KTT · Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Orthopedic · 21 CFR 888.3030 · Class 2
Overview
| Product Code | KTT |
|---|---|
| Device Name | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component |
| 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 403)
Showing 20 most recent of 403 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K260900 | DYNEX® External Fixation Systems | Vilex, LLC | Apr 17, 2026 | SESE |
| K260112 | QuikFix External Fixator: Knee-Spanning Pack | Stabiliz Orthopaedics, Inc. | Mar 23, 2026 | SESE |
| K253291 | Excelsior System | Blue Ocean Global | Jan 20, 2026 | SESE |
| K253613 | Monkey Rings External Ring Fixation System | Paragon 28, Inc. | Dec 19, 2025 | SESE |
| K253202 | Hoffmann LRF System | Stryker GmbH | Dec 19, 2025 | SESE |
| K252555 | Medusa Orthopedics Boa External Fixation System | Medusa Orthopedics, LLC | Nov 25, 2025 | SESE |
| K252625 | The Response Ortho Smart Fixator - Hexapod System | Response Ortho Solutions, LLC | Nov 20, 2025 | SESE |
| K252106 | External Fixation Mini Rail System | Paragon 28, Inc. | Sep 30, 2025 | SESE |
| K251862 | External Fixation Bone Distractor | Paragon 28, Inc. | Aug 11, 2025 | SESE |
| K250472 | SixFix Hexapod Fixator and Deformity Analysis and Correction Software (DACS) | Amdt Holdings, Inc. | Aug 8, 2025 | SESE |
| K251128 | Extremity Medical External Fixation System | Extremity Medical, LLC | May 7, 2025 | SESE |
| K243798 | Orthex External Fixation System | OrthoPediatrics Corp. | Mar 7, 2025 | SESE |
| K241563 | Extremity Medical External Fixation System | Extremity Medical, LLC | Feb 21, 2025 | SESE |
| K242861 | TrueLok Elevate | Orthofix Srl | Dec 3, 2024 | SESE |
| K242452 | Monkey Bars Pin to Bar External Fixation System | Paragon 28, Inc. | Nov 1, 2024 | SESE |
| K241769 | Response Ortho Metaphyseal Hinge Fixator System | Response Ortho Solutions, LLC | Sep 18, 2024 | SESE |
| K233025 | Revolution External Plating System | New Standard Device Dba Metalogix | May 30, 2024 | SESE |
| K240049 | LINK(TM) External Fixator | Metric Medical Devices, Inc. | May 29, 2024 | SESE |
| K233741 | Hoffmann LRF System | Stryker GmbH | Dec 21, 2023 | SESE |
| K221787 | Auxein's DHS/DCS Plate System | Auxein Medical Private Limited | Nov 30, 2023 | SESE |
Top Applicants
- Ebi, L.P. — 35 clearances
- Synthes (Usa) — 31 clearances
- Howmedica Corp. — 20 clearances
- Howmedica Osteonics Corp. — 19 clearances
- Smith & Nephew, Inc. — 15 clearances
