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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 2026 / K261120

510(k) cleared

APEX 3D S Diamond Tibia

Paragon 28, Inc. · Oct 7, 2026 · K261120

FDA cleared the APEX 3D S Diamond Tibia from Paragon 28, Inc. on Oct 7, 2026 under K261120, a traditional 510(k). The device falls under product code HSN, Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer, regulated at 21 CFR 888.3110 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Apr 3, 2026. The decision came 187 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Paragon 28, Inc. has 6 other decisions in the tracker over the last 12 months: K262722 (Primal K-Wire (P99-193-1410)), K261121 (Megalodon Dynamic Compression System), K262047 (Grappler Suture Anchor System), K253886 (Grappler Suture Anchor PCFD Tether System).

Questions & Answers

What did FDA clear under K261120?

K261120 is the FDA 510(k) for APEX 3D S Diamond Tibia, submitted by Paragon 28, Inc.. FDA's decision date was Oct 7, 2026, under product code HSN (Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer).

Who makes the APEX 3D S Diamond Tibia?

Paragon 28, Inc., based in Englewood, CO, is the applicant of record for K261120.

How long did the K261120 review take?

FDA received the submission on Apr 3, 2026 and issued its decision on Oct 7, 2026, 187 days later.

← All decisions in October 2026