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.…

Registry build 21.09.26

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.

31manufacturers in China registered for this device type
55catalogue numbers in this listing
1510(k) clearance

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.

Chinese manufacturers registered for FDA product code HWC
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

Regulatory record for Sacronail
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

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 numbers for Sacronail
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

Other products under the same FDA 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

FDA 510(k) clearances naming this product code
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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer