Cleared Traditional

ResCUBE™ Ligament Fixation System (K181799) - 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
Download Printable Device Report (PDF)
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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.

View all Cousin Biotech Sas devices

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
67d faster than avg
Panel avg: 122d · 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

All 36
Devices cleared under the same product code (OWI) and FDA review panel - the closest regulatory comparables to K181799.
LigaPASS™ System
K261374 · Medicrea International S.A.S · May 2026
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