# K803166: Double Ball Joint

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Corp.
- Decided: Jan 9, 1981 after 25 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.
7 later devices descend from it; 1 cites it directly.
0 of 8 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
- K952730: Hoffmann II External Fixation System (1995), 6 descendants of its own
- K110965: Renovis T 710 Large External Fixation System (2011), 2 descendants of its own
- K032427: Fep Fixation System and Stylo Wrist Fixation System (2003), 2 descendants of its own
- K213905: ONX Large External Fixation System (2022), 0 descendants of its own
- K171211: OIC External Fixation System (2017), 0 descendants of its own

Source page: https://510kreport.com/device/K803166
Methodology: https://510kreport.com/methodology