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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 / December 2025 / K250988

510(k) cleared

KLS Martin Pure Pectus System

KLS-Martin L.P. · Dec 11, 2025 · K250988

FDA cleared the KLS Martin Pure Pectus System from KLS-Martin L.P. on Dec 11, 2025 under K250988, a traditional 510(k). The device falls under product code HRS, Plate, 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 Mar 31, 2025. The decision came 255 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

KLS-Martin L.P. has 5 other decisions in the tracker over the last 12 months: K260137 (KLS Martin IPS Oral-Max Implants - MR Conditional; Individual Patient Solutions - Ti (IPS-Ti); Individual Patient Solutions - PEEK (IPS-PEEK); KLS Martin Individual Patient Solutions), K253660 (KLS Martin Pure Pectus System), K254162 (KLS Martin Ixos System), K250865 (KLS Martin IPS Forearm System).

Questions & Answers

What did FDA clear under K250988?

K250988 is the FDA 510(k) for KLS Martin Pure Pectus System, submitted by KLS-Martin L.P.. FDA's decision date was Dec 11, 2025, under product code HRS (Plate, Fixation, Bone).

Who makes the KLS Martin Pure Pectus System?

KLS-Martin L.P., based in Jacksonville, FL, is the applicant of record for K250988.

How long did the K250988 review take?

FDA received the submission on Mar 31, 2025 and issued its decision on Dec 11, 2025, 255 days later.

← All decisions in December 2025