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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 / K262769

510(k) cleared

Permatage XT Settable Nonabsorbable Hemostatic Bone Putty (OS-PER-1001XT)

Orthocon, Inc. · Sep 3, 2026 · K262769

FDA cleared the Permatage XT Settable Nonabsorbable Hemostatic Bone Putty (OS-PER-1001XT) from Orthocon, Inc. on Sep 3, 2026 under K262769, a special 510(k). The device falls under product code MTJ, Wax, Bone as a Class U device. The review panel was Unknown.

FDA logged the submission as received on Aug 4, 2026. The decision came 30 days later, inside the 90 FDA-day goal for a 510(k).

Orthocon, Inc. has 5 other decisions in the tracker over the last 12 months: K261265 (Permatage XT Settable Bone Putty), K261439 (Permatage Flowable, Settable Hemostatic Bone Paste), K253447 (Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover)), K253732 (Permatage Flowable, Settable Bone Paste).

Questions & Answers

What did FDA clear under K262769?

K262769 is the FDA 510(k) for Permatage XT Settable Nonabsorbable Hemostatic Bone Putty (OS-PER-1001XT), submitted by Orthocon, Inc.. FDA's decision date was Sep 3, 2026, under product code MTJ (Wax, Bone).

Who makes the Permatage XT Settable Nonabsorbable Hemostatic Bone Putty (OS-PER-1001XT)?

Orthocon, Inc., based in Stamford, CT, is the applicant of record for K262769.

How long did the K262769 review take?

FDA received the submission on Aug 4, 2026 and issued its decision on Sep 3, 2026, 30 days later.

← All decisions in September 2026