OrthoSolutions ‘System26’ Bone Screws
5.0MM X 38MM Headless Cannulated Screw Partially Threaded
31manufacturers in China registered for this device type
511catalogue numbers in this listing
1510(k) clearance
2recalls on this code
Who Else Makes It
Concentrated in Jiangsu (15), Shanghai (5), Zhejiang (3). 19 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| B-ONE Medical (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Suzhou Ahno Medical Devices Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 17 |
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Sanbor Medical Xiamen, Inc. | Xiamen | Fujian | Contract manufacturer | 16 |
| Suzhou Kangli Orthopaedics Instrument Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 11 |
Showing 12 of 31. All 31 manufacturers in China registered for Screw, Fixation, Bone
Record
| Listed by | Ortho Solutions Inc, United States |
|---|---|
| FDA product code | HWC |
| Device type | Screw, Fixation, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3040 |
| Establishment | Complaint-file establishment |
| 510(k) | K163489 |
| Record published | 2017-03-20 |
| Record revised | 2025-11-20 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Label carries | lot or batch number |
| Distribution end date | 2019-02-12 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| OS912038-NS | In distribution | |
| OS904018-NS | In distribution | |
| OS918120-NS | In distribution | |
| OS903022-NS | In distribution | |
| OS914070-NS | In distribution | |
| OS903026-NS | In distribution | |
| OS909026-NS | In distribution | |
| OS923070-NS | In distribution | |
| OS921060-NS | In distribution | |
| OS912040-NS | In distribution | |
| OS920090-NS | In distribution | |
| OS919060-NS | In distribution | |
| OS908040-NS | In distribution | |
| OS902010-NS | In distribution | |
| OS915080-NS | In distribution | |
| OS310014-NS | In distribution | |
| OS907018-NS | In distribution | |
| OS913120-NS | In distribution | |
| OS912075-NS | In distribution | |
| OS918050-NS | In distribution | |
| OS911055-NS | In distribution | |
| OS916035-NS | In distribution | |
| OS916115-NS | In distribution | |
| OS922075-NS | In distribution | |
| OS913095-NS | In distribution | |
| OS920070-NS | In distribution | |
| OS922095-NS | In distribution | |
| OS914090-NS | In distribution | |
| OS907036-NS | In distribution | |
| OS922100-NS | In distribution | |
| OS913035-NS | In distribution | |
| OS915095-NS | In distribution | |
| OS903012-NS | In distribution | |
| OS917070-NS | In distribution | |
| OS905012-NS | In distribution | |
| OS310018-NS | In distribution | |
| OS913090-NS | In distribution | |
| OS904012-NS | In distribution | |
| OS919070-NS | In distribution | |
| OS909010-NS | In distribution | |
| OS908026-NS | In distribution | |
| OS904020-NS | In distribution | |
| OS908020-NS | In distribution | |
| OS921095-NS | In distribution | |
| OS909036-NS | In distribution | |
| OS924105-NS | In distribution | |
| OS908016-NS | In distribution | |
| OS924080-NS | In distribution | |
| OS911090-NS | In distribution | |
| OS921070-NS | In distribution | |
| OS904024-NS | In distribution | |
| OS909028-NS | In distribution | |
| OS910018-NS | In distribution | |
| OS910026-NS | In distribution | |
| OS919035-NS | In distribution | |
| OS909024-NS | In distribution | |
| OS923085-NS | In distribution | |
| OS911075-NS | In distribution | |
| OS911040-NS | In distribution | |
| OS923110-NS | In distribution | |
| OS914050-NS | In distribution | |
| OS922070-NS | In distribution | |
| OS903018-NS | In distribution | |
| OS922115-NS | In distribution | |
| OS903014-NS | In distribution | |
| OS912090-NS | In distribution | |
| OS907016-NS | In distribution | |
| OS906016-NS | In distribution | |
| OS910042-NS | In distribution | |
| OS920110-NS | In distribution | |
| OS917080-NS | In distribution | |
| OS903016-NS | In distribution | |
| OS915065-NS | In distribution | |
| OS918075-NS | In distribution | |
| OS911046-NS | In distribution | |
| OS912046-NS | In distribution | |
