Axsos
Aiming Block Ti Prox. Lat. Humerus, Right
22manufacturers in China registered for this device type
935catalogue numbers in this listing
25510(k) clearances naming this product code
1recall
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) | K050512 |
| Record published | 2015-09-24 |
| Record revised | 2025-11-20 (version 12) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Sizes | Length 8 to 415 mm |
| Distribution end date | 2025-12-31 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 427044S | Length 168.0 mm | In distribution |
| 371528 | Length 28.0 mm | In distribution |
| 371030 | Diameter: 3.0 Millimeter | In distribution |
| 627464 | Length 229.0 mm | In distribution |
| 437352S | Screw Holes: 22.0 Holes | In distribution |
| 661780 | Length 80.0 mm | In distribution |
| 427141 | Length 209.0 mm | In distribution |
| 627509S | Number of Screw Holes: 9.0 Holes | In distribution |
| 661055S | Diameter: 4.0 Millimeter | In distribution |
| 661455S | Diameter: 3.5 Millimeter | In distribution |
| 427011S | Screw Holes: 11.0 Holes | In distribution |
| 427114 | Length 259.0 mm | In distribution |
| 627636S | Screw Holes: 6.0 Holes | In distribution |
| 661724S | Diameter: 4.5 Millimeter | In distribution |
| 627412 | Length 201.0 mm | In distribution |
| 661140 | Diameter: 5.0 Millimeter | In distribution |
| 661722S | Diameter: 4.5 Millimeter | In distribution |
| 661448S | Length 48.0 mm | In distribution |
| 661165S | Diameter: 5.0 Millimeter | In distribution |
| 627212 | Length 202.0 mm | In distribution |
| 661146 | Length 46.0 mm | In distribution |
| 661480S | Diameter: 3.5 Millimeter | In distribution |
| 371028 | Length 28.0 mm | In distribution |
| 661410S | Length 10.0 mm | In distribution |
| 427014S | Screw Holes: 14.0 Holes | In distribution |
| 437306 | Length 147.0 mm | In distribution |
| 661495 | Diameter: 3.5 Millimeter | In distribution |
| 661490S | Length 90.0 mm | In distribution |
| 661165 | Length 65.0 mm | In distribution |
| 627502S | Length 32.0 mm | In distribution |
| 371334 | Length 34.0 mm | In distribution |
| 608350S | Diameter: 6.0 Millimeter | In distribution |
| 661825 | Diameter: 4.5 Millimeter | In distribution |
| 437326 | Length 147.0 mm | In distribution |
| 627614 | Screw Holes: 14.0 Holes | In distribution |
| 427146 | Length 299.0 mm | In distribution |
| 627648S | Screw Holes: 18.0 Holes | In distribution |
| 661850 | Length 150.0 mm | In distribution |
| 661720S | Diameter: 4.5 Millimeter | In distribution |
| 608315S | Length 115.0 mm | In distribution |
| 427003S | Length 45.0 mm | In distribution |
| 427120S | Screw Holes: 20.0 Holes | In distribution |
| 627742 | Length 175.0 mm | In distribution |
| 608260S | Diameter: 6.0 Millimeter | In distribution |
| 627532S | Number of Screw Holes: 2.0 Holes | In distribution |
| 661432 | Diameter: 3.5 Millimeter | In distribution |
| 427007S | Length 97.0 mm | In distribution |
| 427074S | Screw Holes: 14.0 Holes | In distribution |
| 627340S | Length 199.0 mm | In distribution |
| 705070 | In distribution | |
| 371520 | Diameter: 4.0 Millimeter | In distribution |
| 427004 | Screw Holes: 4.0 Holes | In distribution |
| 627484 | Screw Holes: 4.0 Holes | In distribution |
| 661738S | Diameter: 4.5 Millimeter | In distribution |
| 661428 | Length 28.0 mm | In distribution |
| 627408 | Screw Holes: 8.0 Holes | In distribution |
| 437506 | Length 166.0 mm | In distribution |
| 371590 | Diameter: 4.0 Millimeter | In distribution |
| 661424 | Diameter: 3.5 Millimeter | In distribution |
| 627704S | Length 71.0 mm | In distribution |
