Duns Number:344203948
Device Description: DescriptionThe SACRONAIL system provides a sustained, stable restoration of dorsal pelvic DescriptionThe 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.
Catalog Number
PBX080194
Brand Name
SACRONAIL
Version/Model Number
Pelvic nail
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K212755
Product Code
HWC
Product Code Name
Screw, Fixation, Bone
Public Device Record Key
9f1b2be2-6672-4669-8497-591175c7ea30
Public Version Date
March 25, 2022
Public Version Number
1
DI Record Publish Date
March 17, 2022
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 522 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1837 |