DuaFit®
Interphalangeal implants
31manufacturers in China registered for this device type
12catalogue 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) | K132912 |
| Record published | 2019-11-04 |
| Record revised | 2025-12-15 (version 4) |
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 | Angle 0 to 17 °; length 11 to 20 mm |
| Distribution end date | 2024-12-23 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| A60 SP171 B | Angle 17 ° | Withdrawn |
| A60 SP174 B | Angle 17 ° | Withdrawn |
| A60 SP001 B | Angle 0 ° | Withdrawn |
| A60 SP102 B | Angle 10 ° | Withdrawn |
| A60 SP004 B | Length 20 mm | Withdrawn |
| A60 SP101 B | Angle 10 ° | Withdrawn |
| A60 SP003 B | Angle 0 ° | Withdrawn |
| A60 SP002 B | Length 14 mm | Withdrawn |
| A60 SP172 B | Angle 17 ° | Withdrawn |
| A60 SP173 B | Angle 17 ° | Withdrawn |
| A60 SP104 B | Angle 10 ° | Withdrawn |
| A60 SP103 B | Angle 10 ° | 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
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 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 |
|---|---|---|---|---|---|---|---|
| In2Bones SAS | 510(k) number | 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 |
| In2Bones SAS | 510(k) number | 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 |
Recalls
3 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 |
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.