| 608310 | Diameter: 6.0 Millimeter | In distribution |
| 437228 | Length 146.0 mm | In distribution |
| 427006S | Length 84.0 mm | In distribution |
| 661122S | Length 22.0 mm | In distribution |
| 627506 | Number of Screw Holes: 6.0 Holes | In distribution |
| 608320 | Diameter: 6.0 Millimeter | In distribution |
| 661040S | Length 40.0 mm | In distribution |
| 661040 | Diameter: 4.0 Millimeter | In distribution |
| 427065S | Screw Holes: 5.0 Holes | In distribution |
| 427174 | Screw Holes: 14.0 Holes | In distribution |
| 661042S | Diameter: 4.0 Millimeter | In distribution |
| 627566 | Length 119.0 mm | In distribution |
| 661470S | Diameter: 3.5 Millimeter | In distribution |
| 427136 | Screw Holes: 6.0 Holes | In distribution |
| 661815 | Diameter: 4.5 Millimeter | In distribution |
| 627516S | Number of Screw Holes: 16.0 Holes | In distribution |
| 436003 | Screw Holes: 3.0 Holes | In distribution |
| 661138S | Length 38.0 mm | In distribution |
| 627578S | Length 335.0 mm | In distribution |
| 427141S | Screw Holes: 11.0 Holes | In distribution |
| 427107S | Length 133.0 mm | In distribution |
| 661024S | Length 24.0 mm | In distribution |
| 661746S | Length 46.0 mm | In distribution |
| 427112 | Length 223.0 mm | In distribution |
| 427010 | Length 136.0 mm | In distribution |
| 437314 | Screw Holes: 14.0 Holes | In distribution |
| 627206S | Screw Holes: 6.0 Holes | In distribution |
| 661195S | Diameter: 5.0 Millimeter | In distribution |
| 627205S | Length 112.0 mm | In distribution |
| 661746 | Length 46.0 mm | In distribution |
| 371336 | Diameter: 5.0 Millimeter | In distribution |
| 627518S | Number of Screw Holes: 18.0 Holes | In distribution |
| 371385 | Diameter: 5.0 Millimeter | In distribution |
| 371026 | Diameter: 3.0 Millimeter | In distribution |
| 427066S | Screw Holes: 6.0 Holes | In distribution |
| 427176S | Length 254.0 mm | In distribution |
| 627204S | Screw Holes: 4.0 Holes | In distribution |
| 627612S | Screw Holes: 12.0 Holes | In distribution |
| 427040S | Screw Holes: 10.0 Holes | In distribution |
| 661460S | Length 60.0 mm | In distribution |
| 627414S | Length 227.0 mm | In distribution |
| 427139S | Screw Holes: 9.0 Holes | In distribution |
| 427039S | Screw Holes: 9.0 Holes | In distribution |
| 627344S | Screw Holes: 14.0 Holes | In distribution |
| 427046 | Length 192.0 mm | In distribution |
| 627608S | Screw Holes: 8.0 Holes | In distribution |
| 437310 | Screw Holes: 10.0 Holes | In distribution |
| 627454 | Length 102.0 mm | In distribution |
| 427148S | Screw Holes: 18.0 Holes | In distribution |
| 661114 | Length 14.0 mm | In distribution |
| 627504 | Number of Screw Holes: 4.0 Holes | In distribution |
| 661416 | Length 16.0 mm | In distribution |
| 627462 | Screw Holes: 12.0 Holes | In distribution |
| 627504S | Number of Screw Holes: 4.0 Holes | In distribution |
| 437214 | Screw Holes: 14.0 Holes | In distribution |
| 661080 | Length 80.0 mm | In distribution |
| 627612 | Length 274.0 mm | In distribution |
| 627540S | Number of Screw Holes: 10.0 Holes | In distribution |
| 627508S | Length 110.0 mm | In distribution |
| 661450S | Diameter: 3.5 Millimeter | In distribution |
| 437224 | Screw Holes: 4.0 Holes | In distribution |
| 627448S | Length 279.0 mm | In distribution |
| 427052 | Screw Holes: 22.0 Holes | In distribution |
| 627705S | Length 84.0 mm | In distribution |
| 661730S | Length 30.0 mm | In distribution |
| 437404 | Screw Holes: 4.0 Holes | In distribution |
| 427152S | Length 407.0 mm | In distribution |
| 661438 | Length 38.0 mm | In distribution |
