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GE HealthCare clears aortic stenosis and lung scanning software for Vscan Air FDA draws more than 500 comments on its generative AI device framework BRIJ Medical upsizes a $3M raise to $5M for its incision management line Globus Medical bought Synaptive Medical out of receivership in August Philips sets aside 288 million euros for a proposed DOJ settlement over its CPAP recall Rockwell Medical agrees to buy most of Vantive's hemodialysis business Blackstone puts $455M into Boston Scientific's VITALYST heart pump program 1nhaler raises £2.2M to take a cardboard inhaler into the clinic ONWARD Medical sold 88 ARC-EX systems in the third quarter GE HealthCare clears aortic stenosis and lung scanning software for Vscan Air FDA draws more than 500 comments on its generative AI device framework BRIJ Medical upsizes a $3M raise to $5M for its incision management line Globus Medical bought Synaptive Medical out of receivership in August Philips sets aside 288 million euros for a proposed DOJ settlement over its CPAP recall Rockwell Medical agrees to buy most of Vantive's hemodialysis business Blackstone puts $455M into Boston Scientific's VITALYST heart pump program 1nhaler raises £2.2M to take a cardboard inhaler into the clinic ONWARD Medical sold 88 ARC-EX systems in the third quarter

The Tracker / October 2026 / K262779

510(k) cleared

ANTHEM Fracture System

Globus Medical, Inc. · Oct 23, 2026 · K262779

FDA cleared the ANTHEM Fracture System from Globus Medical, Inc. on Oct 23, 2026 under K262779, 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 Aug 5, 2026. The decision came 79 days later, inside the 90 FDA-day goal for a 510(k).

Globus Medical, Inc. has 8 other decisions in the tracker over the last 12 months: K254043 (TRIVANCE Hip Stem), K262251 (ACTIFY Total Knee System, ACTIFY 3D Total Knee System (ACTIFY MC Tibial Insert)), K253739 (SCRIPT Rods, CREO Stabilization System, REVERE® Stabilization System, REVERE® 4.5 Stabilization System, NuVasive Reline System), K253401 (SCRIPT Implant System).

Questions & Answers

What did FDA clear under K262779?

K262779 is the FDA 510(k) for ANTHEM Fracture System, submitted by Globus Medical, Inc.. FDA's decision date was Oct 23, 2026, under product code HRS (Plate, Fixation, Bone).

Who makes the ANTHEM Fracture System?

Globus Medical, Inc., based in Audubon, PA, is the applicant of record for K262779.

How long did the K262779 review take?

FDA received the submission on Aug 5, 2026 and issued its decision on Oct 23, 2026, 79 days later.

← All decisions in October 2026