IBS-B MIS
IBS-B MIS Fully Threaded Screw, Ø4.0x22mm
31manufacturers in China registered for this device type
88catalogue numbers in this listing
3510(k) clearances naming this product code
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 | IN2BONES USA, LLC, United States |
|---|---|
| FDA product code | HWC |
| Device type | Screw, Fixation, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3040 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Record published | 2026-01-24 |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| S41 ST822 | 22mm | In distribution |
| S34 ST758 | Ø3.3 | In distribution |
| S34 ST854 | Ø3.3 | In distribution |
| S34 ST822 | 22mm | In distribution |
| S41 ST734 | Ø4.0 | In distribution |
| S41 ST842 | 42mm | In distribution |
| S41 ST840 | 40mm | In distribution |
| S41 ST856 | Ø4.0 | In distribution |
| S34 ST828 | 28mm | In distribution |
| S41 ST838 | Ø4.0 | In distribution |
| S41 ST728 | 28mm | In distribution |
| S34 ST742 | Ø3.3 | In distribution |
| S34 ST856 | 56mm | In distribution |
| S34 ST736 | Ø3.3 | In distribution |
| S34 ST732 | 32mm | In distribution |
| S41 ST748 | Ø4.0 | In distribution |
| S34 ST818 | Ø3.3 | In distribution |
| S34 ST816 | 16mm | In distribution |
| S41 ST726 | Ø4.0 | In distribution |
| S34 ST716 | 16mm | In distribution |
| S41 ST826 | Ø4.0 | In distribution |
| S34 ST852 | Ø3.3 | In distribution |
| S41 ST854 | Ø4.0 | In distribution |
| S34 ST824 | Ø3.3 | In distribution |
| S34 ST844 | 44mm | In distribution |
| S41 ST844 | 44mm | In distribution |
| S34 ST840 | 40mm | In distribution |
| S34 ST740 | 40mm | In distribution |
| S41 ST836 | Ø4.0 | In distribution |
| S41 ST752 | 52mm | In distribution |
| S41 ST828 | Ø4.0 | In distribution |
| S41 ST848 | Ø4.0 | In distribution |
| S41 ST758 | Ø4.0 | In distribution |
| S34 ST746 | 46mm | In distribution |
| S34 ST838 | Ø3.3 | In distribution |
| S41 ST820 | 20mm | In distribution |
| S41 ST722 | Ø4.0 | In distribution |
| S41 ST830 | 30mm | In distribution |
| S34 ST748 | Ø3.3 | In distribution |
| S41 ST858 | Ø4.0 | In distribution |
| S34 ST850 | Ø3.3 | In distribution |
| S41 ST740 | Ø4.0 | In distribution |
| S34 ST744 | Ø3.3 | In distribution |
| S41 ST850 | 50mm | In distribution |
| S34 ST738 | 38mm | In distribution |
| S34 ST752 | Ø3.3 | In distribution |
| S41 ST720 | Ø4.0 | In distribution |
| S41 ST738 | Ø4.0 | In distribution |
| S41 ST756 | Ø4.0 | In distribution |
| S34 ST724 | Ø3.3 | In distribution |
| S34 ST826 | Ø3.3 | In distribution |
| S34 ST756 | Ø3.3 | In distribution |
| S34 ST832 | Ø3.3 | In distribution |
| S34 ST760 | 60mm | In distribution |
| S34 ST730 | 30mm | In distribution |
| S34 ST842 | Ø3.3 | In distribution |
| S41 ST852 | 52mm | In distribution |
| S41 ST824 | Ø4.0 | In distribution |
| S34 ST830 | Ø3.3 | In distribution |
| S34 ST834 | Ø3.3 | In distribution |
| S34 ST750 | Ø3.3 | In distribution |
| S34 ST720 | Ø3.3 | In distribution |
| S34 ST718 | Ø3.3 | In distribution |
| S34 ST754 | 54mm | In distribution |
| S34 ST836 | 36mm | In distribution |
| S41 ST760 | Ø4.0 | In distribution |
| S41 ST736 | 36mm | In distribution |
| S34 ST726 | Ø3.3 | In distribution |
| S34 ST846 | 46mm | In distribution |
| S41 ST832 | Ø4.0 | In distribution |
| S41 ST742 | 42mm | In distribution |
| S41 ST754 | 54mm | In distribution |
| S41 ST724 | Ø4.0 | In distribution |
| S41 ST732 | Ø4.0 | In distribution |
| S41 ST730 | 30mm | In distribution |
| S34 ST734 | 34mm | In distribution |
| S34 ST848 | Ø3.3 | In distribution |
| S41 ST846 | 46mm | In distribution |
| S34 ST728 | Ø3.3 | In distribution |
| S41 ST744 | Ø4.0 | In distribution |
| S41 ST750 | 50mm | In distribution |
| S41 ST746 | Ø4.0 | In distribution |
| S41 ST834 | Ø4.0 | In distribution |
| S41 ST860 | Ø4.0 | In distribution |
| S34 ST820 | 20mm | In distribution |
| S34 ST858 | Ø3.3 | In distribution |
| S34 ST860 | 60mm | In distribution |
| S34 ST722 | Ø3.3 | 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 |
|---|---|
| K261154 | 2026-05-30 |
| K231236 | 2023-07-27 |
| K180377 | 2018-06-20 |
Recalls
2 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 |
|---|---|---|---|---|---|
| 2018-07-16 | Class II | Process control | CoLink(TM) Lapidus Plate +2mm Right and Left, were laser marked incorrectly. In these lots, right plates were laser marked as left plates and the left plates were laser marked as right plates. | 48 units | 2019-02-22 |
| 2018-07-16 | Class II | Process control | CoLink(TM) Lapidus Plate +2mm Right and Left, were laser marked incorrectly. In these lots, right plates were laser marked as left plates and the left plates were laser marked as right plates. | 47 units | 2019-02-22 |
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.