# K231925: MINIMA S System

- Pathway: 510(k) (Special)
- Applicant: Lima Corporate S.P.A.
- Decided: Jul 11, 2023 after 11 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: 10 generations back to K810258 (1981). 190 ancestors in all.
No later device cites it as a predicate yet.
1 of 191 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141327: Minima S System, Lima Corporate S.P.A. (2014) Summary page 4.
- K201673: SMS Cementless Stem, Medacta International S.A. (2020) Summary page 4.

## Indications for use
The MINIMA S System stems are indicated for use in partial or total hip arthroplasty and are intended for press-fit (uncemented) use. When used in total hip arthroplasty, the MINIMA S Stems are intended for use with compatible femoral heads and acetabular components. When used in partial hip arthroplasty, the MINIMA S stems are intended for use with Lock Bipolar Heads. Hip arthroplasty is intended for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: • non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis and hip dysplasia; • rheumatoid arthritis; • treatment of femoral head and neck fracture; • revisions in cases of good remaining femoral bone stock.

Source page: https://510kreport.com/device/K231925
Methodology: https://510kreport.com/methodology