# K032824: Stelkast Unicondylar Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Stelkast Company
- Decided: Nov 13, 2003 after 64 days
- Product code: HSX (Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3520
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
62 later devices descend from it; 3 cite it directly.
0 of 63 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K060017: Mako Surgical Unicondylar Knee System (2006), 58 descendants of its own
- K073248: Modification to:Mako Surgical Unicondylar Knee System (2007), 57 descendants of its own
- K080368: Mako Surgical Corp. Unicondylar Knee Implant System II (2008), 56 descendants of its own
- K082172: Mako Modular Knee Compartmental Implant System (2008), 51 descendants of its own
- K090763: Restoris Multicompartmental Knee (MCK) System (2009), 50 descendants of its own

## Recalls of this device
- May 5, 2009 · Not classified · Z-0371-2010: incorrect size markings on component

## Indications for use
1. Moderate joint impairment from painful arthritis (rheumatoid, osteo and/or post-traumatic). 2. Revision of a failed unicompartmental knee implant or other procedure. 3. Alternative to tibial osteotomy in patients with unicompartmental arthritis.

Source page: https://510kreport.com/device/K032824
Methodology: https://510kreport.com/methodology