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Apollo is in talks to buy J&J's DePuy Synthes for close to $20B BRAINBox signs Prolight to supply the readers for its concussion blood test Intuitive wins a CE mark for transvaginal surgery with the da Vinci SP Beta Bionics clears the Mint patch pump and cuts 2026 guidance the same day J&J sells the Laminar LAA program it bought for $400M upfront in 2023 GE HealthCare is in talks to buy Sofie Biosciences for about $1B Implicity raises $40M to run cardiac implant monitoring across four vendors Boston Scientific says plants and shipping are fully back 17 days after the cyberattack FDA seeks comment on device tracking and raises the burden estimate by 47,526 hours Apollo is in talks to buy J&J's DePuy Synthes for close to $20B BRAINBox signs Prolight to supply the readers for its concussion blood test Intuitive wins a CE mark for transvaginal surgery with the da Vinci SP Beta Bionics clears the Mint patch pump and cuts 2026 guidance the same day J&J sells the Laminar LAA program it bought for $400M upfront in 2023 GE HealthCare is in talks to buy Sofie Biosciences for about $1B Implicity raises $40M to run cardiac implant monitoring across four vendors Boston Scientific says plants and shipping are fully back 17 days after the cyberattack FDA seeks comment on device tracking and raises the burden estimate by 47,526 hours

The Tracker / September 2026 / K261647

510(k) cleared

Tempo Plating System; Ultra Compression Screw System

Pace Surgical · Sep 3, 2026 · K261647

FDA cleared the Tempo Plating System; Ultra Compression Screw System from Pace Surgical on Sep 3, 2026 under K261647, 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 May 19, 2026. The decision came 107 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Pace Surgical has one other decision in the tracker over the last 12 months: K251555 (Ultra Compression Screw System).

Questions & Answers

What did FDA clear under K261647?

K261647 is the FDA 510(k) for Tempo Plating System; Ultra Compression Screw System, submitted by Pace Surgical. FDA's decision date was Sep 3, 2026, under product code HRS (Plate, Fixation, Bone).

Who makes the Tempo Plating System; Ultra Compression Screw System?

Pace Surgical, based in Malvern, PA, is the applicant of record for K261647.

How long did the K261647 review take?

FDA received the submission on May 19, 2026 and issued its decision on Sep 3, 2026, 107 days later.

← All decisions in September 2026

Sources