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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 / January 2026 / K251043

510(k) cleared

Mpact 3D Metal Implants Extension DMLS Technology

Medacta International S.A. · Jan 28, 2026 · K251043

FDA cleared the Mpact 3D Metal Implants Extension DMLS Technology from Medacta International S.A. on Jan 28, 2026 under K251043, a traditional 510(k). The device falls under product code LPH, Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented, regulated at 21 CFR 888.3358 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Apr 3, 2025. The decision came 300 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 K251043?

K251043 is the FDA 510(k) for Mpact 3D Metal Implants Extension DMLS Technology, submitted by Medacta International S.A.. FDA's decision date was Jan 28, 2026, under product code LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented).

Who makes the Mpact 3D Metal Implants Extension DMLS Technology?

Medacta International S.A., based in Castel San Pietro, is the applicant of record for K251043.

How long did the K251043 review take?

FDA received the submission on Apr 3, 2025 and issued its decision on Jan 28, 2026, 300 days later.

← All decisions in January 2026