| 661044 | Length 44.0 mm | In distribution |
| 661770 | Diameter: 4.5 Millimeter | In distribution |
| 661126 | Length 26.0 mm | In distribution |
| 661434S | Length 34.0 mm | In distribution |
| 661124 | Diameter: 5.0 Millimeter | In distribution |
| 627634S | Screw Holes: 4.0 Holes | In distribution |
| 661770S | Length 70.0 mm | In distribution |
| 627348S | Length 303.0 mm | In distribution |
| 627567S | Length 137.0 mm | In distribution |
| 427018 | Length 240.0 mm | In distribution |
| 661480 | Diameter: 3.5 Millimeter | In distribution |
| 661070 | Diameter: 4.0 Millimeter | In distribution |
| 436023 | Screw Holes: 3.0 Holes | In distribution |
| 437406 | Screw Holes: 6.0 Holes | In distribution |
| 661434 | Diameter: 3.5 Millimeter | In distribution |
| 627507 | Number of Screw Holes: 7.0 Holes | In distribution |
| 661118S | Diameter: 5.0 Millimeter | In distribution |
| 627616 | Length 343.0 mm | In distribution |
| 661014S | Diameter: 4.0 Millimeter | In distribution |
| 661060 | Diameter: 4.0 Millimeter | In distribution |
| 661065S | Diameter: 4.0 Millimeter | In distribution |
| 661810S | Diameter: 4.5 Millimeter | In distribution |
| 627546S | Number of Screw Holes: 16.0 Holes | In distribution |
| 627748S | Screw Holes: 18.0 Holes | In distribution |
| 661442 | Diameter: 3.5 Millimeter | In distribution |
| 627644 | Length 310.0 mm | In distribution |
| 627539S | Number of Screw Holes: 9.0 Holes | In distribution |
| 608295S | Diameter: 6.0 Millimeter | In distribution |
| 627436 | Length 123.0 mm | In distribution |
| 661744 | Length 44.0 mm | In distribution |
| 437136S | Screw Holes: 16.0 Holes | In distribution |
| 437232 | Screw Holes: 12.0 Holes | In distribution |
| 661038 | Length 38.0 mm | In distribution |
| 427140 | Screw Holes: 10.0 Holes | In distribution |
| 608270 | Diameter: 6.0 Millimeter | In distribution |
| 627334S | Screw Holes: 4.0 Holes | In distribution |
| 661830 | Length 130.0 mm | In distribution |
| 427036 | Screw Holes: 6.0 Holes | In distribution |
| 661510S | Diameter: 3.5 Millimeter | In distribution |
| 627240S | Length 176.0 mm | In distribution |
| 627322S | Length 355.0 mm | In distribution |
| 427066 | Length 76.0 mm | In distribution |
| 661118 | Diameter: 5.0 Millimeter | In distribution |
| 627436S | Screw Holes: 6.0 Holes | In distribution |
| 661742 | Length 42.0 mm | In distribution |
| 627505S | Length 71.0 mm | In distribution |
| 661444 | Diameter: 3.5 Millimeter | In distribution |
| 627510S | Number of Screw Holes: 10.0 Holes | In distribution |
| 661728S | Diameter: 4.5 Millimeter | In distribution |
| 627512S | Number of Screw Holes: 12.0 Holes | In distribution |
| 661134 | Length 34.0 mm | In distribution |
| 427063S | Length 37.0 mm | In distribution |
| 427170 | Screw Holes: 10.0 Holes | In distribution |
| 661128S | Diameter: 5.0 Millimeter | In distribution |
| 627456 | Screw Holes: 6.0 Holes | In distribution |
| 661732 | Length 32.0 mm | In distribution |
| 661736 | Diameter: 4.5 Millimeter | In distribution |
| 627716S | Length 227.0 mm | In distribution |
| 371542 | Diameter: 4.0 Millimeter | In distribution |
| 661465 | Length 65.0 mm | In distribution |
| 627460S | Screw Holes: 10.0 Holes | In distribution |
| 627338S | Length 173.0 mm | In distribution |
| 627706S | Screw Holes: 6.0 Holes | In distribution |
| 627574 | Number of Screw Holes: 14.0 Holes | In distribution |
| 627514 | Number of Screw Holes: 14.0 Holes | In distribution |
| 661136 | Diameter: 5.0 Millimeter | In distribution |
| 705069 | In distribution | |
| 627346S | Screw Holes: 16.0 Holes | In distribution |
