# K181778: MUTARS Proximal Femur Replacement System

- Pathway: 510(k) (Traditional)
- Applicant: Implantcast GmbH
- Decided: Mar 25, 2019 after 265 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: 1 generation back to K965164 (1997). 2 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K965164: Howmedica Modular Replacement System-Proximal Femur, Howmedica Corp. (1997) Summary page 4.
- K023087: Global Modular Replacement System (GMRS), Howmedica Osteonics Corp. (2002) Summary page 4.

## Most influential descendants
- K200045: MUTARS Cemented Femoral Stems (2020), 2 descendants of its own
- K240391: MUTARS® femoral stem cemented 160 mm and 200 mm (2024), 1 descendant of its own
- K260037: implantcast Packaging System Update (2026), 0 descendants of its own

## Indications for use
The MUTARS® Proximal Femur Replacement System is a modular hip replacement system offering various components that can be combined to replace the hip joint and address major bone defects with various options depending upon the size and location of the defects of each patient. The MUTARS® Proximal Femur System is intended to for uncemented use in total hip arthroplasty for the following indications: - Proximal femur replacement in oncology cases where radical resection and replacement of bone is required. - Limb salvage procedures including surgical intervention for severe trauma, failed previous prosthesis, and/or oncology indications, where radical resection and replacement of the bone is required. Use of this prosthesis is generally only indicated in skeletally mature patients

Source page: https://510kreport.com/device/K181778
Methodology: https://510kreport.com/methodology