| OS911044-NS | In distribution | |
| OS915105-NS | In distribution | |
| OS914120-NS | In distribution | |
| OS922085-NS | In distribution | |
| OS912034-NS | In distribution | |
| OS911030-NS | In distribution | |
| OS923080-NS | In distribution | |
| OS916100-NS | In distribution | |
| OS919095-NS | In distribution | |
| OS908032-NS | In distribution | |
| OS910048-NS | In distribution | |
| OS910046-NS | In distribution | |
| OS914045-NS | In distribution | |
| OS914105-NS | In distribution | |
| OS918080-NS | In distribution | |
| OS905016-NS | In distribution | |
| OS903030-NS | In distribution | |
| OS909042-NS | In distribution | |
| OS920080-NS | In distribution | |
| OS918100-NS | In distribution | |
| OS904028-NS | In distribution | |
| OS917110-NS | In distribution | |
| OS911050-NS | In distribution | |
| OS909050-NS | In distribution | |
| OS922110-NS | In distribution | |
| OS911080-NS | In distribution | |
| OS901010-NS | In distribution | |
| OS907040-NS | In distribution | |
| OS915120-NS | In distribution | |
| OS916045-NS | In distribution | |
| OS912065-NS | In distribution | |
| OS917100-NS | In distribution | |
| OS918090-NS | In distribution | |
| OS901014-NS | In distribution | |
| OS906018-NS | In distribution | |
| OS923055-NS | In distribution | |
| OS923105-NS | In distribution | |
| OS909048-NS | In distribution | |
| OS919100-NS | In distribution | |
| OS921110-NS | In distribution | |
| OS916085-NS | In distribution | |
| OS917055-NS | In distribution | |
| OS910022-NS | In distribution | |
| OS921075-NS | In distribution | |
| OS922080-NS | In distribution | |
| OS920065-NS | In distribution | |
| OS914065-NS | In distribution | |
| OS924085-NS | In distribution | |
| OS919065-NS | In distribution | |
| OS919090-NS | In distribution | |
| OS921085-NS | In distribution | |
| OS910036-NS | In distribution | |
| OS919055-NS | In distribution | |
| OS921080-NS | In distribution | |
| OS923050-NS | In distribution | |
| OS913070-NS | In distribution | |
| OS908028-NS | In distribution | |
| OS917115-NS | In distribution | |
| OS914115-NS | In distribution | |
| OS920095-NS | In distribution | |
| OS909012-NS | In distribution | |
| OS916060-NS | In distribution | |
| OS923095-NS | In distribution | |
| OS907038-NS | In distribution | |
| OS917075-NS | In distribution | |
| OS910040-NS | In distribution | |
| OS911070-NS | In distribution | |
| OS916050-NS | In distribution | |
| OS920085-NS | In distribution | |
| OS921115-NS | In distribution | |
| OS904026-NS | In distribution | |
| OS910030-NS | In distribution | |
| OS917105-NS | In distribution | |
| OS905024-NS | In distribution | |
| OS910050-NS | In distribution | |
| OS915090-NS | In distribution | |
| OS918085-NS | In distribution | |
| OS912070-NS | In distribution | |
| OS916120-NS | In distribution | |
| OS920050-NS | In distribution | |
| OS919120-NS | In distribution | |
| OS310013-NS | In distribution | |
| OS310012-NS | In distribution | |
| OS912032-NS | In distribution | |
| OS918055-NS | In distribution | |
| OS904010-NS | In distribution | |
| OS908022-NS | In distribution | |
| OS907022-NS | In distribution | |
| OS922090-NS | In distribution | |
| OS922050-NS | In distribution | |
| OS912044-NS | In distribution | |
| OS909055-NS | In distribution | |
| OS905030-NS | In distribution | |
| OS909030-NS | In distribution | |
| OS913105-NS | In distribution | |
| OS902014-NS | In distribution | |
| OS914055-NS | In distribution | |
| OS905022-NS | In distribution | |
| OS918070-NS | In distribution | |
| OS916105-NS | In distribution | |
| OS912036-NS | In distribution | |
| OS919080-NS | In distribution | |
| OS903020-NS | In distribution | |
| OS906014-NS | In distribution | |
| OS907032-NS | In distribution | |
| OS910060-NS | In distribution | |
| OS924050-NS | In distribution | |
| OS904016-NS | In distribution | |
| OS908018-NS | In distribution | |
| OS919040-NS | In distribution | |
| OS920120-NS | In distribution | |
| OS916075-NS | In distribution | |
