# K013107: Bioabsorbable Interference Screw Megafix

- Pathway: 510(k) (Traditional)
- Applicant: Karl Storz Endoscopy
- Decided: Feb 26, 2002 after 162 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
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K071437: Megafix-C  Bioabsorbable Composite Interference Screw, Model 2870719C, 2870723C, 2870823C, 2870828C, 2870928C (2007), 1 descendant of its own
- K203335: MectaScrew Extension (2022), 0 descendants of its own

## Indications for use
The KSEA Bioabsorbable Interference Screw, MegaFix™ is intended for use by qualified surgeons for tibial and femoral fixation (primary anchorage) of tendon grafts in human cruciate ligament reconstruction.

Source page: https://510kreport.com/device/K013107
Methodology: https://510kreport.com/methodology