Biosteon® Screw
The Biosteon® ACL Screw is a cannulated, single-use bone screw made of a resorbable Poly (L-lactic) Acid and Calcium Phosphate which will be gradually resorbed into the body. this function…
The Biosteon® ACL Screw is a cannulated, single-use bone screw made of a resorbable Poly (L-lactic) Acid and Calcium Phosphate which will be gradually resorbed into the body. this function however, is patient dependent.
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 | Biocomposites Ltd., United Kingdom |
|---|---|
| FDA product code | HWC |
| Device type | Screw, Fixation, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3040 |
| Establishment | Specification developer, Manufacturer |
| Record published | 2015-05-31 |
| Record revised | 2024-01-03 (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 |
| Storage | Storage environment temperature 39 to 117 °F; Storage environment temperature 4 to 47 °C |
| Sizes | Width 6 to 12 mm; length 23 to 35 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 234-010-160 | Width 6 mm | In distribution |
| 234-010-163 | Length 23 mm | In distribution |
| 234-010-165 | Width 8 mm | In distribution |
| 234-010-177 | Width 9 mm | In distribution |
| 234-010-167 | Width 10 mm | In distribution |
| 234-010-172 | Width 11 mm | In distribution |
| 234-010-166 | Width 9 mm | In distribution |
| 234-010-179 | Width 11 mm | In distribution |
| 234-010-180 | Width 12 mm | In distribution |
| 234-010-161 | Length 23 mm | In distribution |
| 234-010-168 | Length 28 mm | In distribution |
| 234-010-164 | Length 28 mm | In distribution |
| 234-010-170 | Length 23 mm | In distribution |
| 234-010-162 | Length 23 mm | In distribution |
| 234-010-173 | Width 12 mm | In distribution |
| 234-010-178 | Width 10 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 |
|---|---|
| K081428 | 2008-06-20 |
| K072127 | 2007-08-31 |
| K071952 | 2007-08-14 |
| K071091 | 2007-05-17 |
| K071115 | 2007-05-17 |
| K061949 | 2006-09-25 |
| K040265 | 2004-05-28 |
| K033792 | 2004-03-01 |
| K021351 | 2002-10-17 |
| K003641 | 2001-02-08 |
| K002070 | 2000-08-25 |
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.