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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 / August 2026 / K261121

510(k) cleared

Megalodon Dynamic Compression System

Paragon 28, Inc. · Aug 6, 2026 · K261121

FDA cleared the Megalodon Dynamic Compression System from Paragon 28, Inc. on Aug 6, 2026 under K261121, a traditional 510(k). The device falls under product code JDR, Staple, Fixation, Bone, regulated at 21 CFR 888.3030 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Apr 3, 2026. The decision came 125 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)), K262047 (Grappler Suture Anchor System), K253886 (Grappler Suture Anchor PCFD Tether System).

Questions & Answers

What did FDA clear under K261121?

K261121 is the FDA 510(k) for Megalodon Dynamic Compression System, submitted by Paragon 28, Inc.. FDA's decision date was Aug 6, 2026, under product code JDR (Staple, Fixation, Bone).

Who makes the Megalodon Dynamic Compression System?

Paragon 28, Inc., based in Centennial, CO, is the applicant of record for K261121.

How long did the K261121 review take?

FDA received the submission on Apr 3, 2026 and issued its decision on Aug 6, 2026, 125 days later.

← All decisions in August 2026