# K260173: M-Vizion Femoral Revision System Extension

- Pathway: 510(k) (Traditional)
- Applicant: Medacta International S.A.
- Decided: Sep 17, 2026 after 239 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: 20 generations back to K941847 (1994). 422 ancestors in all.
No later device cites it as a predicate yet.
1 of 422 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212327: M-Vizion Monobloc, Medacta International S.A. (2022) Summary page 6.
- K191816: M-Vizion Femoral Revision System Extension, Medacta International S.A. (2020) Summary page 6.
- K170690: M-Vizion Femoral Revision System, Medacta International S.A. (2017) Summary page 6.
- K112115: Mectacer Biolox (R) Delta Femoral Heads, Medacta International (2011) Summary page 6.
- K151902: REDAPT¿ Revision Femoral System, Smith & Nephew, Inc. (2015) Summary page 6.
- K102080: Depuy Reclaim Revision Hip System, Depuy (Ireland) (2010) Summary page 6.
- K003016: Pro-Femur R, Wrightmedicaltechnologyinc (2000) Summary page 6.
- K241461: Mpact Constrained Liner, Medacta International S.A. (2025) Summary page 6.
- K183141: LINK MP Monoblock Hip Prosthesis, Waldemar Link GmbH & Co. KG (2019) Summary page 7.
- K251292: RECLAIM Monobloc Revision Femoral Stem, Depuy Ireland UC (2025) Summary page 7.
- K201471: M-Vizion Femoral Revision System Extension, Medacta International S.A. (2021) Summary page 7.

## Indications for use
M-Vizion 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. Mpact Constrained Liner Mpact Constrained Liner is intended to be used as part of a Total Hip Arthroplasty, uncemented in combination with the Mpact and Mpact 3D Metal System acetabular shells. Total Hip Arthroplasty is indicated in the following cases: » Severely painful and/or disabled joint as a result of arthrosis, 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, partial hip arthroplasty, hip resurfacing replacement or total hip arthroplasty. Mpact Constrained Liner is intended for primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability and for whom all other options to constrained acetabular components have been considered. Mpact Constrained Liner should be considered only for patients with limited functional demand, as it offers a smaller range of motion than the standard total hip replacement components. MectaCer Biolox® Delta Head The MectaCer BIOLOX® forte femoral heads and the MectaCer BIOLOX®delta femoral heads are intended for mechanical fixation to a mating hip stem and indicated for treatment of patients who are candidates for total or partial hip arthroplasty in primary or revision surgery. The patient should be skeletally mature. The patient’s condition should be due to one or more of the following: » Severely painful and/or disabled joint as a result of osteoarthritis, post-traumatic arthritis, rhreumatoid arthritis, or psoriatic arthritis, » Congenital hip dysplasia, » Ankylosing spondylitis, » 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 where sufficient bone stock is present.

Source page: https://510kreport.com/device/K260173
Methodology: https://510kreport.com/methodology