# K203041: SMS Cementless Stem

- Pathway: 510(k) (Special)
- Applicant: Medacta International S.A.
- Decided: Dec 2, 2020 after 57 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
Longest line of descent: 11 generations back to K935452 (1994). 102 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 104 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181693: SMS Femoral Stem, Medacta International S.A. (2018) Summary page 4.
- K201673: SMS Cementless Stem, Medacta International S.A. (2020) Summary page 4.
- K192827: Quadra-P, Medacta International S.A. (2020) Summary page 4.

## Most influential descendants
- K250450: Coated hip implants (2025), 0 descendants of its own

## Indications for use
The SMS system is designed for cementless use in total or partial hip arthroplasty, for primary or revision surgery. Hip replacement is indicated in the following cases: Severely painful and/or disabled joint as a result of arthrosis, traumatic arthritis, rheumatoid polyarthritis or congenital hip dysplasia Avascular necrosis of the femoral head Acute traumatic fracture of the femoral head or neck Failure of previous hip surgery: joint reconstruction, internal fixation, arthrodesis, partial hip arthroplasty, hip resurfacing replacement or total hip arthroplasty

Source page: https://510kreport.com/device/K203041
Methodology: https://510kreport.com/methodology