# K070016: Blue Shark

- Pathway: 510(k) (Traditional)
- Applicant: Meridan Medical
- Decided: Apr 2, 2007 after 89 days
- Product code: KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component)
- 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: 3 generations back to K803166 (1981). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032427: Fep Fixation System and Stylo Wrist Fixation System, Meridan Medical (2003) Summary page 1.
- K011697: Ebi Xfix Access Pelvic Fixator, Ebi, L.P. (2001) Summary page 1.

## Indications for use
The Blue Shark is an external fixation device indicated for the rigid stabilization of complex fractures of the pelvic girdle. This external fixation device can be utilized for Type 13 and Type C fractures

Source page: https://510kreport.com/device/K070016
Methodology: https://510kreport.com/methodology