510(k) K253931

Arthrex Bioabsorbable PushLock Suture Anchors by Arthrex, Inc. — Product Code MAI

K253931 is an FDA 510(k) premarket notification submitted by Arthrex, Inc. for the device "Arthrex Bioabsorbable PushLock Suture Anchors". The FDA issued a decision of Substantially Equivalent on May 28, 2026. The device falls under product code MAI (Fastener, Fixation, Biodegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3030. Arthrex, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 28, 2026
Date Received
December 9, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fastener, Fixation, Biodegradable, Soft Tissue
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type