# K030848: Perforated Bioabsorbable Interference Screw Megafix

- Pathway: 510(k) (Traditional)
- Applicant: Karl Storz Endoscopy
- Decided: Jun 2, 2003 after 77 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.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
The KSEA Perforated 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/K030848
Methodology: https://510kreport.com/methodology