Cleared Traditional

K181799 - ResCUBE™ Ligament Fixation System (FDA 510(k) Clearance)

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

K181799 · Cousin Biotech Sas · Orthopedic device
Aug 2018
Decision
55d
Days
Class 2
Risk

K181799 is an FDA 510(k) clearance for the ResCUBE™ Ligament Fixation System. Classified as Bone Fixation Cerclage, Sublaminar (product code OWI), Class II - Special Controls.

Submitted by Cousin Biotech Sas (Wervicq-Sud, FR). The FDA issued a Cleared decision on August 29, 2018 after a review of 55 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

Submission Details

510(k) Number K181799 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 2018
Decision Date August 29, 2018
Days to Decision 55 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 116d · This submission: 55d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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

Devices cleared under the same product code (OWI) and FDA review panel - the closest regulatory comparables to K181799.
Invictus Bands System
K253615 · Alphatec Spine, Inc. · Mar 2026
OLYMPIC Deformity Band System
K222097 · Astura Medical · May 2023
HILINE™ Fixation System
K230565 · Globus Medical, Inc. · Apr 2023
LigaPASS™ 2.0 Ligament Augmentation System
K213659 · Medicrea International SA · May 2022
LigaPASS® Spinal System, CD Horizon™ Spinal System
K211057 · Medtronic, Inc. · May 2021