# K991790: Ultimax Ankle Fusion Rod System

- Pathway: 510(k) (Traditional)
- Applicant: Encore Orthopedics, Inc.
- Decided: Aug 6, 1999 after 72 days
- Product code: HSB (Rod, Fixation, Intramedullary And Accessories)
- Device class: 2
- Regulation: 21 CFR 888.3020
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
54 later devices descend from it; 3 cite it directly.
0 of 55 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
- K023115: Ace Versanail (2002), 41 descendants of its own
- K101934: Dynnail, 12MM, Locking Screw, 4.6 MM, Deployment Frame, Dynnail, Models 1200-01-1222, 1200-02-46XX, 2200-01-0000 (2011), 25 descendants of its own
- K113828: Dynanail Ankle Arthrodesis Nail (2012), 24 descendants of its own
- K171376: DynaNail TTC Fusion System (2017), 22 descendants of its own
- K081243: Biomet Phoenix Ankle Nail System (2008), 18 descendants of its own

## Indications for use
The UltiMax Ankle Fusion Rod System is indicated for single use for arthrodesis of the ankle joint.

Source page: https://510kreport.com/device/K991790
Methodology: https://510kreport.com/methodology