# K140975: Mastersl Femoral Stem

- Pathway: 510(k) (Traditional)
- Applicant: Lima Corporate S.P.A.
- Decided: Jun 10, 2014 after 55 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: 8 generations back to K921308 (1994). 92 ancestors in all.
4 later devices descend from it; 1 cites it directly.
1 of 97 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972791: Encore Linear Hip, Encore Orthopedics, Inc. (1998) Summary page 2.
- K991325: Modification of Encore Linear Porous Coated Hip, Encore Orthopedics, Inc. (1999) Summary page 2.
- K112158: Modulus Stems, Modulus Necks, Modular Femoral Heads, Cemented Cups, Lock Bipolar Heads, Lima Corporate S.P.A. (2012) Summary page 2.
- K043537: Taperloc 12/14 Taper Femoral Components, Biomet, Inc. (2005) Summary page 2.

## Cited in the summary but kept off the family tree
- K120091: R&D Innovation Pedicle Screw System, R&D Innovation, LLC (2012). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K143509: MasterSL femoral stem (2015), 3 descendants of its own
- 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 MasterSL 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 SL Stems are intended for use with Ca-Cr-Mo femnoral heads and cemented cups or with Co-Cr-Mo, femoral heads and Delta TI' Acetabular System. When used in partial hip arthraplasty, the MasterSL 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 fractures; * revisions in cases of good remaining femoral bone stock.

Source page: https://510kreport.com/device/K140975
Methodology: https://510kreport.com/methodology