| OS909060-NS | In distribution | |
| OS922065-NS | In distribution | |
| OS907012-NS | In distribution | |
| OS918115-NS | In distribution | |
| OS910070-NS | In distribution | |
| OS913080-NS | In distribution | |
| OS912048-NS | In distribution | |
| OS922105-NS | In distribution | |
| OS919045-NS | In distribution | |
| OS908030-NS | In distribution | |
| OS916080-NS | In distribution | |
| OS922120-NS | In distribution | |
| OS924075-NS | In distribution | |
| OS916055-NS | In distribution | |
| OS909020-NS | In distribution | |
| OS910016-NS | In distribution | |
| OS902016-NS | In distribution | |
| OS922040-NS | In distribution | |
| OS924100-NS | In distribution | |
| OS920045-NS | In distribution | |
| OS909034-NS | In distribution | |
| OS906022-NS | In distribution | |
| OS908014-NS | In distribution | |
| OS918045-NS | In distribution | |
| OS909065-NS | In distribution | |
| OS914110-NS | In distribution | |
| OS918110-NS | In distribution | |
| OS924055-NS | In distribution | |
| OS910044-NS | In distribution | |
| OS923075-NS | In distribution | |
| OS914080-NS | In distribution | |
| OS921065-NS | In distribution | |
| OS920100-NS | In distribution | |
| OS310015-NS | In distribution | |
| OS910020-NS | In distribution | |
| OS913100-NS | In distribution | |
| OS924090-NS | In distribution | |
| OS923060-NS | In distribution | |
| OS923115-NS | In distribution | |
| OS911065-NS | In distribution | |
| OS911060-NS | In distribution | |
| OS914085-NS | In distribution | |
| OS310016-NS | In distribution | |
| OS924095-NS | In distribution | |
| OS906028-NS | In distribution | |
| OS920060-NS | In distribution | |
| OS920115-NS | In distribution | |
| OS920055-NS | In distribution | |
| OS905014-NS | In distribution | |
| OS908038-NS | In distribution | |
| OS909070-NS | In distribution | |
| OS917085-NS | In distribution | |
| OS902012-NS | In distribution | |
| OS913040-NS | In distribution | |
| OS920075-NS | In distribution | |
| OS915115-NS | In distribution | |
| OS916070-NS | In distribution | |
| OS915110-NS | In distribution | |
| OS909044-NS | In distribution | |
| OS908024-NS | In distribution | |
| OS913055-NS | In distribution | |
| OS913075-NS | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Screw, Fixation, Bone | Synthes Gmbh | 3,975 |
| Aptus | Medartis Inc. | 3,623 |
| Acumed | Acumed LLC | 3,187 |
| Arthrex® | Arthrex, Inc. | 2,781 |
| OsteoMed | Osteomed | 2,764 |
| Screw, Fixation, Bone | AAP Implantate AG | 2,176 |
| Screw, Fixation, Bone | Zimmer, Inc. | 1,993 |
| Arix System Bone Screw | Jeil Medical Corporation | 1,875 |
| Cannulated Screw System + | Tyber Medical | 1,814 |
| Cannulated Compression Headless Screw | Tyber Medical | 1,621 |
| Microware Bone Plates and Bone Screws | Microware Precision Co., Ltd. | 1,601 |
| Anthem | Globus Medical, Inc. | 1,538 |
Showing 12 of 5,775. All products under Screw, Fixation, Bone
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K110895 | 2011-12-19 |
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 |
|---|---|---|---|---|---|---|---|
| Ortho Solutions UK Limited | 510(k) number | 2017-10-10 | Class II | Process control | Following the identification of corrosion residue found inside the cannulated devices in Forefoot and Midfoot trays Orhto Solutions Group has taken the decision to recall ALL x106 System 26 Forefoot and Midfoot Implants and Instruments tray | 120 | 2018-08-31 |
Recalls
2 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 |
|---|---|---|---|---|---|
| 2016-07-21 | Class II | Labeling mix-ups | Mislabeling of a single batch of FPS 3.5 x 35 mm Locking Screw as being Non-Locking Screws. | 15 | 2016-10-12 |
| 2015-07-14 | Class II | Nonconforming Material/Component | Ortho Solutions Inc is initiating a recall on behalf of UltOS 3.5mm locking screw. The locking thread feature of the screw was not manufactured to specification. As a consequence there is a risk that a screw may not lock onto the plate at | 875 units | 2017-04-26 |
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.