# K143509: MasterSL femoral stem

- Pathway: 510(k) (Special)
- Applicant: Lima Corporate S.P.A.
- Decided: Jan 27, 2015 after 47 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). 179 ancestors in all.
3 later devices descend from it; 1 cites it directly.
1 of 183 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140975: Mastersl Femoral Stem, Lima Corporate S.P.A. (2014) Summary page 5.
- K141327: Minima S System, Lima Corporate S.P.A. (2014) Summary page 5.

## Most influential descendants
- K150855: H-MAX S Femoral Hip System (2015), 2 descendants of its own
- K160011: H-Max S stem (2016), 1 descendant of its own
- K170473: C2 femoral stem (2017), 0 descendants of its own

## Indications for use
The Master®" 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 Master®" Stems are intended for use with Co-Cr-Mo or ceramic femoral heads and cemented cups, or with Co-Cr-Mo or ceramic femoral heads and Delta TT Acetabular System. When used in partial hip arthroplasty, the Master®" 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; e rheumatoid arthritis; e treatment of femoral head and neck fractures; e revisions in cases of good remaining femoral bone stock.

Source page: https://510kreport.com/device/K143509
Methodology: https://510kreport.com/methodology