# K122228: Ligafix Interference Screw

- Pathway: 510(k) (Special)
- Applicant: Sbm Sciences For Bio Materials
- Decided: Oct 3, 2012 after 69 days
- Product code: MAI (Fastener, Fixation, Biodegradable, Soft Tissue)
- Device class: 2
- Regulation: 21 CFR 888.3030
- 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 K994337 (2000). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050407: Ligafix Resorbable Interference Screw, Models 30 and 60, Sciences For Bio Materials (2005) Summary page 1.
- K061262: Ligafix Interference Screw, Sciences For Bio Materials (2006) Summary page 1.
- K070507: Modification to: Ligafix Interference Screw, Science For Biomaterials (2007) Summary page 1.
- K090994: Ligafix Interface Screw, Science For Biomaterials (2009) Summary page 1.

## Most influential descendants
- K230394: Euroscrew NG; Euroscrew TCP NG (2023), 0 descendants of its own

## Indications for use
LIGAFIX® / ComposiTCP® is a cannulated, sterile, single-use, resorbable interference bone screw made of a mixture of tri calcium phosphate (beta-TCP) and Poly Lactic Acid (PLA) designed for the interference fixation of grafts in anterior cruciate ligament reconstruction.

Source page: https://510kreport.com/device/K122228
Methodology: https://510kreport.com/methodology