# K212327: M-Vizion Monobloc

- Pathway: 510(k) (Traditional)
- Applicant: Medacta International S.A.
- Decided: May 24, 2022 after 301 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: 11 generations back to K921308 (1994). 49 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 51 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201471: M-Vizion Femoral Revision System Extension, Medacta International S.A. (2021) Summary page 4.
- K191816: M-Vizion Femoral Revision System Extension, Medacta International S.A. (2020) Summary page 4.
- K170690: M-Vizion Femoral Revision System, Medacta International S.A. (2017) Summary page 4.
- K953689: Wagner Revision Stem (Modification), Intermedics Orthopedics (1995) Summary page 4.
- K043356: Wagner SL Revision Stem Lateral, Zimmer Austin, Inc. (2005) Summary page 4.
- K113556: Wagner Cone Prosthesis System, Zimmer GmbH (2012) Summary page 4.

## Most influential descendants
- K260173: M-Vizion Femoral Revision System Extension (2026), 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/K212327
Methodology: https://510kreport.com/methodology