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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 / K263352

510(k) cleared

TeKBrace Knotless Anchor

TheraMicro · Oct 21, 2026 · K263352

FDA cleared the TeKBrace Knotless Anchor from TheraMicro on Oct 21, 2026 under K263352, a special 510(k). The device falls under product code MBI, Fastener, Fixation, Nondegradable, Soft Tissue, regulated at 21 CFR 888.3040 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Sep 23, 2026. The decision came 28 days later, inside the 90 FDA-day goal for a 510(k).

TheraMicro has 3 other decisions in the tracker over the last 12 months: K262729 (TeKBrace Solo Soft Tissue Reinforcement Device), K261621 (TekBrace Solo Soft Tissue Reinforcement Device), K253538 (TeKBrace Knotless Anchor).

Questions & Answers

What did FDA clear under K263352?

K263352 is the FDA 510(k) for TeKBrace Knotless Anchor, submitted by TheraMicro. FDA's decision date was Oct 21, 2026, under product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue).

Who makes the TeKBrace Knotless Anchor?

TheraMicro, based in Cordova, TN, is the applicant of record for K263352.

How long did the K263352 review take?

FDA received the submission on Sep 23, 2026 and issued its decision on Oct 21, 2026, 28 days later.

← All decisions in October 2026

Sources