# K220274: Kisar Stratford SI Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Anjali Investments L.L.C
- Decided: Apr 24, 2023 after 448 days
- Product code: OUR (Sacroiliac Joint Fixation)
- 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: 16 generations back to K841189 (1984). 128 ancestors in all.
No later device cites it as a predicate yet.
0 of 129 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021932: Synthes 6.5 MM Cannulated Screw, Synthes (Usa) (2002) Summary page 4.
- K191748: Genesys Spine Sacroiliac Joint Fusion System, Genesys Spine (2019) Summary page 4.
- K152237: The Entasis Dual-Lead Sacroiliac Implant, Corelink, LLC (2016) Summary page 4.

## Indications for use
The Kisar Stratford SI Screw system is intended for fusion of the sacroiliac joint for conditions including SI joint dysfunction resulting from SI joint disruption or degenerative sacroiliitis.

Source page: https://510kreport.com/device/K220274
Methodology: https://510kreport.com/methodology