Triway
Triway Headed Cotter Screw 5.0 MM Titanium Sterile LG 30 MM
31manufacturers in China registered for this device type
25catalogue numbers in this listing
6510(k) clearances naming this product code
5recalls 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 | In2Bones SAS, France |
|---|---|
| FDA product code | HWC |
| Device type | Screw, Fixation, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3040 |
| Establishment | Specification developer, Manufacturer, Exporter |
| 510(k) | K173811 |
| Record published | 2019-03-06 |
| Record revised | 2025-12-15 (version 9) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Sizes | Length 25 to 110 mm; outer diameter 5 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| N20 ST550 | Length 50 mm | In distribution |
| N20 ST575 | Outer Diameter 5 mm | In distribution |
| N20 ST525 | Length 25 mm | In distribution |
| N20 ST530 | Length 25 mm | In distribution |
| N20 ST730 | In distribution | |
| N20 ST535 | Outer Diameter 5 mm | In distribution |
| N20 ST555 | Outer Diameter 5 mm | In distribution |
| N20 ST722 | In distribution | |
| N20 ST610 | Length 110 mm | In distribution |
| N20 ST545 | Outer Diameter 5 mm | In distribution |
| N20 ST540 | Length 40 mm | In distribution |
| N20 ST600 | Length 100 mm | In distribution |
| N20 ST560 | Length 60 mm | In distribution |
| N20 ST732 | In distribution | |
| N20 ST727 | In distribution | |
| N20 ST570 | Length 70 mm | In distribution |
| N20 ST565 | Outer Diameter 5 mm | In distribution |
| N20 ST735 | In distribution | |
| N20 ST725 | In distribution | |
| N20 ST605 | Outer Diameter 5 mm | In distribution |
| N20 ST585 | Outer Diameter 5 mm | In distribution |
| N20 ST580 | Length 80 mm | In distribution |
| N20 ST720 | In distribution | |
| N20 ST590 | Length 90 mm | In distribution |
| N20 ST595 | Outer Diameter 5 mm | In distribution |
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 |
|---|---|
| K170688 | 2017-11-28 |
| K170594 | 2017-05-10 |
| K160174 | 2016-10-06 |
| K132912 | 2014-07-30 |
| K131920 | 2014-05-01 |
| K132911 | 2014-04-04 |
Recalls
5 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 |
|---|---|---|---|---|---|
| 2024-01-26 | Class II | Process control | This Field Action is being conducted following the identification of a batch mix-up between I.B.S Compression screws diameter 6.5mm length 75mm and I.B.S Compression screws diameter 6.5mm length 80mm. The screws of the batches concerned by | 63 units | |
| 2024-01-26 | Class II | Process control | This Field Action is being conducted following the identification of a batch mix-up between I.B.S Compression screws diameter 6.5mm length 75mm and I.B.S Compression screws diameter 6.5mm length 80mm. The screws of the batches concerned by | 59 units | |
| 2015-11-18 | Class II | Nonconforming Material/Component | One batch of osteosynthesis screws were manufactured with the incorrect Torx imprint on the screw head. | 20 units | 2016-08-19 |
| 2015-03-09 | Class II | Nonconforming Material/Component | Dimensional non-conformity leading to the impossibility to introduce the implant in the dedicated holder. | 35 units | 2016-05-19 |
| 2015-03-09 | Class II | Nonconforming Material/Component | Dimensional non-conformity leading to the impossibility to introduce the implant in the dedicated holder. | 15 units | 2016-05-19 |
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.