Browse hierarchy: [Orthopedic (OR)](/submissions/OR) → [Subpart D — Prosthetic Devices](/submissions/OR/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 888.3040](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/888.3040) → MBI — Fastener, Fixation, Nondegradable, Soft Tissue # MBI · Fastener, Fixation, Nondegradable, Soft Tissue _Orthopedic · 21 CFR 888.3040 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBI ## Overview - **Product Code:** MBI - **Device Name:** Fastener, Fixation, Nondegradable, Soft Tissue - **Regulation:** [21 CFR 888.3040](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/888.3040) - **Device Class:** 2 - **Review Panel:** [Orthopedic](/submissions/OR) - **Implant:** yes ## Identification A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system. ## Classification Rationale Class II. ## Recent Cleared Devices (20 of 589) Showing 20 most recent of 589 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K260561](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBI/K260561.md) | Arthrex FiberTak Suture Anchor | Arthrex, Inc. | Mar 20, 2026 | SESE | | [K253886](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBI/K253886.md) | Grappler Suture Anchor PCFD Tether System | Paragon 28, Inc. | Mar 17, 2026 | SESE | | [K254176](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBI/K254176.md) | SINEFIX | BAAT Medical Products B.V. | Mar 16, 2026 | SESE | | [K251750](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBI/K251750.md) | Trax EX Anchor | Trax Surgical, Inc. | Mar 12, 2026 | SESE | | [K253693](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBI/K253693.md) | Strut Suture; No-Tie Button | Riverpoint Medical, LLC | Mar 11, 2026 | SESE | | [K260405](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBI/K260405.md) | FiberTape Button | Arthrex, Inc. | Mar 9, 2026 | SESE | | [K253538](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBI/K253538.md) | TeKBrace Knotless Anchor | Theramicro | Mar 6, 2026 | SESE | | [K254306](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBI/K254306.md) | Aevumed FENIX Suture Anchor | Aevumed, Inc. | Mar 4, 2026 | SESE | | [K254229](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBI/K254229.md) | Arthrex Nano FiberTak Suture Anchor | Arthrex, Inc. | Mar 2, 2026 | SESE | | [K253695](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBI/K253695.md) | LigaMend | Riverpoint Medical, LLC | Feb 27, 2026 | SESE | | [K253763](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBI/K253763.md) | Y-Knotless™ Flex Anchors | Conmed Corporation | Jan 29, 2026 | SESE | | [K260004](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBI/K260004.md) | Aevumed PROTEKT Suture Anchor | Aevumed, Inc. | Jan 28, 2026 | SESE | | [K253618](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBI/K253618.md) | QuadLock™ Fixation System | Abanza Tecnomed S.L | Jan 6, 2026 | SESE | | [K253895](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBI/K253895.md) | Arthrex SwiveLock Suture Anchor, 3.5 x 10 mm | Arthrex, Inc. | Dec 30, 2025 | SESE | | [K252596](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBI/K252596.md) | Tigon Medical Knotless and Dual Javelin All-Suture Anchors | Tigon Medical | Dec 4, 2025 | SESE | | [K252664](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBI/K252664.md) | GMReis Suture Anchors | GM Dos Reis Industria e Comercio Ltda. | Nov 4, 2025 | SESE | | [K252314](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBI/K252314.md) | Arthrex SutureTak Suture Anchor | Arthrex, Inc. | Oct 29, 2025 | SESE | | [K253040](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBI/K253040.md) | Aevumed FASE Suture Anchor | Aevumed, Inc. | Oct 21, 2025 | SESE | | [K253010](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBI/K253010.md) | Mini Superhawk Suture Anchor System | Responsive Arthroscopy, LLC | Oct 14, 2025 | SESE | | [K250095](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBI/K250095.md) | All-Suture Dual Anchor System | Suturetech, Inc. | Sep 5, 2025 | SESE | ## Top Applicants - Arthrex, Inc. — 51 clearances - Innovasive Devices, Inc. — 22 clearances - Parcus Medical, LLC — 21 clearances - Smith & Nephew, Inc. — 19 clearances - Arthrocare Corp. — 18 clearances --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBI](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBI) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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