Orthofix Galaxy Unyco Diaphyseal Tibia KIT
The Orthofix Galaxy UNYCO Diaphyseal Tibia Kit is an external fixation system for temporary stabilization of tibial fractures before definitive treatment. It is intended for…
The Orthofix Galaxy UNYCO Diaphyseal Tibia Kit is an external fixation system for temporary stabilization of tibial fractures before definitive treatment. It is intended for non-weight-bearing use in trauma care, rather than supporting the stresses of walking.
The kit includes UNYCO screws, cancellous screws, multiscrew clamps, 12 mm rods and application tools. These modular components form an external frame, with different configurations available for stabilizing the injured tibia during the temporary treatment period.
Listed Item
Galaxy Unyco Diaphyseal Tibia Sterile KIT
Treatment Scope
The indications cover tibial fractures from approximately 8 cm below the knee to 7 cm above the ankle, including open or closed comminuted fractures and polytrauma. Temporary stabilization after debridement for osteomyelitis or infected nonunion is also included.
Who Else Makes It
Concentrated in Jiangsu (6), Shanghai (4), Zhejiang (3). 13 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Suzhou Ahno Medical Devices Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 17 |
| Turnxon Precision Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 17 |
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Stryker Orthmed (Changzhou) Medical Instrument Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 10 |
| Hangzhou Sino-MIM Technology Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 6 |
| Suzhou AND Science & Technology Development Corp. | Zhangjiagang | Jiangsu | Contract manufacturer | 5 |
Showing 12 of 17. All 17 manufacturers in China registered for Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Record
| Listed by | Orthofix SRL, Italy |
|---|---|
| FDA product code | KTT |
| Device type | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3030 |
| Establishment | Manufacturer, Exporter |
| 510(k) | K142052 |
| Record published | 2015-09-01 |
| Record revised | 2026-06-24 (version 8) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Smart Correction | Wishbone Medical Inc. | 1,534 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | Synthes Gmbh | 880 |
| LCP | Synthes Gmbh | 355 |
| Orthex External Fixation System | Orthopediatrics, Corp | 353 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | Sterilmed, Inc. | 325 |
| CHS | Smith & Nephew, Inc. | 321 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | Stryker Sustainability Solutions | 277 |
| Hoffmann | Stryker GmbH | 239 |
| Orthex | Orthopediatrics, Corp | 231 |
| Orthex | Vilex IN Tennessee, Inc. | 221 |
| Omega | Stryker GmbH | 212 |
| eZ-Fix | Orthopediatrics, Corp | 207 |
Showing 12 of 530. All products under Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K242861 | 2024-12-03 |
| K212044 | 2021-11-05 |
| K170146 | 2017-10-12 |
| K170650 | 2017-05-10 |
| K153233 | 2016-01-06 |
| K152171 | 2015-09-28 |
| K143125 | 2014-12-10 |
| K141760 | 2014-12-08 |
| K142052 | 2014-12-05 |
| K141078 | 2014-09-02 |
| K113770 | 2012-09-04 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Orthofix SRL | 510(k) number | 2017-07-05 | Class II | Process change control | The power drill torque limiter may break during use in surgery application. | 416 units | 2023-01-13 |
Recalls
11 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2018-09-27 | Class II | Device Design | As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower cutting performance. | 2022-02-01 | |
| 2018-09-27 | Class II | Device Design | As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower cutting performance. | 2022-02-01 | |
| 2018-09-27 | Class II | Device Design | As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower cutting performance. | 2022-02-01 | |
| 2018-09-27 | Class II | Device Design | As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower cutting performance. | 2022-02-01 | |
| 2018-09-27 | Class II | Device Design | As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower cutting performance. | 2022-02-01 | |
| 2018-09-27 | Class II | Device Design | As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower cutting performance. | 2022-02-01 | |
| 2018-09-27 | Class II | Device Design | As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower cutting performance. | 2022-02-01 | |
| 2018-09-27 | Class II | Device Design | As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower cutting performance. | 2022-02-01 | |
| 2018-09-27 | Class II | Device Design | As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower cutting performance. | 2022-02-01 | |
| 2018-09-27 | Class II | Device Design | As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower cutting performance. | 2022-02-01 | |
| 2018-01-30 | Class II | Device Design | The firm received complaints regarding the incompatibility and dimensional interference between the double row footplates manufactured in a limited period of 2014 and struts manufactured after September 2016. The firm determined that cert | 408 units | 2021-05-13 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.