Browse hierarchy: [Orthopedic (OR)](/submissions/OR) → [Subpart D — Prosthetic Devices](/submissions/OR/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 888.3010](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/888.3010) → OWI — Bone Fixation Cerclage, Sublaminar # OWI · Bone Fixation Cerclage, Sublaminar _Orthopedic · 21 CFR 888.3010 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/OWI ## Overview - **Product Code:** OWI - **Device Name:** Bone Fixation Cerclage, Sublaminar - **Regulation:** [21 CFR 888.3010](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/888.3010) - **Device Class:** 2 - **Review Panel:** [Orthopedic](/submissions/OR) - **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](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/OWI/K253615.md) | Invictus Bands System | Alphatec Spine, Inc. | Mar 25, 2026 | SESE | | [K222097](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/OWI/K222097.md) | OLYMPIC Deformity Band System | Astura Medical | May 4, 2023 | SESE | | [K230565](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/OWI/K230565.md) | HILINE™ Fixation System | Globus Medical, Inc. | Apr 20, 2023 | SESE | | [K213659](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/OWI/K213659.md) | LigaPASS™ 2.0 Ligament Augmentation System | Medicrea International SA | May 24, 2022 | SESE | | [K211057](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/OWI/K211057.md) | LigaPASS® Spinal System, CD Horizon™ Spinal System | Medtronic, Inc. | May 27, 2021 | SESE | | [K201240](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/OWI/K201240.md) | Mariner Cap System | SeaSpine Orthopedics Corporation | Aug 5, 2020 | SESE | | [K200281](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/OWI/K200281.md) | The Gecko Spinal System | Ortho Development Corporation | Mar 31, 2020 | SESE | | [K200097](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/OWI/K200097.md) | Response BandLoc Spinal Fixation | OrthoPediatrics Corp. | Mar 16, 2020 | SESE | | [K191217](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/OWI/K191217.md) | JAZZ PF | Implanet, S.A. | Aug 2, 2019 | SESE | | [K190289](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/OWI/K190289.md) | Karma® Fixation System | Spinal Elements, Inc. | Apr 3, 2019 | SESE | | [K190418](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/OWI/K190418.md) | NuVasive® VersaTie® System | Nu Vasive, Incorporated | Mar 21, 2019 | SESE | | [K180728](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/OWI/K180728.md) | Spinal Elements Cerclage System | Spinal Elements, Inc. | Sep 6, 2018 | SESE | | [K181799](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/OWI/K181799.md) | ResCUBE™ Ligament Fixation System | Cousin Biotech Sas | Aug 29, 2018 | SESE | | [K172206](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/OWI/K172206.md) | NAJA™ Ligament Correction System | Cousin Biotech Sas | Apr 10, 2018 | SESE | | [K173506](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/OWI/K173506.md) | LigaPASS | Medicrea International SA | Apr 3, 2018 | SESE | | [K173117](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/OWI/K173117.md) | NuVasive® VersaTie™ System | Nuvasive, Inc. | Dec 7, 2017 | SESE | | [K172417](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/OWI/K172417.md) | SILC® Fixation System | Globus Medical, Inc. | Oct 26, 2017 | SESE | | [K172021](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/OWI/K172021.md) | LigaPASS | Medicrea International SA | Aug 30, 2017 | SESE | | [K171881](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/OWI/K171881.md) | JAZZ Passer Band | Implanet, S.A. | Aug 8, 2017 | SESE | | [K170730](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/OWI/K170730.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/OWI](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/OWI) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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