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.
Recent Cleared Devices (20 of 36)
Showing 20 most recent of 36 cleared devices.
| 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 |
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
