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The Tracker / September 2026 / K260173

510(k) cleared

M-Vizion Femoral Revision System Extension

Medacta International S.A. · Sep 17, 2026 · K260173

FDA cleared the M-Vizion Femoral Revision System Extension from Medacta International S.A. on Sep 17, 2026 under K260173, a traditional 510(k). The device falls under product code LZO, Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented, regulated at 21 CFR 888.3353 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Jan 21, 2026. The decision came 239 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Medacta International S.A. has 8 other decisions in the tracker over the last 12 months: K262057 (GMK Extension), K253630 (Mpact 3D Metal Foam), K261016 (MSS - Humeral reverse liners extension), K254202 (MectaLIF 3D Metal Anterior).

Questions & Answers

What did FDA clear under K260173?

K260173 is the FDA 510(k) for M-Vizion Femoral Revision System Extension, submitted by Medacta International S.A.. FDA's decision date was Sep 17, 2026, under product code LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented).

Who makes the M-Vizion Femoral Revision System Extension?

Medacta International S.A., based in Castel San Pietro, is the applicant of record for K260173.

How long did the K260173 review take?

FDA received the submission on Jan 21, 2026 and issued its decision on Sep 17, 2026, 239 days later.

← All decisions in September 2026