# K112091: H-Max S Femoral Stems, Modular Femoral Heads, Cemented Cups, Lock Bipolar Heads

- Pathway: 510(k) (Traditional)
- Applicant: Lima Corporate S.P.A.
- Decided: Nov 9, 2012 after 477 days
- Product code: MEH (Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate)
- 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: 6 generations back to K935452 (1994). 16 ancestors in all.
6 later devices descend from it; 4 cite it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042992: Corail Amt Hip Prosthesis, DePuy Orthopaedics, Inc. (2005) Summary page 2.

## Most influential descendants
- K141327: Minima S System (2014), 5 descendants of its own
- 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
- K231925: MINIMA S System (2023), 0 descendants of its own

## Indications for use
The H-Max S stems are indicated for use in total hip arthroplasty and are intended for press-fit (uncemented) use. The H-Max S Stems are intended for use with Co-Cr-Mo femoral heads and Limacorporate standard and protruded cemented cups. The standard and protruded cemented cups are intended for cemented use only. Hip arthropiasty 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 fernoral bone stock.

Source page: https://510kreport.com/device/K112091
Methodology: https://510kreport.com/methodology