Cortical Screw
Cortical Screw, D=4.5mm, L=28mm, metric Thread
31manufacturers in China registered for this device type
151catalogue numbers in this listing
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 | I.T.S. Gmbh, Austria |
|---|---|
| FDA product code | HWC |
| Device type | Screw, Fixation, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3040 |
| Establishment | Complaint-file establishment, Manufacturer |
| 510(k) | K063166 |
| Record published | 2016-09-01 |
| Record revised | 2026-06-19 (version 8) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Distribution end date | 2024-08-06 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 32351-42 | In distribution | |
| 32455-60 | In distribution | |
| 32455-44 | In distribution | |
| 32271-20 | In distribution | |
| 32351-40 | In distribution | |
| 32455-28 | In distribution | |
| 32271-24 | In distribution | |
| 32151-7 | In distribution | |
| 32455-52 | In distribution | |
| 32151-16 | In distribution | |
| 32271-14 | In distribution | |
| 32351-70 | In distribution | |
| 32351-24 | In distribution | |
| 32271-50 | In distribution | |
| 32455-65 | In distribution | |
| 32351-12 | In distribution | |
| 32271-42 | In distribution | |
| 32351-65 | In distribution | |
| 32271-44 | In distribution | |
| 32271-16 | In distribution | |
| 32475-48 | In distribution | |
| 32271-15 | In distribution | |
| 32652-68 | In distribution | |
| 32475-80 | In distribution | |
| 32652-110 | In distribution | |
| 32271-10 | In distribution | |
| 32455-100 | In distribution | |
| 32455-105 | In distribution | |
| 32271-30 | In distribution | |
| 32652-88 | In distribution | |
| 32151-24 | In distribution | |
| 32271-48 | In distribution | |
| 32455-24 | In distribution | |
| 32271-8 | In distribution | |
| 32351-28 | In distribution | |
| 32451-28 | In distribution | |
| 32652-120 | In distribution | |
| 32351-26 | In distribution | |
| 32271-6 | In distribution | |
| 32351-105 | In distribution | |
| 32652-72 | In distribution | |
| 32271-55 | In distribution | |
| 32652-64 | In distribution | |
| 32451-40 | In distribution | |
| 32455-32 | In distribution | |
| 32475-70 | In distribution | |
| 32351-75 | In distribution | |
| 32455-40 | In distribution | |
| 32451-24 | In distribution | |
| 32271-9 | In distribution | |
| 32351-120 | In distribution | |
| 32351-44 | In distribution | |
| 32151-8 | In distribution | |
| 32652-40 | In distribution | |
| 32151-11 | In distribution | |
| 32271-26 | In distribution | |
| 32652-96 | In distribution | |
| 32652-44 | In distribution | |
| 32351-22 | In distribution | |
| 32271-28 | In distribution | |
| 32151-9 | In distribution | |
| 32351-30 | In distribution | |
| 32652-56 | In distribution | |
| 32652-52 | In distribution | |
| 32455-110 | In distribution | |
| 32271-32 | In distribution | |
| 32455-20 | In distribution | |
| 32271-40 | In distribution | |
| 32271-18 | In distribution | |
| 32455-56 | In distribution | |
| 32475-44 | In distribution | |
| 32652-100 | In distribution | |
| 32475-52 | In distribution | |
| 32151-26 | In distribution | |
| 32475-30 | In distribution | |
| 32151-22 | In distribution | |
| 32271-22 | In distribution | |
| 32351-18 | In distribution | |
| 32351-38 | In distribution | |
| 32475-40 | In distribution | |
| 32271-13 | In distribution | |
| 32455-115 | In distribution | |
| 32455-16 | In distribution | |
| 32351-14 | In distribution | |
| 32351-95 | In distribution | |
| 32271-46 | In distribution | |
| 32652-76 | In distribution | |
| 32151-14 | In distribution | |
| 32652-92 | In distribution | |
| 32475-32 | In distribution | |
| 32151-18 | In distribution | |
| 32271-36 | In distribution | |
| 32151-13 | In distribution | |
| 32455-36 | In distribution | |
| 32451-44 | In distribution | |
| 32271-34 | In distribution | |
| 32351-48 | In distribution | |
| 32652-84 | In distribution | |
| 32652-115 | In distribution | |
| 32351-110 | In distribution | |
| 32451-50 | In distribution | |
| 32652-60 | In distribution | |
| 32451-32 | In distribution | |
| 32652-48 | In distribution | |
| 32455-95 | In distribution | |
| 32455-85 | In distribution | |
| 32475-56 | In distribution | |
| 32351-34 | In distribution | |
| 32475-60 | In distribution | |
| 32455-120 | In distribution | |
| 32451-48 | In distribution | |
| 32351-90 | In distribution | |
| 32351-115 | In distribution | |
| 32455-70 | In distribution | |
| 32475-34 | In distribution | |
| 32652-80 | In distribution | |
| 32351-85 | In distribution | |
| 32351-32 | In distribution | |
| 32271-12 | In distribution | |
| 32351-55 | In distribution | |
| 32151-12 | In distribution | |
| 32475-36 | In distribution | |
| 32475-38 | In distribution | |
| 32271-38 | In distribution | |
| 32151-6 | In distribution | |
| 32351-16 | In distribution | |
| 32151-5 | In distribution | |
| 32351-100 | In distribution | |
| 32455-48 | In distribution | |
| 32151-10 | In distribution | |
| 32351-36 | In distribution | |
| 32451-38 | In distribution | |
| 32451-36 | In distribution | |
| 32455-75 | In distribution | |
| 32475-42 | In distribution | |
| 32475-28 | In distribution | |
| 32151-20 | In distribution | |
| 32151-15 | In distribution | |
| 32455-90 | In distribution | |
| 32271-7 | In distribution | |
| 32351-20 | In distribution | |
| 32351-50 | In distribution | |
| 32455-80 | In distribution | |
| 32475-75 | In distribution | |
| 32351-10 | In distribution | |
| 32351-80 | In distribution | |
| 32351-46 | In distribution | |
| 32652-105 | In distribution | |
| 32475-65 | In distribution | |
| 32351-60 | In distribution | |
| 32271-6 | Withdrawn |
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
Recalls
2 of these are Class II. Class II means a temporary or reversible health consequence. 2 are recorded with the root cause “No Marketing Application”: the device was distributed without the premarket submission its class requires, a compliance finding rather than a defect. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2026-01-23 | Class II | No Marketing Application | Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU). | 5,568 units |
| 2026-01-23 | Class II | No Marketing Application | Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU). | 623 units |
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.