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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 / K263407

510(k) cleared

Tempo Plating System

Pace Surgical · Oct 23, 2026 · K263407

FDA cleared the Tempo Plating System from Pace Surgical on Oct 23, 2026 under K263407, a special 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 Sep 25, 2026. The decision came 28 days later, inside the 90 FDA-day goal for a 510(k).

Pace Surgical has 2 other decisions in the tracker over the last 12 months: K261647 (Tempo Plating System; Ultra Compression Screw System), K251555 (Ultra Compression Screw System).

Questions & Answers

What did FDA clear under K263407?

K263407 is the FDA 510(k) for Tempo Plating System, submitted by Pace Surgical. FDA's decision date was Oct 23, 2026, under product code HRS (Plate, Fixation, Bone).

Who makes the Tempo Plating System?

Pace Surgical, based in Malvern, PA, is the applicant of record for K263407.

How long did the K263407 review take?

FDA received the submission on Sep 25, 2026 and issued its decision on Oct 23, 2026, 28 days later.

← All decisions in October 2026

Sources