Bone Fixation Cerclage, Sublaminar
Orthopedic · 21 CFR 888.3010
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.
Recent MDR events
68 adverse event reports on file
- LIGAPASSJun 18, 2026MalfunctionMedicrea International Sa1000432246-2026-00024
- LIGAPASSJun 18, 2026MalfunctionMedicrea International Sa1000432246-2026-00025
- LIGAPASSJun 18, 2026MalfunctionMedicrea International Sa1000432246-2026-00026
- UNKNOWNApr 24, 2026InjuryMedtronic Sofamor Danek Usa, Inc.3003120897-2026-00768
- JAZZ LOCKFeb 16, 2026MalfunctionImplanet3007675554-2025-00001
- JAZZ LOCKFeb 16, 2026MalfunctionImplanet3007675554-2025-00002
- JAZZ LOCKFeb 16, 2026MalfunctionImplanet3007675554-2025-00003
- LIGAPASS 2.0Sep 23, 2025MalfunctionMedicrea International Sa1000432246-2025-00023
- LIGAPASS 2.0Sep 23, 2025MalfunctionMedicrea International Sa1000432246-2025-00024
- LIGA PASSJul 15, 2025MalfunctionMedicrea International Sa1000432246-2025-00019
Event type breakdown
Recalls
2 recall events for this product code
- Medicrea InternationalTerminatedUnknown
MEDICREA LIGAPASS TENSION PULLEY HANDLE XS-
Tightening the LIGAPASS Band with this instrument, the tensioner's pliers can crush the band causing the band to break during surgery and lead to a risk of infection and re-intervention ,
Z-0463-2021 · View FDA record ↗ - OrthoPediatrics CorpTerminatedUnknown
Response BandLoc 5.5/6.0 Tensioner Instrument
Over-tensioning of the band resulting in damage to the band causing it to rupture
Z-2321-2017 · View FDA record ↗
Registered firms
133 firms currently registered for this product code
Medtronic Engineering And Innovation Center (meic)
Hyderabad Telangana, IN
Olive Branch Distribution Center
Olive Branch, MS, US
Nginstruments, Inc Dba Avalign Cutting Instruments
Warsaw, IN, US
Arch Medical Solutions - Olive Branch
Olive Branch, MS, US
First Article Inc
Souderton, PA, US
Implanet
Martillac Nouvelle-Aquitaine, FR
Globus Medical, Inc.
AUDUBON, PA, US
Ferry Machine Corporation
Oakland, NJ, US
Flex-cell Precision, Inc.
Lancaster, PA, US
Sanavita Medical, Llc
Telford, PA, US
Cefimeca
La Talaudiere Loire, FR
Alphatec Spine, Inc.
Carlsbad, CA, US
K2m, Inc.
Leesburg, VA, US
Simon Sas
Bayeux Calvados, FR
Bradshaw Medical Inc.
Kenosha, WI, US
Arch Medical Solutions - Philadelphia, Llc Dba Jade Precision Medical Components
Huntingdon Valley, PA, US
Simagec
ROUSSET CEDEX Bouches-du-Rhone, FR
Isomedix Operations Inc.
Sandy, UT, US
Astura Medical
Irving, TX, US
Medtronic Sofamor Danek Usa, Inc.
Memphis, TN, US
510(k) clearances
37 clearances for this product code
- Medicrea International S.A.SMay 27, 2026
K261374 · LigaPASS System
- Alphatec Spine, Inc.Mar 25, 2026
K253615 · Invictus Bands System
- Astura MedicalMay 4, 2023
K222097 · OLYMPIC Deformity Band System
- Globus Medical, Inc.Apr 20, 2023
K230565 · HILINE Fixation System
- Medicrea International SAMay 24, 2022
K213659 · LigaPASS 2.0 Ligament Augmentation System
- Medtronic, Inc.May 27, 2021
K211057 · LigaPASS® Spinal System, CD Horizon Spinal System
- SeaSpine Orthopedics CorporationAug 5, 2020
K201240 · Mariner Cap System
- Ortho Development CorporationMar 31, 2020
K200281 · The Gecko Spinal System