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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 / K263421

510(k) cleared

Veritas Shoulder System

restor3d, inc. · Oct 22, 2026 · K263421

FDA cleared the Veritas Shoulder System from restor3d, inc. on Oct 22, 2026 under K263421, a special 510(k). The device falls under product code PHX, Shoulder Prosthesis, Reverse Configuration, regulated at 21 CFR 888.3660 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Sep 25, 2026. The decision came 27 days later, inside the 90 FDA-day goal for a 510(k).

restor3d, inc. has 3 other decisions in the tracker over the last 12 months: K260556 (Veritas Shoulder System), K253992 (Veritas Reverse Total Shoulder System), K252067 (Velora Acetabular System).

Questions & Answers

What did FDA clear under K263421?

K263421 is the FDA 510(k) for Veritas Shoulder System, submitted by restor3d, inc.. FDA's decision date was Oct 22, 2026, under product code PHX (Shoulder Prosthesis, Reverse Configuration).

Who makes the Veritas Shoulder System?

restor3d, inc., based in Durham, NC, is the applicant of record for K263421.

How long did the K263421 review take?

FDA received the submission on Sep 25, 2026 and issued its decision on Oct 22, 2026, 27 days later.

← All decisions in October 2026

Sources