| 661148 | Length 48.0 mm | In distribution |
| 608240 | Diameter: 6.0 Millimeter | In distribution |
| 661830S | Diameter: 4.5 Millimeter | In distribution |
| 627233S | Screw Holes: 3.0 Holes | In distribution |
| 661170 | Length 70.0 mm | In distribution |
| 705065 | In distribution | |
| 627714S | Screw Holes: 14.0 Holes | In distribution |
| 627332S | Length 95.0 mm | In distribution |
| 627235S | Screw Holes: 5.0 Holes | In distribution |
| 627490S | Length 178.0 mm | In distribution |
| 661195 | Diameter: 5.0 Millimeter | In distribution |
| 627438S | Length 149.0 mm | In distribution |
| 661150S | Diameter: 5.0 Millimeter | In distribution |
| 427118 | Screw Holes: 18.0 Holes | In distribution |
| 661718S | Length 18.0 mm | In distribution |
| 371014 | Diameter: 3.0 Millimeter | In distribution |
| 661835S | Diameter: 4.5 Millimeter | In distribution |
| 437520S | Screw Holes: 20.0 Holes | In distribution |
| 608350 | Diameter: 6.0 Millimeter | In distribution |
| 427122 | Length 403.0 mm | In distribution |
| 427108 | Screw Holes: 8.0 Holes | In distribution |
| 661470 | Length 70.0 mm | In distribution |
| 661740 | Diameter: 4.5 Millimeter | In distribution |
| 627542S | Length 223.0 mm | In distribution |
| 627610S | Length 238.0 mm | In distribution |
| 437103 | Screw Holes: 3.0 Holes | In distribution |
| 661455 | Diameter: 3.5 Millimeter | In distribution |
| 371370 | Length 70.0 mm | In distribution |
| 627520S | Length 266.0 mm | In distribution |
| 371022 | Length 22.0 mm | In distribution |
| 427034S | Screw Holes: 4.0 Holes | In distribution |
| 437534 | Length 310.0 mm | In distribution |
| 627544S | Length 259.0 mm | In distribution |
| 661475 | Diameter: 3.5 Millimeter | In distribution |
| 371522 | Length 22.0 mm | In distribution |
| 627638 | Screw Holes: 8.0 Holes | In distribution |
| 661420 | Diameter: 3.5 Millimeter | In distribution |
| 427016S | Length 214.0 mm | In distribution |
| 427120 | Screw Holes: 20.0 Holes | In distribution |
| 627242S | Screw Holes: 12.0 Holes | In distribution |
| 427103 | Length 61.0 mm | In distribution |
| 371348 | Length 48.0 mm | In distribution |
| 427010S | Screw Holes: 10.0 Holes | In distribution |
| 437140S | Screw Holes: 20.0 Holes | In distribution |
| 427020S | Screw Holes: 20.0 Holes | In distribution |
| 661314S | Diameter: 5.0 Millimeter | In distribution |
| 627738S | Length 123.0 mm | In distribution |
| 661730 | Diameter: 4.5 Millimeter | In distribution |
| 627414 | Screw Holes: 14.0 Holes | In distribution |
| 371016 | Diameter: 3.0 Millimeter | In distribution |
| 437424 | Screw Holes: 4.0 Holes | In distribution |
| 437318S | Screw Holes: 18.0 Holes | In distribution |
| 427005S | Length 71.0 mm | In distribution |
| 627203S | Length 86.0 mm | In distribution |
Showing 250 of 300 catalogue numbers.
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 Naming This Product
2 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 |
|---|---|---|---|---|---|---|---|
| Howmedica Osteonics Corp | 510(k) number | 2008-11-24 | Not classified | Other | Potential Breakage: Stryker Orthopaedics became aware that there is the potential for the tip of the AxSOS Screwdriver and the AxSOS Torque Limiter to break. | 467 units | 2010-04-06 |
| Howmedica Osteonics Corp | 510(k) number | 2008-11-24 | Not classified | Other | Potential Breakage: Stryker Orthopaedics became aware that there is the potential for the tip of the AxSOS Screwdriver and the AxSOS Torque Limiter to break. | 415 units | 2010-04-06 |
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.