# K121148: Samba Screw, 9MM Dia., 25MM Long, Sambia Screw, 9MM Dia., 30MM Long, Samba Screw 9MM Dia., 35MM Long, Samba Screw, 9MM D

- Pathway: 510(k) (Traditional)
- Applicant: Medical Design, LLC
- Decided: Aug 20, 2012 after 126 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: 6 generations back to K903810 (1990). 11 ancestors in all.
35 later devices descend from it; 4 cite it directly.
0 of 47 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 1.
- K112028: SI-Lok Sacroiliac Joint Fixation System, Globus Medical, Inc. (2011)

## Most influential descendants
- K183342: SambaScrew 3D SI Fusion System (2019), 31 descendants of its own
- K200696: FIREBIRD SI Fusion System (2020), 29 descendants of its own
- K201664: FIREBIRD SI Fusion System (2020), 26 descendants of its own
- K203138: FIREBIRD SI Fusion System (2020), 25 descendants of its own
- K210667: FIREBIRD SI Fusion System (2021), 19 descendants of its own

## Indications for use
The SAMBATM Screw System is intended for fixation of sacroiliac joint disruptions. This fixation device is to only be used in skeletally mature patients.

Source page: https://510kreport.com/device/K121148
Methodology: https://510kreport.com/methodology