5MS™
Compression Drill Guide, Ø1.6 & Ø1.9, Assy
31manufacturers in China registered for this device type
72catalogue 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 |
| 510(k) | K170518 |
| Record published | 2017-08-14 |
| Record revised | 2025-11-20 (version 10) |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| P60 ST547 | In distribution | |
| P60 ST032 | In distribution | |
| P06 N1031 | In distribution | |
| P62 ST711 | In distribution | |
| P62 ST426 | In distribution | |
| P62 ST408 | In distribution | |
| P64 ST413 | In distribution | |
| P06 N0251 | In distribution | |
| P06 N1032 | In distribution | |
| P06 N1041 | In distribution | |
| P64 ST422 | In distribution | |
| P64 ST430 | In distribution | |
| P64 ST711 | In distribution | |
| P06 N0581 | In distribution | |
| P60 ST565 | In distribution | |
| P62 ST414 | In distribution | |
| P60 ST552 | In distribution | |
| P64 ST722 | In distribution | |
| P60 ST645 | In distribution | |
| P62 ST709 | In distribution | |
| P62 ST718 | In distribution | |
| P60 ST050 | In distribution | |
| P60 ST022 | In distribution | |
| P62 ST713 | In distribution | |
| P06 N1042 | In distribution | |
| P64 ST730 | In distribution | |
| P06 N1012 | In distribution | |
| P60 ST640 | In distribution | |
| P62 ST418 | In distribution | |
| P62 ST430 | In distribution | |
| P64 ST426 | In distribution | |
| P06 N1023 | In distribution | |
| P60 ST542 | In distribution | |
| P60 ST447 | In distribution | |
| P60 ST442 | In distribution | |
| P60 ST012 | In distribution | |
| P64 ST713 | In distribution | |
| P64 ST415 | In distribution | |
| P64 ST411 | In distribution | |
| P60 ST660 | In distribution | |
| P06 N0591 | In distribution | |
| P62 ST722 | In distribution | |
| P64 ST718 | In distribution | |
| P64 ST709 | In distribution | |
| P64 ST715 | In distribution | |
| P62 ST730 | In distribution | |
| P62 ST410 | In distribution | |
| P06 N0011 | In distribution | |
| P64 ST409 | In distribution | |
| P60 ST042 | In distribution | |
| P06 N1024 | In distribution | |
| P64 ST418 | In distribution | |
| P06 N1021 | In distribution | |
| P60 ST470 | In distribution | |
| P62 ST422 | In distribution | |
| P62 ST715 | In distribution | |
| P06 N0141 | In distribution | |
| P60 ST034 | In distribution | |
| P06 N0131 | In distribution | |
| P62 ST412 | In distribution | |
| P62 ST726 | In distribution | |
| P60 ST557 | In distribution | |
| P06 N1011 | In distribution | |
| P60 ST452 | In distribution | |
| P60 ST650 | In distribution | |
| P64 ST726 | In distribution | |
| P06 N1022 | In distribution | |
| P60 ST457 | In distribution | |
| P60 ST670 | In distribution | |
| P60 ST655 | In distribution | |
| P62 ST416 | In distribution | |
| P06 N1051 | 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.