Product code KTT
- Device name
- Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
- Medical specialty
- Orthopedic
- Device class
- 2
- Regulation number
- 888.3030
- Review panel
- OR
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K254087 | MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction System | Synthes (USA) Products, LLC | 2026-06-11 |
| K260900 | DYNEX® External Fixation Systems | Vilex, LLC | 2026-04-17 |
| K260112 | QuikFix External Fixator: Knee-Spanning Pack | Stabiliz Orthopaedics, Inc. | 2026-03-23 |
| K253291 | Excelsior System | Blue Ocean Global | 2026-01-20 |
| K253202 | Hoffmann LRF System | Stryker GmbH | 2025-12-19 |
| K253613 | Monkey Rings External Ring Fixation System | Paragon 28, Inc. | 2025-12-19 |
| K252555 | Medusa Orthopedics Boa External Fixation System | Medusa Orthopedics, LLC | 2025-11-25 |
| K252625 | The Response Ortho Smart Fixator - Hexapod System | Response Ortho Solutions, LLC | 2025-11-20 |
| K252106 | External Fixation Mini Rail System | Paragon 28, Inc. | 2025-09-30 |
| K251862 | External Fixation Bone Distractor | Paragon 28, Inc. | 2025-08-11 |
| K250472 | SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS) | Amdt Holdings, Inc. | 2025-08-08 |
| K251128 | Extremity Medical External Fixation System | Extremity Medical, LLC | 2025-05-07 |
| K243798 | Orthex External Fixation System | OrthoPediatrics Corp. | 2025-03-07 |
| K241563 | Extremity Medical External Fixation System | Extremity Medical, LLC | 2025-02-21 |
| K242861 | TrueLok Elevate | Orthofix Srl | 2024-12-03 |
| K242452 | Monkey Bars Pin to Bar External Fixation System | Paragon 28, Inc. | 2024-11-01 |
| K241769 | Response Ortho Metaphyseal Hinge Fixator System | Response Ortho Solutions, LLC | 2024-09-18 |
| K233025 | Revolution External Plating System | New Standard Device Dba Metalogix | 2024-05-30 |
| K240049 | LINK(TM) External Fixator | Metric Medical Devices, Inc. | 2024-05-29 |
| K233741 | Hoffmann LRF System | Stryker GmbH | 2023-12-21 |
| K221787 | Auxein's DHS/DCS Plate System | Auxein Medical Private Limited | 2023-11-30 |
| K232897 | Arthrex Small External Fixation System | Arthrex, Inc. | 2023-10-18 |
| K232838 | Monkey RingsTM External Fixation System | Paragon 28, Inc. | 2023-10-12 |
| K231922 | DEPUY SYNTHES MAXFRAME AUTOSTRUT System | DePuy Synthes | 2023-07-26 |
| K231461 | Smart Correction System (HA Half Pins) | Wishbone Medical, Inc. | 2023-06-16 |
| K223786 | Orthex External Fixation System | OrthoPediatrics Corp. | 2023-02-10 |
| K213905 | ONX Large External Fixation System | Orthonovis, Inc. | 2022-08-25 |
| K221366 | Smart Correction System Rings and Compatible HA-Coated Half Pins | Wishbone Medical, Inc. | 2022-06-06 |
| K220809 | Drive Rail System | OrthoPediatrics Corp. | 2022-04-08 |
| K212895 | Paragon 28 External Ring Fixation System | Paragon 28, Inc. | 2021-11-08 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10888867544571 | Arthrex® | ARTHREX, INC. | 2026-03-13 |
| 00841132142325 | eZ-Fix | ORTHOPEDIATRICS CORP. | 2020-02-28 |
| 00841132142905 | eZ-Fix | ORTHOPEDIATRICS CORP. | 2020-02-28 |
| 00841132142950 | eZ-Fix | ORTHOPEDIATRICS CORP. | 2020-02-28 |
| 00841132143025 | eZ-Fix | ORTHOPEDIATRICS CORP. | 2020-02-28 |
| 10886982078438 | NA | Synthes GmbH | 2015-09-14 |
| 10886982078582 | NA | Synthes GmbH | 2015-09-14 |
| 10886982078445 | NA | Synthes GmbH | 2015-09-14 |
| 10886982078452 | NA | Synthes GmbH | 2015-09-14 |
| 10886982078469 | NA | Synthes GmbH | 2015-09-14 |
| 10886982078476 | NA | Synthes GmbH | 2015-09-14 |
| 10886982078520 | NA | Synthes GmbH | 2015-09-14 |
| 10886982078537 | NA | Synthes GmbH | 2015-09-14 |
| 10886982078544 | NA | Synthes GmbH | 2015-09-14 |
| 10886982078551 | NA | Synthes GmbH | 2015-09-14 |
| 10886982078568 | NA | Synthes GmbH | 2015-09-14 |
| 10886982078575 | NA | Synthes GmbH | 2015-09-14 |
| 10886982078261 | NA | Synthes GmbH | 2015-09-14 |
| 10886982078254 | NA | Synthes GmbH | 2015-09-14 |
| 10886982078247 | NA | Synthes GmbH | 2015-09-14 |
| 10886982078209 | NA | Synthes GmbH | 2015-09-14 |
| 10886982078193 | NA | Synthes GmbH | 2015-09-14 |
| 10886982078186 | NA | Synthes GmbH | 2015-09-14 |
| 10886982078155 | NA | Synthes GmbH | 2015-09-14 |
| 10886982078148 | NA | Synthes GmbH | 2015-09-14 |
| 10886982078131 | NA | Synthes GmbH | 2015-09-14 |
| 10886982077899 | NA | Synthes GmbH | 2015-09-14 |
| 10886982077882 | NA | Synthes GmbH | 2015-09-14 |
| 10886982077875 | NA | Synthes GmbH | 2015-09-14 |
| 10886982077868 | NA | Synthes GmbH | 2015-09-14 |