Stabilis™
16 catalogue numbers from AFPSC4565, listed by Tornier Inc., United States, under Screw, Fixation, Bone. 31 manufacturers in China are registered for this product code.
31manufacturers in China registered for this device type
16catalogue numbers in this listing
2510(k) clearances naming this product code
4recalls 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 | Tornier 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, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2015-09-25 |
| Record revised | 2025-11-20 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number |
| Sizes | Length 18 to 70 mm; outer diameter 4.5 to 9 mm; width 10 to 20 mm |
| Distribution end date | 2022-11-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| AFPSC4565 | Length 65 mm | Withdrawn |
| AFPATTH | Length 70 mm | Withdrawn |
| AFPSC4540 | Outer Diameter 4.5 mm | Withdrawn |
| AFPSC4524 | Length 24 mm | Withdrawn |
| AFPSC4528 | Length 28 mm | Withdrawn |
| AFPSC4518 | Outer Diameter 4.5 mm | Withdrawn |
| AFPSC4545 | Length 45 mm | Withdrawn |
| AFPSC4534 | Outer Diameter 4.5 mm | Withdrawn |
| AFPW | Outer Diameter 9 mm | Withdrawn |
| AFPSC4560 | Length 60 mm | Withdrawn |
| AFPCPTR | Length 20 mm | Withdrawn |
| AFPSC4536 | Outer Diameter 4.5 mm | Withdrawn |
| AFPSC4526 | Outer Diameter 4.5 mm | Withdrawn |
| AFPAUG | Length 52 mm | Withdrawn |
| AFPSC4520 | Length 20 mm | Withdrawn |
| AFPSC4530 | Length 30 mm | Withdrawn |
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 |
|---|---|
| K150871 | 2015-08-04 |
| K970829 | 1998-12-22 |
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 |
|---|---|---|---|---|---|
| 2010-03-23 | Not classified | Employee error | On 3/9/10 it was discovered that the recalling firm packaged MFT-021-35-24 Screws from lot 0964092 as MFT-021-35-22 lot 0964081. | 62 pieces | 2012-09-10 |
| 2010-01-29 | Class II | Software design (manufacturing process) | The tips of the drivers are breaking while being used to drive the screws into patients. | 120 Pieces | 2013-02-20 |
| 2010-01-29 | Class II | Software design (manufacturing process) | The tips of the drivers are breaking while being used to drive the screws into patients. | 47 Pieces | 2013-02-20 |
| 2009-04-07 | Not classified | Other | A pinhead sized disc was found in the cannulation of a MSD-010-55-60S screw. | 45 pieces | 2010-10-20 |
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.