AxSOS 3
AxSOS 3 is an internal bone-fixation family combining plates, screws and associated instruments. Plate shape, orientation and length vary with the anatomical region and the selected system.…
AxSOS 3 is an internal bone-fixation family combining plates, screws and associated instruments. Plate shape, orientation and length vary with the anatomical region and the selected system.
The AF range addresses ankle fusion, while the Ti range addresses long-bone fracture fixation. A listed screw is one fastener component within this broader plate-and-screw family.
Listed Item
Cannulated Screw – 16mm thread
Implants and Supply
The described implants are titanium alloy with Type II anodization. Applicable screw-and-plate geometries provide locking fixation. Sterile and nonsterile forms are available, with compatible screws and instruments selected for the particular plate system.
Who Else Makes It
Concentrated in Jiangsu (10), Shanghai (4), Zhejiang (3). 12 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 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Suzhou Kangli Orthopaedics Instrument Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 11 |
| Kingj Medical Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 7 |
| Hangzhou Sino-MIM Technology Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 6 |
| Suzhou AND Science & Technology Development Corp. | Zhangjiagang | Jiangsu | Contract manufacturer | 5 |
| Beijing AK Medical Co., Ltd. | Changping District | Beijing | Contract manufacturer | 3 |
Showing 12 of 22. All 22 manufacturers in China registered for Plate, Fixation, Bone
Record
| Listed by | Stryker GmbH, Switzerland |
|---|---|
| FDA product code | HRS |
| Device type | Plate, Fixation, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3030 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K200398 |
| Record published | 2020-07-13 |
| Record revised | 2026-02-23 (version 7) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Sizes | Length 12 to 130 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 666205 | Length 105.0 mm | In distribution |
| 666128 | Length 28.0 mm | In distribution |
| 666440 | Diameter: 6.5 Millimeter | In distribution |
| 666114 | Length 14.0 mm | In distribution |
| 666200 | Length 100.0 mm | In distribution |
| 666455 | Length 55.0 mm | In distribution |
| 630114 | Side: RIGHT | In distribution |
| 666190 | Length 90.0 mm | In distribution |
| 630102 | Side: RIGHT | In distribution |
| 666500 | Length 100.0 mm | In distribution |
| 630111 | Side: LEFT | In distribution |
| 666116 | Length 16.0 mm | In distribution |
| 666685 | Diameter: 6.5 Millimeter | In distribution |
| 666148 | Length 48.0 mm | In distribution |
| 666160 | Diameter: 4.0 Millimeter | In distribution |
| 666140 | Length 40.0 mm | In distribution |
| 666675 | Length 75.0 mm | In distribution |
| 666112 | Diameter: 4.0 Millimeter | In distribution |
| 666175 | Diameter: 4.0 Millimeter | In distribution |
| 630101 | Side: LEFT | In distribution |
| 630104S | Side: RIGHT | In distribution |
| 666730 | Length 130.0 mm | In distribution |
| 666695 | Length 95.0 mm | In distribution |
| 666700 | Diameter: 6.5 Millimeter | In distribution |
| 666470 | Diameter: 6.5 Millimeter | In distribution |
| 666705 | Length 105.0 mm | In distribution |
| 666490 | Diameter: 6.5 Millimeter | In distribution |
| 666180 | Length 80.0 mm | In distribution |
| 666134 | Diameter: 4.0 Millimeter | In distribution |
| 666136 | Length 36.0 mm | In distribution |
| 666185 | Diameter: 4.0 Millimeter | In distribution |
| 630111S | Side: LEFT | In distribution |
| 666435 | Diameter: 6.5 Millimeter | In distribution |
| 630113 | Side: LEFT | In distribution |
| 666690 | Diameter: 6.5 Millimeter | In distribution |
| 666144 | Diameter: 4.0 Millimeter | In distribution |
| 666460 | Length 60.0 mm | In distribution |
| 666495 | Diameter: 6.5 Millimeter | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Pectus System | Biomet Microfixation | 4,662 |
| Arthrex® | Arthrex, Inc. | 3,031 |
| Evos | Smith & Nephew, Inc. | 2,235 |
| Peri-Loc | Smith & Nephew, Inc. | 2,196 |
| OsteoMed | Osteomed | 1,961 |
| VariAx | Stryker GmbH | 1,934 |
| Aptus | Medartis Inc. | 1,688 |
| TC-100 | Smith & Nephew, Inc. | 1,639 |
| Plate, Fixation, Bone | Synthes Gmbh | 1,613 |
| Anthem | Globus Medical, Inc. | 1,551 |
| Acumed | Acumed LLC | 1,360 |
| Signex | Osteonic Co., Ltd. | 1,310 |
Showing 12 of 3,530. All products under Plate, Fixation, Bone
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K242445 | 2024-10-06 |
| K233919 | 2024-03-25 |
| K231257 | 2023-08-18 |
| K231262 | 2023-08-18 |
| K222381 | 2023-04-27 |
| K223772 | 2023-04-07 |
| K221346 | 2022-07-08 |
| K212581 | 2022-01-19 |
| K200398 | 2020-06-05 |
| K192675 | 2019-11-22 |
| K191412 | 2019-08-23 |
| K183172 | 2019-03-05 |
| K181091 | 2018-10-11 |
| K172148 | 2018-03-19 |
| K172350 | 2017-12-15 |
| K170727 | 2017-06-22 |
| K170771 | 2017-05-08 |
| K162841 | 2017-02-21 |
| K162439 | 2017-02-03 |
| K153379 | 2016-05-26 |
| K151769 | 2015-10-27 |
| K151879 | 2015-08-06 |
| K113109 | 2011-12-23 |
| K112926 | 2011-12-19 |
| K110476 | 2011-03-18 |
Recalls
1 of these is 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 |
|---|---|---|---|---|---|
| 2019-12-05 | Class II | Under Investigation by firm | Instrument can break at the level of the thread when being exposed to high forces during nail implantation or removal which can lead to complications during nail insertion and removal. | 433 (289 units U.S. / 144 units OUS) | 2020-10-09 |
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.