Bone Fixation Cerclage, Sublaminar
FDA product code OWI · Class II (moderate risk) · 21 CFR 888.3010 · Orthopedic
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.
37510(k) clearances
0PMA approvals
2recalls
Implantimplanted device
Manufacturers
- Implanet, S.A. 7
- Medicrea International 5
- Globus Medical, Inc. 3
- K2m, Inc. 3
- Nu Vasive, Incorporated 2
- OrthoPediatrics Corp. 2
- Zimmer Spine, Inc. 2
- Cousin Biotech Sas 2
- Spinal Elements, Inc. 2
- Nuvasive, Inc. 1
- Medicrea International S.A.S 1
- Alphatec Spine, Inc. 1
- Astura Medical 1
- Medtronic, Inc. 1
- SeaSpine Orthopedics Corporation 1
- Ortho Development Corp. 1
- Medtronic Sofamor Danek USA, Inc. 1
- Hogan Lovells US LLP 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261374 | LigaPASS SystemOWI · Special | Medicrea International S.A.S | 05/27/2026SE |
| K253615 | Invictus Bands SystemOWI · Traditional | Alphatec Spine, Inc. | 03/25/2026SE |
| K222097 | OLYMPIC Deformity Band SystemOWI · Traditional | Astura Medical | 05/04/2023SE |
| K230565 | HILINE Fixation SystemOWI · Traditional | Globus Medical, Inc. | 04/20/2023SE |
| K213659 | LigaPASS 2.0 Ligament Augmentation SystemOWI · Traditional | Medicrea International SA | 05/24/2022SE |
| K211057 | LigaPASS® Spinal System, CD Horizon Spinal SystemOWI · Traditional | Medtronic, Inc. | 05/27/2021SE |
| K201240 | Mariner Cap SystemOWI · Traditional | SeaSpine Orthopedics Corporation | 08/05/2020SE |
| K200281 | The Gecko Spinal SystemOWI · Traditional | Ortho Development Corporation | 03/31/2020SE |
| K200097 | Response BandLoc Spinal FixationOWI · Traditional | OrthoPediatrics Corp. | 03/16/2020SE |
| K191217 | Jazz PFOWI · Traditional | Implanet, S.A. | 08/02/2019SE |
| K190289 | Karma® Fixation SystemOWI · Traditional | Spinal Elements, Inc. | 04/03/2019SE |
| K190418 | NuVasive® VersaTie® SystemOWI · Special | Nu Vasive, Incorporated | 03/21/2019SE |
| K180728 | Spinal Elements Cerclage SystemOWI · Traditional | Spinal Elements, Inc. | 09/06/2018SE |
| K181799 | ResCUBE Ligament Fixation SystemOWI · Traditional | Cousin Biotech Sas | 08/29/2018SE |
| K172206 | NAJA Ligament Correction SystemOWI · Traditional | Cousin Biotech Sas | 04/10/2018SE |
| K173506 | LigaPASSOWI · Traditional | Medicrea International SA | 04/03/2018SE |
| K173117 | NuVasive® VersaTie SystemOWI · Traditional | Nuvasive, Inc. | 12/07/2017SE |
| K172417 | SILC® Fixation SystemOWI · Traditional | Globus Medical, Inc. | 10/26/2017SE |
| K172021 | LigaPASSOWI · Traditional | Medicrea International SA | 08/30/2017SE |
| K171881 | JAZZ Passer BandOWI · Traditional | Implanet, S.A. | 08/08/2017SE |
| K170730 | JAZZ System, including JAZZ BandOWI · Traditional | Implanet, S.A. | 06/09/2017SE |
| K163181 | TRANSLACE Spinal Tethering SystemOWI · Traditional | Medtronic Sofamor Danek USA, Inc. | 05/16/2017SE |
| K161332 | NILE Proximal Fixation Spinal SystemOWI · Traditional | K2m, Inc. | 04/05/2017SE |
| K160698 | LigaPASSOWI · Traditional | Medicrea International SA | 09/02/2016SE |
| K161267 | Response BandLoc Spinal FixationOWI · Traditional | OrthoPediatrics Corp. | 08/11/2016SE |
| K161265 | NuVasive® VersaTie SystemOWI · Traditional | Nu Vasive, Incorporated | 07/15/2016SE |
| K153348 | Jazz LockOWI · Traditional | Implanet, S.A. | 03/31/2016SE |
| K160208 | NILE Alternative Fixation Spinal SystemOWI · Special | K2m, Inc. | 03/18/2016SE |
| K151740 | JAZZ SystemOWI · Traditional | Implanet, S.A. | 08/27/2015SE |
| K143759 | JAZZ SystemOWI · Traditional | Implanet, S.A. | 05/07/2015SE |
| K143350 | Nile Alternative FixationOWI · Traditional | K2m, Inc. | 02/25/2015SE |
| K142053 | Universal Clamp Spinal Fixation SystemOWI · Traditional | Zimmer Spine, Inc. | 10/29/2014SE |
| K133482 | Silc Fixation SystemOWI · Traditional | Globus Medical, Inc. | 05/21/2014SE |
| K133617 | Jazz SystemOWI · Traditional | Implanet, S.A. | 02/20/2014SE |
| K132395 | LigapassOWI · Traditional | Medicrea International | 12/06/2013SE |
| K132287 | Jazz SystemOWI · Traditional | Hogan Lovells US LLP | 09/25/2013SE |
| K110348 | Universal Clamp Spinal Fixation SystemOWI · Traditional | Zimmer Spine | 08/11/2011SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0463-2021 Class II | MEDICREA LIGAPASS TENSION PULLEY HANDLE XS- intended to provide thoracic and/or lumbar…Tightening the LIGAPASS Band with this instrument, the tensioner's pliers can crush the band causing the… | Medicrea International | 10/08/2020Terminated |
| Z-2321-2017 Class II | Response BandLoc 5.5/6.0 Tensioner Instrument The Tensioner Instrument (01-1102-1000) is…Over-tensioning of the band resulting in damage to the band causing it to rupture | OrthoPediatrics Corp | 04/24/2017Terminated |