# K936045: Ace Unilateral Fixator II

- Pathway: 510(k) (Traditional)
- Applicant: Ace Orthopedic Manufacturing Co.
- Decided: Feb 22, 1994 after 64 days
- Product code: JEC (Component, Traction, Invasive)
- 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.
3 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K021933: Tempfix External Fixation System (2002), 2 descendants of its own
- K052918: Reprocessed External Fixation Devices (2006), 0 descendants of its own
- K043113: Tempfix External Fixation System, MR Safe (2005), 0 descendants of its own

Source page: https://510kreport.com/device/K936045
Methodology: https://510kreport.com/methodology