# K033944: Stelkast 32MM Modular Ceramic Femoral Head

- Pathway: 510(k) (Traditional)
- Applicant: Stelkast Company
- Decided: Mar 12, 2004 after 84 days
- Product code: LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3353
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
8 later devices descend from it; 2 cite it directly.
0 of 9 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
- K132158: Novohip Total Hip System (2014), 6 descendants of its own
- K143314: Progressive Orthopaedic Total Hip System (2015), 2 descendants of its own
- K140701: Novohip Bipolar Head/Novohip Vitamin E Liner/ Bone Screws/ Hole Plug (2014), 2 descendants of its own
- K213842: ONVOY Acetabular System (2022), 1 descendant of its own
- K151424: The Progressive Orthopaedic Total Hip System (2016), 1 descendant of its own

## Indications for use
The 32mm Modular Ceramic Femoral Head is a single use device used for reconstruction of the articulating surface of the femoral head portion of the hip that is severely disabled and/or very painful resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis, avascular necrosis, or fracture of the femoral head.

Source page: https://510kreport.com/device/K033944
Methodology: https://510kreport.com/methodology