Orthofix Galaxy Fixation System
Orthofix Galaxy is an external fixation family that stabilizes bone using frames, bars and clamps outside the body. Clamps couple the frame to compatible Orthofix pins or wires anchored in…
Orthofix Galaxy is an external fixation family that stabilizes bone using frames, bars and clamps outside the body. Clamps couple the frame to compatible Orthofix pins or wires anchored in bone.
Modular parts form different arrangements for the upper limb, lower limb or pelvis. The frame supports fracture alignment and maintains stabilization through the pin-to-frame connections.
Listed Item
MSF External Fixator SET Orthofix Galaxy Restocking 2020 (REF. KSURBFIXOG12)
Modules and Accessories
Frames, bars, clamps, accessories and application instruments are supplied as parts of the system. Their combination depends on the anatomical site and fixation arrangement. The family supports trauma and orthopedic stabilization in adults and pediatric patients other than newborns.
17manufacturers in China registered for this device type
143catalogue numbers in this listing
11510(k) clearances naming this product code
12recalls on this code
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) | K113770 |
| Record published | 2022-06-03 |
| Record revised | 2026-05-07 (version 8) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Sizes | Length 6 to 650 mm; outer diameter 6 to 250 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1 | Outer Diameter 12 mm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Outer Diameter 12 mm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Length 200 mm | In distribution |
| 1 | In distribution | |
| 1 | Length 100 mm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Outer Diameter 12 mm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Length 100 mm | In distribution |
| 1 | Length 200 mm | In distribution |
| 1 | Length 80 mm | In distribution |
| 1 | Length 350 mm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Length 150 mm | In distribution |
| 1 | Length 250 mm | In distribution |
| 1 | In distribution | |
| 1 | Length 250 mm | In distribution |
| 1 | Length 100 mm | In distribution |
| 1 | In distribution | |
| 1 | Length 200 mm | In distribution |
| 1 | Outer Diameter 12 mm | In distribution |
| 1 | Outer Diameter 12 mm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Outer Diameter 12 mm | In distribution |
| 1 | In distribution | |
| 1 | Length 150 mm | In distribution |
| 1 | Length 400 mm | In distribution |
| 1 | In distribution | |
| 1 | Length 60 mm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Length 150 mm | In distribution |
| 1 | In distribution | |
| 1 | Length 100 mm | In distribution |
| 1 | Length 300 mm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Length 250 mm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Length 160 mm | In distribution |
| 1 | In distribution | |
| 1 | Outer Diameter 12 mm | In distribution |
| 1 | Length 300 mm | In distribution |
| 1 | In distribution | |
| 1 | Length 140 mm | In distribution |
| 1 | Length 12 mm | In distribution |
| 1 | Outer Diameter 12 mm | In distribution |
| 1 | Length 50 mm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Length 180 mm | In distribution |
| 1 | Length 250 mm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Length 100 mm | In distribution |
| 1 | Length 200 mm | In distribution |
| 1 | In distribution | |
| 1 | Length 200 mm | In distribution |
| 1 | In distribution | |
| 1 | Length 100 mm | In distribution |
| 1 | Outer Diameter 12 mm | In distribution |
| 1 | In distribution | |
| 1 | Outer Diameter 12 mm | In distribution |
| 1 | Length 120 mm | In distribution |
| 1 | In distribution | |
| 1 | Length 160 mm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Length 6 mm | In distribution |
| 1 | Length 215 mm | In distribution |
| 1 | In distribution | |
| 1 | Length 140 mm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Length 100 mm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Length 120 mm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Length 180 mm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Length 300 mm | In distribution |
| 1 | Outer Diameter 180 mm | In distribution |
| 1 | In distribution | |
| 1 | Length 60 mm | In distribution |
| 1 | Length 180 mm | In distribution |
| 1 | Length 80 mm | In distribution |
| 1 | In distribution | |
| 1 | Length 200 mm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Length 50 mm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Length 6 mm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Length 12 mm | 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
13 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Orthofix US LLC | 510(k) number | 2026-06-10 | Class II | Process change control | Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was labeled as M111 | 48 units | |
| Orthofix US LLC | 510(k) number | 2026-06-10 | Class II | Process change control | Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was labeled as M111 | 19 units | |
| Orthofix US LLC | 510(k) number | 2026-06-10 | Class II | Process change control | Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was labeled as M111 | 32 units | |
| Orthofix US LLC | 510(k) number | 2026-06-10 | Class II | Process change control | Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was labeled as M111 | 62 units | |
| Orthofix SRL | 510(k) number | 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 | |
| Orthofix SRL | 510(k) number | 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 | |
| Orthofix SRL | 510(k) number | 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 | |
| Orthofix SRL | 510(k) number | 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 | |
| Orthofix SRL | 510(k) number | 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 | |
| Orthofix SRL | 510(k) number | 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 | |
| Orthofix SRL | 510(k) number | 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 | |
| Orthofix SRL | 510(k) number | 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 | |
| Orthofix SRL | 510(k) number | 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 |
Recalls
3 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 | |
| 2018-01-30 | 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 |
| 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 |
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.