# K212755: SIGNUS SACRONAIL® Transsacral Stabilization System

- Pathway: 510(k) (Traditional)
- Applicant: Signus Medizintechnik GmbH
- Decided: Mar 10, 2022 after 191 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K962616 (1996). 134 ancestors in all.
No later device cites it as a predicate yet.
0 of 135 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001720: Synthes Sacral Bar System, Synthes (Usa) (2000) Summary page 5.
- K203381: Dynanail Mini Hybrid, MedShape, Inc. (2021) Summary page 5.
- K161616: DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm Cannulated Screws, DePuy Synthes 3.5 mm and 4.0 mm Cannulated Screws, DePuy Synthes 4.5 mm Cannulated Screws, DePuy Synthes 6.5 mm Cannulated Screws, DePuy Synthes 7.0 mm and 7.3 mm Cannulated Screws, DePuy Synthes 1.5 mm Headless Compression Screws, DePuy Synthes 2.4 mm Headless Compression Screws, DePuy Synthes 3.0 mm Headless Compression Screws, DePuy Synthes 4.5 mm and 6.5 mm Headless Compression Screw, Synthes USA Products, LLC (2017) Summary page 5.
- K171595: M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System, Medacta International S.A. (2017) Summary page 5.

## Indications for use
The SIGNUS SACRONAIL® Transsacral Stabilization System is intended for fixation of fractures of the posterior pelvis, in areas of superior posterior iliac spine and posterior inferior iliac spine, for sacral fractures and fracture-dislocations of the sacro-iliac joint.

Source page: https://510kreport.com/device/K212755
Methodology: https://510kreport.com/methodology