Cleared Traditional

K180728 - Spinal Elements Cerclage System

K180728 is an FDA 510(k) clearance for Spinal Elements Cerclage System, manufactured by Spinal Elements, Inc.. The device is a Class 2 Orthopedic device with product code OWI cleared through the Traditional 510(k) pathway after a 170-day FDA review.

K180728 · Spinal Elements, Inc. · Orthopedic device
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Sep 2018
Decision
170d
Days
Class 2
Risk

K180728 is an FDA 510(k) clearance for the Spinal Elements Cerclage System. Classified as Bone Fixation Cerclage, Sublaminar (product code OWI), Class II - Special Controls.

Submitted by Spinal Elements, Inc. (Carlsbad, US). The FDA issued a Cleared decision on September 6, 2018 after a review of 170 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 Spinal Elements, Inc. devices

FDA 510(k) Submission Details - K180728

510(k) Number K180728 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 2018
Decision Date September 06, 2018
Days to Decision 170 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
48d slower than avg
Panel avg: 122d · This submission: 170d
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 K180728.
JAZZ PF
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ResCUBE™ Ligament Fixation System
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NAJA™ Ligament Correction System
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LigaPASS
K173506 · Medicrea International SA · Apr 2018