# K261121: Megalodon Dynamic Compression System

- Pathway: 510(k) (Traditional)
- Applicant: Paragon 28, Inc.
- Decided: Aug 6, 2026 after 125 days
- Product code: JDR (Staple, Fixation, Bone)
- 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: 4 generations back to K001354 (2001). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K230550: JAWS Nitinol Staple System, Paragon 28, Inc. (2023) Summary page 5.

## Indications for use
The Megalodon Dynamic Compression System implants are indicated for use in osteotomy, arthrodesis and fragment fixation of bones and joint of the foot including fixation of small bone fragments (i.e., small fragments of bone which are not comminuted to the extent to preclude staple placement) located in the long bones of the lower extremities such as the fibula and tibia.

Source page: https://510kreport.com/device/K261121
Methodology: https://510kreport.com/methodology