Biofoam
Midfoot Trial
31manufacturers in China registered for this device type
38catalogue numbers in this listing
2510(k) clearances naming this product code
8recalls 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 | Wright Medical Technology, Inc., United States |
|---|---|
| FDA product code | HWC |
| Device type | Screw, Fixation, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3040 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2016-09-17 |
| Record revised | 2022-05-17 (version 6) |
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, manufacturing date |
| Sizes | Height 4.5 to 12 mm; length 16 to 20 mm; width 20 mm |
| Distribution end date | 2016-03-14 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 47S02095 | Size: 20mm x 16mm x 9.5mm | In distribution |
| 46S01515 | Size: 15mm | In distribution |
| 47S02045 | Size: 20mm x 14mm x 4.5mm | In distribution |
| 47S52010 | Size: 20mm x 20mm x 10mm | In distribution |
| 47S01309 | Size: 13mm x 17mm x 9mm | In distribution |
| 46607522 | Size: 14 x 10 x 22 x 7.5 x 2.5mm | In distribution |
| 46S01520 | Size: 20mm | In distribution |
| 47S01645 | Size: 16mm x 14mm x 4.5mm | In distribution |
| 47S52008 | Size: 20mm x 20mm x 8mm | In distribution |
| 46S42010 | Width 20 mm | In distribution |
| 46S52210 | Size: 22 x 22mm | In distribution |
| 47S02075 | Size: 20mm x 16mm x 7.5mm | In distribution |
| 47S01665 | Size: 16mm x 14mm x 6.5mm | In distribution |
| 47S51810 | Size: 18mm x 18mm x 10mm | In distribution |
| 47S51812 | Size: 18mm x 18mm x 12mm | In distribution |
| 46S01665 | Length 16 mm | In distribution |
| 46S01309 | Height 9 mm | In distribution |
| 47S02055 | Size: 20mm x 14mm x 5.5mm | In distribution |
| 46S52012 | Size: 20 x 20mm | In distribution |
| 47S52012 | Size: 20mm x 20mm x 12mm | In distribution |
| 47S02065 | Size: 20mm x 14mm x 6.5mm | In distribution |
| 46S02065 | Length 20 mm | In distribution |
| 46S02085 | Length 20 mm | In distribution |
| 47S52212 | Size: 22mm x 22mm x 12mm | In distribution |
| 46S01310 | Length 17 mm | In distribution |
| 46S01308 | Length 17 mm | In distribution |
| 46S52208 | Size: 22 x 22mm | In distribution |
| 46S52008 | Height 8 mm | In distribution |
| 47S01655 | Size: 16mm x 14mm x 5.5mm | In distribution |
| 46641022 | Size: 22 x 20 x 10mm | In distribution |
| 46S42012 | Height 12 mm | In distribution |
| 46S02075 | Height 7.5 mm | In distribution |
| 46S51808 | Size: 18 x 18mm | In distribution |
| 46S01312 | Height 12 mm | In distribution |
| 46001308 | Size: 8mm | In distribution |
| 46S52212 | Size: 22 x 22mm | In distribution |
| 46S02045 | Length 20 mm | In distribution |
| 46S42008 | Length 20 mm | 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 |
|---|---|
| K221645 | 2023-02-17 |
| K203228 | 2021-05-11 |
Recalls
6 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 |
|---|---|---|---|---|---|
| 2016-11-08 | Class II | Process control | The firm discovered a lack of adequate documentation confirming sterility on certain products. | 40 units | 2020-11-03 |
| 2016-11-08 | Class II | Process control | The firm discovered a lack of adequate documentation confirming sterility on certain products. | 77 units | 2020-11-03 |
| 2015-04-16 | Class II | Process control | The term DORSAL was laser etched on the incorrect side on some of the angled handles. | 121 units | 2018-10-18 |
| 2015-04-16 | Class II | Process control | The term DORSAL was laser etched on the incorrect side on some of the angled handles. | 126 units | 2018-10-18 |
| 2015-04-16 | Class II | Process control | The term DORSAL was laser etched on the incorrect side on some of the angled handles. | 126 units | 2018-10-18 |
| 2015-04-16 | Class II | Process control | The term DORSAL was laser etched on the incorrect side on some of the angled handles. | 124 units | 2018-10-18 |
| 2011-04-20 | Not classified | Process control | Two lots- one lot of Endo-Fuse Fusion Rod, 7x50mm was commingled one lot of Endo-Fuse(R) Fusion Rod, 7x70mm. Not all parts in each lot are affected. The commingled rod sizes might not be detected prior to surgery. | 65 | 2012-12-27 |
| 2011-04-20 | Not classified | Process control | Two lots- one lot of Endo-Fuse Fusion Rod, 7x50mm was commingled one lot of Endo-Fuse(R) Fusion Rod, 7x70mm. Not all parts in each lot are affected. The commingled rod sizes might not be detected prior to surgery. | 121 | 2012-12-27 |
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.