Twist-Off
21 catalogue numbers from 110018525, listed by Biomet Orthopedics, United States, under Screw, Fixation, Bone. 31 manufacturers in China are registered for this product code.
31manufacturers in China registered for this device type
21catalogue numbers in this listing
4510(k) clearances naming this product 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 | Biomet Orthopedics, United States |
|---|---|
| FDA product code | HWC |
| Device type | Screw, Fixation, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3040 |
| 510(k) | K142658 |
| Record published | 2021-03-23 |
| Record revised | 2025-05-30 (version 3) |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 110018525 | 2.7 mm X 24 mm | In distribution |
| 110018494 | 2.0 mm X 13 mm | In distribution |
| 110018492 | 2.0 mm X 11 mm | In distribution |
| 110018513 | 2.7 mm X 9 mm | In distribution |
| 110018489 | 2.0 mm X 8 mm | In distribution |
| 110018518 | 2.7 mm X 14 mm | In distribution |
| 110018523 | 2.7 mm X 20 mm | In distribution |
| 110018491 | 2.0 mm X 10 mm | In distribution |
| 110018495 | 2.0 mm X 14 mm | In distribution |
| 110018517 | 2.7 mm X 13 mm | In distribution |
| 110018519 | 2.7 mm X 15 mm | In distribution |
| 110018514 | 2.7 mm X 10 mm | In distribution |
| 110018524 | 2.7 mm X 22 mm | In distribution |
| 110018522 | 2.7 mm X 18 mm | In distribution |
| 110018490 | 2.0 mm X 9 mm | In distribution |
| 110018493 | 2.0 mm X 12 mm | In distribution |
| 110018496 | 2.0 mm X 15 mm | In distribution |
| 110018512 | 2.7 mm X 8 mm | In distribution |
| 110018520 | 2.7 mm X 16 mm | In distribution |
| 110018516 | 2.7 mm X 12 mm | In distribution |
| 110018515 | 2.7 mm X 11 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 |
|---|---|
| K033355 | 2004-06-30 |
| K024086 | 2003-01-09 |
| K021254 | 2002-07-17 |
| K013534 | 2001-12-17 |
Recalls Naming This Product
2 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Biomet, Inc. | 510(k) number | 2019-03-28 | Class II | Under Investigation by firm | There is a potential of fracture, bending or shearing of the driver. | 5885 | 2020-06-02 |
| Biomet, Inc. | 510(k) number | 2019-03-28 | Class II | Under Investigation by firm | There is a potential of fracture, bending or shearing of the driver. | 1924 | 2020-06-02 |
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.