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 / March 2026 / K253591

510(k) cleared

Phantom® Hindfoot TTC/TC Nail System

Paragon 28, Inc. · Mar 5, 2026 · K253591

FDA cleared the Phantom® Hindfoot TTC/TC Nail System from Paragon 28, Inc. on Mar 5, 2026 under K253591, a traditional 510(k). The device falls under product code HSB, Rod, Fixation, Intramedullary And Accessories, regulated at 21 CFR 888.3020 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Nov 17, 2025. The decision came 108 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: K261120 (APEX 3D S Diamond Tibia), K262722 (Primal K-Wire (P99-193-1410)), K261121 (Megalodon Dynamic Compression System), K262047 (Grappler Suture Anchor System).

Questions & Answers

What did FDA clear under K253591?

K253591 is the FDA 510(k) for Phantom® Hindfoot TTC/TC Nail System, submitted by Paragon 28, Inc.. FDA's decision date was Mar 5, 2026, under product code HSB (Rod, Fixation, Intramedullary And Accessories).

Who makes the Phantom® Hindfoot TTC/TC Nail System?

Paragon 28, Inc., based in Englewood, CO, is the applicant of record for K253591.

How long did the K253591 review take?

FDA received the submission on Nov 17, 2025 and issued its decision on Mar 5, 2026, 108 days later.

← All decisions in March 2026