VariAx
X-RAY Template, Dist. LAT. Fibula Plate
17manufacturers in China registered for this device type
8catalogue numbers in this listing
11510(k) clearances naming this product code
15recalls 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 | Stryker GmbH, Switzerland |
|---|---|
| FDA product code | KTT |
| Device type | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3030 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| Record published | 2015-09-24 |
| Record revised | 2025-11-20 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Sizes | Length 77 to 300 mm; width 430 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 40-20908 | Number of Screw Holes: 8.0 Holes | In distribution |
| 45-90001 | Length 300.0 mm | In distribution |
| 40-20904 | Length 89.0 mm | In distribution |
| 40-20909 | Length 149.0 mm | In distribution |
| 40-20905 | Length 101.0 mm | In distribution |
| 40-20903 | Length 77.0 mm | In distribution |
| 40-20906 | Number of Screw Holes: 6.0 Holes | In distribution |
| 40-20907 | Number of Screw Holes: 7.0 Holes | 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 |
|---|---|
| K253202 | 2025-12-19 |
| K233741 | 2023-12-21 |
| K203568 | 2021-02-01 |
| K182968 | 2019-01-25 |
| K163656 | 2017-04-14 |
| K161753 | 2016-11-15 |
| K153377 | 2016-04-11 |
| K122284 | 2012-10-24 |
| K121252 | 2012-07-25 |
| K113327 | 2012-03-29 |
| K111786 | 2012-01-26 |
Recalls
15 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 |
|---|---|---|---|---|---|
| 2026-07-01 | Class II | Device Design | Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization. | 9,658 units | |
| 2026-07-01 | Class II | Device Design | Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization. | 5,439 units | |
| 2026-07-01 | Class II | Device Design | Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization. | 5,664 units | |
| 2026-07-01 | Class II | Device Design | Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization. | 4,505 units | |
| 2026-07-01 | Class II | Device Design | Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization. | 9,405 units | |
| 2026-07-01 | Class II | Device Design | Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization. | 7,571 units | |
| 2026-07-01 | Class II | Device Design | Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization. | 6,244 units | |
| 2024-05-09 | Class II | Process change control | The adjustment ring on the device may become loose resulting in the wire tension not being able to be set correctly. | 39 devices | |
| 2023-02-07 | Class II | Process change control | Stryker has identified a nonconformance in specific lots of Hoffmann LRF Bone Transport Struts. Specifically, the thread pitch is oversized at the distal end of the threaded rod, and as a result the distal ring fixation cannot be locked bet | 488 units | |
| 2018-08-28 | Class II | Under Investigation by firm | The press fit connection of the Angular Sleeve and pin of the U-Joint and Click Lock did not meet specification. A dimensional discrepancy of the bore hole of the Angular Sleeve may cause a reduced press fit of the pin. This can result in p | 1355 | 2021-02-04 |
| 2018-08-28 | Class II | Under Investigation by firm | The press fit connection of the Angular Sleeve and pin of the U-Joint and Click Lock did not meet specification. A dimensional discrepancy of the bore hole of the Angular Sleeve may cause a reduced press fit of the pin. This can result in p | 832 | 2021-02-04 |
| 2018-08-28 | Class II | Under Investigation by firm | The press fit connection of the Angular Sleeve and pin of the U-Joint and Click Lock did not meet specification. A dimensional discrepancy of the bore hole of the Angular Sleeve may cause a reduced press fit of the pin. This can result in p | 867 | 2021-02-04 |
| 2018-08-28 | Class II | Under Investigation by firm | The press fit connection of the Angular Sleeve and pin of the U-Joint and Click Lock did not meet specification. A dimensional discrepancy of the bore hole of the Angular Sleeve may cause a reduced press fit of the pin. This can result in p | 578 | 2021-02-04 |
| 2018-07-26 | Class II | Under Investigation by firm | When creating a correction plan with the Correct Axial First button selected and the No. of corrections per day set to more than 1 (e.g., 2, 3, or 4), the Hexapod Software computes an erroneously accelerated correction plan for the axial | 233 | 2020-05-26 |
| 2018-03-12 | Class II | Labeling mix-ups | The wrong parts were picked for packaging. The connecting Nuts were packed in the packaging labeled with Hinge coupling | 18 | 2020-05-21 |
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.