PROstep MIS
PROstep MIS 5 mm Chamfer Screw is a titanium-alloy fixation screw for bone fractures and reconstruction. Its uses include minimally invasive correction of hallux valgus with subsequent…
PROstep MIS 5 mm Chamfer Screw is a titanium-alloy fixation screw for bone fractures and reconstruction. Its uses include minimally invasive correction of hallux valgus with subsequent first metatarsal-cuneiform fusion.
The cannulated screw is fully threaded, with self-tapping features on both distal and proximal threads. A 30-degree chamfered head is part of the screw design.
Listed Item
Chamfer Screw
Length and Supply Options
The screw range has multiple lengths to accommodate anatomy. Implants are supplied sterile, while associated instruments are available in sterile and nonsterile formats. The selected screw is an internal fixation component within the foot-reconstruction system.
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 |
| 510(k) | K221645 |
| Record published | 2023-07-27 |
| Record revised | 2024-02-19 (version 2) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Sizes | Outer diameter 5 mm; length 30 to 80 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 57S05048 | Outer Diameter 5 mm | In distribution |
| 57S05042 | Length 42 mm | In distribution |
| 57S05060 | Outer Diameter 5 mm | In distribution |
| 57S05030 | Length 30 mm | In distribution |
| 57S05056 | Outer Diameter 5 mm | In distribution |
| 57S05040 | Outer Diameter 5 mm | In distribution |
| 57S05054 | Length 54 mm | In distribution |
| 57S05032 | Outer Diameter 5 mm | In distribution |
| 57S05080 | Outer Diameter 5 mm | In distribution |
| 57S05075 | Outer Diameter 5 mm | In distribution |
| 57S05052 | 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 |
|---|---|
| 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.