# K801594: Ace Fischer External Fixation Device

- Pathway: 510(k) (Traditional)
- Applicant: Ace Orthopedic Manufacturing Co.
- Decided: Sep 9, 1980 after 57 days
- Product code: HXK (Holder, Needle; Orthopedic)
- Device class: 1
- Regulation: 21 CFR 888.4540
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
6 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

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

## Most influential descendants
- K083789: Ace Fischer External Fixation System (2009), 5 descendants of its own
- K190486: Pitkar External Fixation System (2019), 2 descendants of its own
- K202833: Sequel External Fixation Device (2021), 1 descendant of its own
- K253291: Excelsior System (2026), 0 descendants of its own
- K111993: Framewalker (2011), 0 descendants of its own

Source page: https://510kreport.com/device/K801594
Methodology: https://510kreport.com/methodology