WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Exit Postmarket & security

THE TAPE

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 / August 2026 / K253728

510(k) cleared

EVOLUTION® AM BIOFOAM® Tibial System

Microport Orthopedics, Inc. · Aug 21, 2026 · K253728

FDA cleared the EVOLUTION® AM BIOFOAM® Tibial System from Microport Orthopedics, Inc. on Aug 21, 2026 under K253728, a traditional 510(k). The device falls under product code MBH, Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer, regulated at 21 CFR 888.3565 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Nov 24, 2025. The decision came 270 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Microport Orthopedics, Inc. has one other decision in the tracker over the last 12 months: K262473 (NEXUS® Hip Stem).

Questions & Answers

What did FDA clear under K253728?

K253728 is the FDA 510(k) for EVOLUTION® AM BIOFOAM® Tibial System, submitted by Microport Orthopedics, Inc.. FDA's decision date was Aug 21, 2026, under product code MBH (Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer).

Who makes the EVOLUTION® AM BIOFOAM® Tibial System?

Microport Orthopedics, Inc., based in Arlington, TN, is the applicant of record for K253728.

How long did the K253728 review take?

FDA received the submission on Nov 24, 2025 and issued its decision on Aug 21, 2026, 270 days later.

← All decisions in August 2026

Sources