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 / October 2026 / K263086

510(k) cleared

AltiVate Reverse® Glenosphere with RAVN Technology

Encore Medical L.P. · Oct 2, 2026 · K263086

FDA cleared the AltiVate Reverse® Glenosphere with RAVN Technology from Encore Medical L.P. on Oct 2, 2026 under K263086, a special 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 Sep 2, 2026. The decision came 30 days later, inside the 90 FDA-day goal for a 510(k).

Encore Medical L.P. has 3 other decisions in the tracker over the last 12 months: K252567 (AltiVate Reverse® ADLC Glenosphere), K252974 (EMPOWR Knee), K251833 (EMPOWR Acetabular® Liner Extension).

Questions & Answers

What did FDA clear under K263086?

K263086 is the FDA 510(k) for AltiVate Reverse® Glenosphere with RAVN Technology, submitted by Encore Medical L.P.. FDA's decision date was Oct 2, 2026, under product code PHX (Shoulder Prosthesis, Reverse Configuration).

Who makes the AltiVate Reverse® Glenosphere with RAVN Technology?

Encore Medical L.P., based in Austin, TX, is the applicant of record for K263086.

How long did the K263086 review take?

FDA received the submission on Sep 2, 2026 and issued its decision on Oct 2, 2026, 30 days later.

← All decisions in October 2026

Sources