# K093900: Edgelock

- Pathway: 510(k) (Traditional)
- Applicant: Orthohelix Surgical Designs, Inc.
- Decided: Feb 17, 2010 after 61 days
- Product code: HRS (Plate, 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
No predicates in its family tree.
53 later devices descend from it; 1 cites it directly.
0 of 54 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
- K113048: Maxlock Extreme System (2012), 52 descendants of its own
- K122005: Maxlock Extreme System (2012), 39 descendants of its own
- K123203: Maxlock Extreme System Model MXL (2012), 38 descendants of its own
- K132591: Maxlock Extreme System (2013), 32 descendants of its own
- K153379: AxSOS 3Ti (2016), 25 descendants of its own

## Indications for use
The Orthol-elix Edgelock Plate System is indicated for fixation of fractures, fusions and osteotornies of the small bones in the hand, wrist, foot and ankle in pediatric and adult patients.

Source page: https://510kreport.com/device/K093900
Methodology: https://510kreport.com/methodology