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The Tracker / September 2026 / K262975

510(k) cleared

Arthrex Beaming System

Arthrex, Inc. · Sep 25, 2026 · K262975

FDA cleared the Arthrex Beaming System from Arthrex, Inc. on Sep 25, 2026 under K262975, a special 510(k). The device falls under product code HWC, Screw, Fixation, Bone, regulated at 21 CFR 888.3040 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Aug 26, 2026. The decision came 30 days later, inside the 90 FDA-day goal for a 510(k).

Arthrex, Inc. has 8 other decisions in the tracker over the last 12 months: K262618 (Arthrex Spine Compression FT Screw), K262451 (Arthrex DynaNite Staples), K262357 (Arthrex Bioabsorbable PushLock Suture Anchors), K260624 (Arthrex Radial Head Replacement System).

Questions & Answers

What did FDA clear under K262975?

K262975 is the FDA 510(k) for Arthrex Beaming System, submitted by Arthrex, Inc.. FDA's decision date was Sep 25, 2026, under product code HWC (Screw, Fixation, Bone).

Who makes the Arthrex Beaming System?

Arthrex, Inc., based in Naples, FL, is the applicant of record for K262975.

How long did the K262975 review take?

FDA received the submission on Aug 26, 2026 and issued its decision on Sep 25, 2026, 30 days later.

← All decisions in September 2026