaminar
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3010
Definition Acts As A Bone Anchor For Temporary Stabilization, Or Used In Conjunction With Other Medical Implants Of Similar Metals When Wiring Is Needed, During Development Of A Spinal Fusion.
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 - OWI Bone Fixation Cerclage, Sublaminar

All 36
Devices cleared under the same product code (OWI) and FDA review panel - the closest regulatory comparables to K133482.
JAZZ System
K143759 · Implanet, S.A. · May 2015
Nile Alternative Fixation
K143350 · K2m, Inc. · Feb 2015
UNIVERSAL CLAMP SPINAL FIXATION SYSTEM
K142053 · Zimmer Spine, Inc. · Oct 2014
JAZZ SYSTEM
K133617 · Implanet, S.A. · Feb 2014
LIGAPASS
K132395 · Medicrea International · Dec 2013
JAZZ SYSTEM
K132287 · Hogan Lovells US LLP · Sep 2013