# K201471: M-Vizion Femoral Revision System Extension

- Pathway: 510(k) (Traditional)
- Applicant: Medacta International S.A.
- Decided: Jan 11, 2021 after 222 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: 10 generations back to K921308 (1994). 48 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 52 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191816: M-Vizion Femoral Revision System Extension, Medacta International S.A. (2020) Summary page 4.

## Most influential descendants
- K212327: M-Vizion Monobloc (2022), 1 descendant of its own
- K260173: M-Vizion Femoral Revision System Extension (2026), 0 descendants of its own
- K220405: Amis K Long (2022), 0 descendants of its own

## Indications for use
The hip prosthesis M-Vizion is designed for cementless use in total or partial hip arthroplasty in primary or revision surgery. Hip Replacement is indicated in the following cases: • Severely painful and/or disabled joint as a result of arthritis, traumatic arthritis, rheumatoid polyarthritis, or congenital hip dysplasia. • Avascular necrosis of the femoral head. • Acute traumatic fracture of the femoral head or neck. • Failure of previous hip surgery: joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.

Source page: https://510kreport.com/device/K201471
Methodology: https://510kreport.com/methodology