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Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets

The Tracker / October 2025 / K250338

510(k) cleared

MSS - Humeral reverse liners extension

Medacta International S.A. · Oct 31, 2025 · K250338

FDA cleared the MSS - Humeral reverse liners extension from Medacta International S.A. on Oct 31, 2025 under K250338, a traditional 510(k). The device falls under product code PHX, Shoulder Prosthesis, Reverse Configuration, regulated at 21 CFR 888.3660 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Feb 6, 2025. The decision came 267 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: K260173 (M-Vizion Femoral Revision System Extension), K262057 (GMK Extension), K253630 (Mpact 3D Metal Foam), K261016 (MSS - Humeral reverse liners extension).

Questions & Answers

What did FDA clear under K250338?

K250338 is the FDA 510(k) for MSS - Humeral reverse liners extension, submitted by Medacta International S.A.. FDA's decision date was Oct 31, 2025, under product code PHX (Shoulder Prosthesis, Reverse Configuration).

Who makes the MSS - Humeral reverse liners extension?

Medacta International S.A., based in Castel San Pietro, is the applicant of record for K250338.

How long did the K250338 review take?

FDA received the submission on Feb 6, 2025 and issued its decision on Oct 31, 2025, 267 days later.

← All decisions in October 2025