# K050407: Ligafix Resorbable Interference Screw, Models 30 and 60

- Pathway: 510(k) (Traditional)
- Applicant: Sciences For Bio Materials
- Decided: Nov 4, 2005 after 260 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: 2 generations back to K994337 (2000). 3 ancestors in all.
7 later devices descend from it; 5 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002070: Biolok Screw, Biocomposites, Ltd. (2000) Summary page 1.
- K021963: Biosorb Resorbable Void Filler, Sciences ET Bio Materiaux (Sbm) (2003) Summary page 1.

## Most influential descendants
- K061262: Ligafix Interference Screw (2006), 6 descendants of its own
- K070507: Modification to: Ligafix Interference Screw (2007), 3 descendants of its own
- K090994: Ligafix Interface Screw (2009), 2 descendants of its own
- K122228: Ligafix Interference Screw (2012), 1 descendant of its own
- K071437: Megafix-C  Bioabsorbable Composite Interference Screw, Model 2870719C, 2870723C, 2870823C, 2870828C, 2870928C (2007), 1 descendant of its own

## Indications for use
LIGAFIX t is a cannulated, sterile, single-use, resorbable interference bone screw made of a mixture of tri calcium phosphate (13-TCP) and Poly Lactic Acid (PLA) designed for the interference fixation of grafts in anterior cruciate ligament reconstruction.

Source page: https://510kreport.com/device/K050407
Methodology: https://510kreport.com/methodology