# K001720: Synthes Sacral Bar System

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Aug 24, 2000 after 79 days
- Product code: JDW (Pin, Fixation, Threaded)
- 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
No predicates in its family tree.
17 later devices descend from it; 3 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Zimmer Threaded Sacral Rod: named in the summary without a submission number
- (no number) Synthes Threaded Bolt: named in the summary without a submission number

## Most influential descendants
- K063166: I.T.S. Pelvic Reconstruction System (2006), 9 descendants of its own
- K192745: DePuy Synthes Trauma Screws (2019), 5 descendants of its own
- K122538: Acumed Pelvic Bone Plate System (2012), 4 descendants of its own
- K210935: I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix) (2022), 3 descendants of its own
- K161894: SurgTech Trauma System (2017), 3 descendants of its own

## Indications for use
The Synthes Sacral Bar System is intended for fixation of fractures of the posterior pelvis, in areas of the posterior superior iliac spine and posterior inferior iliac spine, for sacral fractures and fracture-dislocations of the sacro-iliac joint.

Source page: https://510kreport.com/device/K001720
Methodology: https://510kreport.com/methodology