# K053093: Kalix II Implant, Model 141 0XX with XX

- Pathway: 510(k) (Special)
- Applicant: New Deal, S.A.
- Decided: Dec 7, 2005 after 34 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
Longest line of descent: 1 generation back to K001231 (2000). 1 ancestor in all.
3 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001231: The Kalix Implant, New Deal, S.A. (2000) Summary page 1.

## Most influential descendants
- K061765: Kalix II Implant (2006), 2 descendants of its own
- K170688: PIT’Stop® implant (2017), 1 descendant of its own
- K222820: BRM TOOL Screws, BIOPLAN Subtalar Implant (2022), 0 descendants of its own

## Indications for use
The KALIX II implant is indicated for use in the treatment of the hyperpronated foot and stabilization of the subtalar joint. It is designed to block forward, downward and medial displacement of the talus, thus allowing normal subtalar joint motion but blocking excessive pronation and the resulting sequela. - flat foot treatment in children and adolescents - congenital flat foot - non successful long term orthopaedic treatment (shoes, insoles...) - tarsal coalitions - painfully flat foot - supple deformity in posterior tibial tendon dysfunction - paralytic flat foot - subtalar instability.

Source page: https://510kreport.com/device/K053093
Methodology: https://510kreport.com/methodology