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-staging.innolitics.com/productcode/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 603)

Showing 20 most recent of 603 cleared devices.

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K262809](/device/K262809.md) | ArthroTAK Tendon Anchor Kit | ArthroTAK, LLC | Sep 2, 2026 | SESE |
| [K253065](/device/K253065.md) | Aevumed SUPERCYNCH™ Button System | Aevumed, Inc. | Sep 2, 2026 | SESE |
| [K262677](/device/K262677.md) | Iconix Knotless T | Riverpoint Medical | Aug 27, 2026 | SESE |
| [K262047](/device/K262047.md) | Grappler Suture Anchor System | Paragon 28, Inc. | Aug 3, 2026 | SESE |
| [K262369](/device/K262369.md) | AIR+ All-Inside Meniscal Repair Device, Curved Up;AIR+ All-Inside Meniscal Repair Device, Curved Down | Stryker Endoscopy | Jul 30, 2026 | SESE |
| [K261770](/device/K261770.md) | Suture Button Repair System | Skeletal Dynamics, Inc. | Jul 29, 2026 | SESE |
| [K261632](/device/K261632.md) | Thunderbolt System | Responsive Arthroscopy, Inc. | Jul 20, 2026 | SESE |
| [K261968](/device/K261968.md) | Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE suture (72205981); Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one blue knotless and one black MINITAPE suture (72205982) | Smith & Nephew, Inc. | Jul 9, 2026 | SESE |
| [K260018](/device/K260018.md) | Arthrex FiberButton | Arthrex, Inc. | Jun 26, 2026 | SESE |
| [K253130](/device/K253130.md) | Dione PEEK Screw System | ZheJiang Decans Medical Devices Co., Ltd. | May 27, 2026 | SESE |
| [K261363](/device/K261363.md) | Y-Knotless™ Flex Anchors | CONMED Corporation | May 13, 2026 | SESE |
| [K253027](/device/K253027.md) | Anchor with Fiber Wire and Disposable Inserter | Ortobio S.A. | May 6, 2026 | SESE |
| [K252635](/device/K252635.md) | ArthroTAK Tendon Anchor Kit | ArthroTAK, LLC | May 1, 2026 | SESE |
| [K260921](/device/K260921.md) | Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor Line | Tigon Medical | Apr 21, 2026 | SESE |
| [K260561](/device/K260561.md) | Arthrex FiberTak Suture Anchor | Arthrex, Inc. | Mar 20, 2026 | SESE |
| [K253886](/device/K253886.md) | Grappler Suture Anchor PCFD Tether System | Paragon 28, Inc. | Mar 17, 2026 | SESE |
| [K254176](/device/K254176.md) | SINEFIX | BAAT Medical Products B.V. | Mar 16, 2026 | SESE |
| [K251750](/device/K251750.md) | Trax EX Anchor | Trax Surgical, Inc. | Mar 12, 2026 | SESE |
| [K253693](/device/K253693.md) | Strut Suture; No-Tie Button | Riverpoint Medical, LLC | Mar 11, 2026 | SESE |
| [K260405](/device/K260405.md) | FiberTape Button | Arthrex, Inc. | Mar 9, 2026 | SESE |

## Top Applicants

- Arthrex, Inc. — 52 clearances
- Innovasive Devices, Inc. — 22 clearances
- Parcus Medical, LLC — 21 clearances
- Smith & Nephew, Inc. — 20 clearances
- Arthrocare Corp. — 18 clearances

---

**Source:** [https://fda-staging.innolitics.com/productcode/MBI](https://fda-staging.innolitics.com/productcode/MBI)

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