# K160011: H-Max S stem

- Pathway: 510(k) (Traditional)
- Applicant: Lima Corporate S.P.A.
- Decided: Aug 22, 2016 after 231 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: 12 generations back to K810258 (1981). 231 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 233 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 5.
- K150855: H-MAX S Femoral Hip System, Lima Corporate S.P.A. (2015) Summary page 5.
- K130728: Polarstem Standard and Lateral Femoral Stems with TI/HA, Smith & Nephew, Inc. (2013) Summary page 5.

## Most influential descendants
- K170473: C2 femoral stem (2017), 0 descendants of its own

## Indications for use
The H-Max S stems are indicated for use in total and partial hip arthroplasty and are intended for press-fit (uncemented) use. The H-Max S Stem are intended for use with CoCrMo femoral heads or Biolox Delta femoral heads and Limacorporate cemented acetabular cups or cementless Delta TT acetabular cups. In partial Hip arthroplasty H-Max S stem is intended for use with Limacorporate 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; theumatoid arthritis; treatment of femoral head and neck fractures; revisions in cases of good remaining femoral bone stock.

Source page: https://510kreport.com/device/K160011
Methodology: https://510kreport.com/methodology