# K240391: MUTARS® femoral stem cemented 160 mm and 200 mm

- Pathway: 510(k) (Traditional)
- Applicant: Implantcast GmbH
- Decided: Oct 24, 2024 after 259 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: 3 generations back to K965164 (1997). 4 ancestors in all.
1 later device descends from it; 1 cites 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)
- K200045: MUTARS Cemented Femoral Stems, Implantcast GmbH (2020) Summary page 7.
- K181778: MUTARS Proximal Femur Replacement System, Implantcast GmbH (2019) Summary page 7.

## Most influential descendants
- 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 for cemented and uncemented use in total hip arthroplasty or hemiarthroplasty 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/K240391
Methodology: https://510kreport.com/methodology