# K201673: SMS Cementless Stem

- Pathway: 510(k) (Traditional)
- Applicant: Medacta International S.A.
- Decided: Sep 18, 2020 after 91 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: 9 generations back to K921308 (1994). 69 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 73 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071723: Zimmer Porolock Mis Stem, Zimmer GmbH (2008) Summary page 4.
- K181693: SMS Femoral Stem, Medacta International S.A. (2018) Summary page 4.

## Most influential descendants
- K203041: SMS Cementless Stem (2020), 1 descendant of its own
- K250450: Coated hip implants (2025), 0 descendants of its own
- K231925: MINIMA S System (2023), 0 descendants of its own

## Indications for use
The hip prosthesis SMS 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/K201673
Methodology: https://510kreport.com/methodology