# K001231: The Kalix Implant

- Pathway: 510(k) (Traditional)
- Applicant: New Deal, S.A.
- Decided: Jul 11, 2000 after 85 days
- Product code: HWC (Screw, Fixation, Bone)
- 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.
54 later devices descend from it; 5 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. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K032902: Subtalar Arthrorisis Implant (2003), 49 descendants of its own
- K071498: Subtalar Implant (2007), 32 descendants of its own
- K133636: Extremity Medical Hammertoe Device (2014), 31 descendants of its own
- K141857: CrossTie Intraosseous Fixation System (2015), 16 descendants of its own
- K151270: CrossTIE Intraosseous Fixation System (2015), 15 descendants of its own

Source page: https://510kreport.com/device/K001231
Methodology: https://510kreport.com/methodology