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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 / K261217

510(k) cleared

AnyPlus II Spinal Fixation System

GS Medical Co., Ltd. · Oct 2, 2026 · K261217

FDA cleared the AnyPlus II Spinal Fixation System from GS Medical Co., Ltd. on Oct 2, 2026 under K261217, a special 510(k). The device falls under product code NKB, Thoracolumbosacral Pedicle Screw System, regulated at 21 CFR 888.3070 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Apr 14, 2026. The decision came 171 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

GS Medical Co., Ltd. has 8 other decisions in the tracker over the last 12 months: K254302 (ECG Analysis Software (AiTiALVSD)), K260250 (QCA 10 Electrocardiograph (QCARD-10); QCA 10W Electrocardiograph (QCARD-10W)), K243223 (Multiple therapy aesthetic treatment device (BHS 202 UNYQUE)), K254260 (The VEGA Cervical Screw System).

Questions & Answers

What did FDA clear under K261217?

K261217 is the FDA 510(k) for AnyPlus II Spinal Fixation System, submitted by GS Medical Co., Ltd.. FDA's decision date was Oct 2, 2026, under product code NKB (Thoracolumbosacral Pedicle Screw System).

Who makes the AnyPlus II Spinal Fixation System?

GS Medical Co., Ltd., based in Cheongju-Si, is the applicant of record for K261217.

How long did the K261217 review take?

FDA received the submission on Apr 14, 2026 and issued its decision on Oct 2, 2026, 171 days later.

← All decisions in October 2026