Sacronail
The SACRONAIL system provides a sustained, stable restoration of dorsal pelvic fractures and sacral fractures through its intraosseous location and its direct, bi-iliac symmetric anchorage.…
The SACRONAIL system provides a sustained, stable restoration of dorsal pelvic fractures and sacral fractures through its intraosseous location and its direct, bi-iliac symmetric anchorage. The implant consists of a nail of various lengths from135mm to 194mm with a constant diameter of 8mm and 2 locking screws in different lengths. This variation ensures adaptation to the respective anatomy of the patient. The intersections of the screw axes to the implant axis have a distance of 15mm to the respective end face of the nail. This ensures a solid support on the lateral cortex of the Ilia. The angle of the screw axes to the implant axis corresponds to the anatomical conditions and is 70°. The locking screw ensures a stable connection of the components. The tips of the locking screws are rounded to facilitate insertion into the nail while the dorsal ends of locking screws are a hexagon. The caps serve to close the instrument connection of the nail. The implants are made from the Titanium alloy (Ti6Al4V) according to ASTM F 136 / ISO 5832-3, with a Type II anodization according to AMS 2488. There are Instruments which are specific to the implantation of the SACRONAIL device. These include, but are not limited to, the Guide Frame, the Guide Bracket, the Fixation Bracket, various Instrument Guides, various dilators and drills, screwdrivers as well as the specific tools for revision of the device.
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 | Signus Medizintechnik Gmbh, Germany |
|---|---|
| FDA product code | HWC |
| Device type | Screw, Fixation, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3040 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K212755 |
| Record published | 2022-03-17 |
| Record revised | 2025-02-06 (version 4) |
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 |
| Storage | Storage environment temperature 0 to 35 °C |
| Packaging | Pack of 2 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Locking screw | ventral 30mm/dorsal 50mm | In distribution |
| Pelvic nail | Ø8mm,160mm | In distribution |
| Instrument guide | 148/157/163/178/194mm | In distribution |
| Compression sleeve, tip | In distribution | |
| Pelvic nail | Ø8mm,190mm | In distribution |
| Screw plug | 5mm | In distribution |
| Pelvic nail | Ø8mm,186mm | In distribution |
| Compression sleeve, handle | In distribution | |
| Compression sleeve, handle | In distribution | |
| Aiming device | In distribution | |
| Pelvic nail | Ø8mm,148mm | In distribution |
| Pelvic nail | Ø8mm,166mm | In distribution |
| Compression sleeve, tip | In distribution | |
| Pelvic nail | Ø8mm,140mm | In distribution |
| Locking screw | ventral 50mm/dorsal 50mm | In distribution |
| Screw pelvic nail | In distribution | |
| Pelvic nail | Ø8mm,194mm | In distribution |
| Instrument guide | 140/154/170/186mm | In distribution |
| Locking screw | ventral 30mm/dorsal 45mm | In distribution |
| Locking screw | ventral 50mm/dorsal 55mm | In distribution |
| Pelvic nail | Ø8mm,174mm | In distribution |
| Pelvic nail | Ø8mm,135mm | In distribution |
| Pelvic nail | Ø8mm,151mm | In distribution |
| Pelvic nail | Ø8mm,170mm | In distribution |
| Locking screw | ventral 50mm/dorsal 35mm | In distribution |
| Pelvic nail | Ø8mm,163mm | In distribution |
| Clamping screw | In distribution | |
| Anvil | In distribution | |
| Fixation screw | In distribution | |
| Locking screw | ventral 50mm/dorsal 30mm | In distribution |
| Locking screw | ventral 30mm/dorsal 55mm | In distribution |
| Locking screw | ventral 30mm/dorsal 35mm | In distribution |
| Locking screw | ventral 30mm/dorsal 30mm | In distribution |
| Instrument guide | 140/154/170/186mm | In distribution |
| Screw plug | 20mm | In distribution |
| Locking screw | ventral 50mm/dorsal 45mm | In distribution |
| Locking screw | ventral 50mm/dorsal 40mm | In distribution |
| Locking screw | ventral 50mm/dorsal 60mm | In distribution |
| Pelvic nail | Ø8mm,154mm | In distribution |
| Fixation arm | In distribution | |
| Instrument guide | 135/151/166/182mm | In distribution |
| Locking screw | ventral 30mm/dorsal 60mm | In distribution |
| Pelvic nail | Ø8mm,145mm | In distribution |
| Clamping screw | In distribution | |
| Pelvic nail | Ø8mm,157mm | In distribution |
| Pelvic nail | Ø8mm,178mm | In distribution |
| Instrument guide | 145/160/174/190mm | In distribution |
| Anvil | In distribution | |
| Screw pelvic nail | In distribution | |
| Instrument guide | 135/151/166/182mm | In distribution |
| Locking screw | ventral 30mm/dorsal 40mm | In distribution |
| Instrument guide | 145/160/174/190mm | In distribution |
| Instrument guide | 148/157/163/178/194mm | In distribution |
| Aiming device | In distribution | |
| Pelvic nail | Ø8mm,182mm | 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 |
|---|---|
| K212755 | 2022-03-10 |
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.