OWI · Bone Fixation Cerclage, Sublaminar
Orthopedic · 21 CFR 888.3010 · Class 2
Overview
| Product Code | OWI |
|---|---|
| Device Name | Bone Fixation Cerclage, Sublaminar |
| Regulation | 21 CFR 888.3010 |
| Device Class | Class 2 |
| Review Panel | Orthopedic |
| Implant | Yes |
Identification
A bone fixation cerclage is a device intended to be implanted that is made of alloys, such as cobalt-chromium-molybdenum, and that consists of a metallic ribbon or flat sheet or a wire. The device is wrapped around the shaft of a long bone, anchored to the bone with wire or screws, and used in the fixation of fractures.
Classification Rationale
Class II.
Cleared Devices (36)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K253615 | Invictus Bands System | Alphatec Spine, Inc. | Mar 25, 2026 | SESE |
| K222097 | OLYMPIC Deformity Band System | Astura Medical | May 4, 2023 | SESE |
| K230565 | HILINE Fixation System | Globus Medical, Inc. | Apr 20, 2023 | SESE |
| K213659 | LigaPASS 2.0 Ligament Augmentation System | Medicrea International SA | May 24, 2022 | SESE |
| K211057 | LigaPASS® Spinal System, CD Horizon Spinal System | Medtronic, Inc. | May 27, 2021 | SESE |
| K201240 | Mariner Cap System | SeaSpine Orthopedics Corporation | Aug 5, 2020 | SESE |
| K200281 | The Gecko Spinal System | Ortho Development Corporation | Mar 31, 2020 | SESE |
| K200097 | Response BandLoc Spinal Fixation | OrthoPediatrics Corp. | Mar 16, 2020 | SESE |
| K191217 | JAZZ PF | Implanet, S.A. | Aug 2, 2019 | SESE |
| K190289 | Karma® Fixation System | Spinal Elements, Inc. | Apr 3, 2019 | SESE |
| K190418 | NuVasive® VersaTie® System | Nu Vasive, Incorporated | Mar 21, 2019 | SESE |
| K180728 | Spinal Elements Cerclage System | Spinal Elements, Inc. | Sep 6, 2018 | SESE |
| K181799 | ResCUBE Ligament Fixation System | Cousin Biotech Sas | Aug 29, 2018 | SESE |
| K172206 | NAJA Ligament Correction System | Cousin Biotech Sas | Apr 10, 2018 | SESE |
| K173506 | LigaPASS | Medicrea International SA | Apr 3, 2018 | SESE |
| K173117 | NuVasive® VersaTie System | Nuvasive, Inc. | Dec 7, 2017 | SESE |
| K172417 | SILC® Fixation System | Globus Medical, Inc. | Oct 26, 2017 | SESE |
| K172021 | LigaPASS | Medicrea International SA | Aug 30, 2017 | SESE |
| K171881 | JAZZ Passer Band | Implanet, S.A. | Aug 8, 2017 | SESE |
| K170730 | JAZZ System, including JAZZ Band | Implanet, S.A. | Jun 9, 2017 | SESE |
| K163181 | TRANSLACE Spinal Tethering System | Medtronic Sofamor Danek USA, Inc. | May 16, 2017 | SESE |
| K161332 | NILE Proximal Fixation Spinal System | K2m, Inc. | Apr 5, 2017 | SESE |
| K160698 | LigaPASS | Medicrea International SA | Sep 2, 2016 | SESE |
| K161267 | Response BandLoc Spinal Fixation | OrthoPediatrics Corp. | Aug 11, 2016 | SESE |
| K161265 | NuVasive® VersaTie System | Nu Vasive, Incorporated | Jul 15, 2016 | SESE |
| K153348 | JAZZ LOCK | Implanet, S.A. | Mar 31, 2016 | SESE |
| K160208 | NILE Alternative Fixation Spinal System | K2m, Inc. | Mar 18, 2016 | SESE |
| K151740 | JAZZ System | Implanet, S.A. | Aug 27, 2015 | SESE |
| K143759 | JAZZ System | Implanet, S.A. | May 7, 2015 | SESE |
| K143350 | Nile Alternative Fixation | K2m, Inc. | Feb 25, 2015 | SESE |
| K142053 | UNIVERSAL CLAMP SPINAL FIXATION SYSTEM | Zimmer Spine, Inc. | Oct 29, 2014 | SESE |
| K133482 | SILC FIXATION SYSTEM | Globus Medical, Inc. | May 21, 2014 | SESE |
| K133617 | JAZZ SYSTEM | Implanet, S.A. | Feb 20, 2014 | SESE |
| K132395 | LIGAPASS | Medicrea International | Dec 6, 2013 | SESE |
| K132287 | JAZZ SYSTEM | Hogan Lovells US LLP | Sep 25, 2013 | SESE |
| K110348 | UNIVERSAL CLAMP SPINAL FIXATION SYSTEM | Zimmer Spine | Aug 11, 2011 | SESE |
Top Applicants
- Implanet, S.A. — 7 clearances
- Medicrea International SA — 4 clearances
- K2m, Inc. — 3 clearances
- Globus Medical, Inc. — 3 clearances
- Spinal Elements, Inc. — 2 clearances
