Cleared Traditional

LigaPASS? 2.0 Ligament Augmentation System

K213659 · Medicrea International SA · Orthopedic

May 2022

Decision

186d

Days

Class 2

Risk

About This 510(k) Submission

K213659 is an FDA 510(k) clearance for the LigaPASS? 2.0 Ligament Augmentation System, a Bone Fixation Cerclage, Sublaminar (Class II — Special Controls, product code OWI), submitted by Medicrea International SA (Rillieux-La-Pape, FR). The FDA issued a Cleared decision on May 24, 2022, 186 days after receiving the submission on November 19, 2021. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3010.

Submission Details

510(k) Number	K213659 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 19, 2021
Decision Date	May 24, 2022
Days to Decision	186 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	OWI — Bone Fixation Cerclage, Sublaminar
Device Class	Class II — 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.