# K040483: Equestra Fluid Delivery System

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Sofamor Danek, Inc.
- Decided: Jul 23, 2004 after 149 days
- Product code: HRX (Arthroscope)
- Device class: 2
- Regulation: 21 CFR 888.1100
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
52 later devices descend from it; 6 cite it directly.
1 of 53 devices in its family (counting itself) has 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) bone tamps: named in the summary without a submission number
- (no number) cannulas: named in the summary without a submission number
- (no number) stylets: named in the summary without a submission number

## Most influential descendants
- K043602: Quadrant Retractor System (2005), 29 descendants of its own
- K060148: Ebi Vertebroplasty Systems (2006), 18 descendants of its own
- K063248: Arcuate Vertebral Augmentation System (2007), 17 descendants of its own
- K062038: X-Sten Mild Tool Kit, Model MTK-0001 (2006), 14 descendants of its own
- K093062: Vertos Medical Mild Device Kit (2010), 13 descendants of its own

## Indications for use
The EQUESTRATM Delivery System is intended to provide surgeons with a percutaneous means of delivering legally cleared bone cement to the surgical site in orthopedic procedures.

Source page: https://510kreport.com/device/K040483
Methodology: https://510kreport.com/methodology