# K150855: H-MAX S Femoral Hip System

- Pathway: 510(k) (Special)
- Applicant: Lima Corporate S.P.A.
- Decided: Oct 21, 2015 after 204 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: 11 generations back to K810258 (1981). 223 ancestors in all.
2 later devices descend from it; 2 cite it directly.
1 of 226 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112091: H-Max S Femoral Stems, Modular Femoral Heads, Cemented Cups, Lock Bipolar Heads, Lima Corporate S.P.A. (2012) Summary page 6.
- K141327: Minima S System, Lima Corporate S.P.A. (2014) Summary page 6.
- K143509: MasterSL femoral stem, Lima Corporate S.P.A. (2015) Summary page 6.
- K112158: Modulus Stems, Modulus Necks, Modular Femoral Heads, Cemented Cups, Lock Bipolar Heads, Lima Corporate S.P.A. (2012) Summary page 6.
- K112898: Delta TT Cups, Delta TT Liners, Bone Screws, Lima Corporate S.P.A. (2012) Summary page 6.
- K141395: Delta TT Acetabular System, Lima Corporate S.P.A. (2014) Summary page 6.

## Most influential descendants
- 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 H-MAX S Femoral Hip System consists of the H-MAX S femoral stem, a modular femoral head, and an acetabular cup. In total hip arthroplasty, the H-Max S Stems are intended for use with modular CoCrMo femoral heads or Biolox Delta ceramic femoral heads and a compatible Limacorporate Cemented Cup or uncemented Delta TT acetabular cup. 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; osteoarthritis after femoral heads fractures; revisions in cases of good remaining femoral bone stock. The Limacorporate Cemented Cup is intended for cemented use in hip arthroplasty where the acetabular socket needs reconstruction. The Limacorporate Delta TT Cup is intended for uncemented use.

Source page: https://510kreport.com/device/K150855
Methodology: https://510kreport.com/methodology