MAI · Fastener, Fixation, Biodegradable, Soft Tissue
Orthopedic · 21 CFR 888.3030 · Class 2
Overview
| Product Code | MAI |
|---|---|
| Device Name | Fastener, Fixation, Biodegradable, Soft Tissue |
| Regulation | 21 CFR 888.3030 |
| Device Class | Class 2 |
| Review Panel | Orthopedic |
| Implant | Yes |
Identification
Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached 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 219)
Showing 20 most recent of 219 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K260294 | SF Push-in Anchor | Surgical Fusion Technologies GmbH | Mar 27, 2026 | SESE |
| K254055 | OSSIOfiber® Suture Anchor | OSSIO , Ltd. | Feb 24, 2026 | SESE |
| K251680 | Biosteon® Screw | Biocomposites, Ltd. | Feb 17, 2026 | SESE |
| K252946 | BioBrace® Extra-Articular Ligament Augmentation Kit | Conmed Corporation | Oct 15, 2025 | SESE |
| K252022 | OSSIOfiber® Interference Screw | OSSIO , Ltd. | Aug 19, 2025 | SESE |
| K251309 | OSSIOfiber® Suture Anchor | OSSIO , Ltd. | May 27, 2025 | SESE |
| K250544 | Knotilus+ Biocomposite Knotless Anchor | Stryker Endoscopy | May 23, 2025 | SESE |
| K250528 | Stryker AlphaVent Knotless SP Biocomposite Anchor | Stryker Endoscopy | May 21, 2025 | SESE |
| K243760 | OSSIOfiber® Suture Anchor 2.5-3.5 mm | OSSIO , Ltd. | Apr 3, 2025 | SESE |
| K250526 | Arthrex 4.75 mm Double Loaded Knotless Corkscrew Suture Anchor | Arthrex, Inc. | Mar 14, 2025 | SESE |
| K243790 | GRYPHON X Anchor; HEALIX TRANSTEND Anchor | Depuy Mitek | Feb 5, 2025 | SESE |
| K243467 | Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching) | Osteonic Co., Ltd. | Dec 3, 2024 | SESE |
| K241010 | HEALIX ADVANCE Knotless anchors; HEALIX ADVANCE Self-Punching anchors | Depuy Mitek | Sep 11, 2024 | SESE |
| K241912 | BIOCHARGE | Nanofiber Solutions, LLC | Jul 29, 2024 | SESE |
| K233971 | Arthrex AlloSync PushLock Suture Anchor | Arthrex, Inc. | Jun 4, 2024 | SESE |
| K240288 | SF Push- in Anchor | Surgical Fusion Technologies GmbH | Apr 1, 2024 | SESE |
| K240441 | MILAGRO Interference Screw; MILAGRO ADVANCE Interference Screw | Depuy Mitek | Mar 15, 2024 | SESE |
| K240090 | Argo Knotless GENESYS Anchor | Conmed Corporation | Mar 5, 2024 | SESE |
| K232513 | X-Twist Biocomposite Suture Anchor | Parcus Medical | Sep 18, 2023 | SESE |
| K231787 | ecoFIX® | Science & Bio Materials (S.B.M.) Sas | Jul 26, 2023 | SESE |
Top Applicants
- Arthrex, Inc. — 44 clearances
- Depuy Mitek, A Johnson & Johnson Company — 18 clearances
- Linvatec Corp. — 11 clearances
- Smith & Nephew, Inc. — 10 clearances
- Medos International SARL — 8 clearances
