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MAI — Fastener, Fixation, Biodegradable, Soft Tissue Class II

FDA Device Classification

Classification Details

Product Code
MAI
Device Class
Class II
Regulation Number
888.3030
Submission Type
Review Panel
OR
Medical Specialty
Orthopedic
Implant
Yes

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K254055ossioOSSIOfiber® Suture AnchorFebruary 24, 2026
K251680biocompositesBiosteon® ScrewFebruary 17, 2026
K252946conmed corporationBioBrace® Extra-Articular Ligament Augmentation KitOctober 15, 2025
K252022ossioOSSIOfiber® Interference ScrewAugust 19, 2025
K251309ossioOSSIOfiber® Suture AnchorMay 27, 2025
K250544stryker endoscopyKnotilus+ Biocomposite Knotless AnchorMay 23, 2025
K250528stryker endoscopyStryker AlphaVent™ Knotless SP Biocomposite AnchorMay 21, 2025
K243760ossioOSSIOfiber® Suture Anchor 2.5-3.5 mmApril 3, 2025
K250526arthrexArthrex 4.75 mm Double Loaded Knotless Corkscrew Suture AnchorMarch 14, 2025
K243790depuy mitekGRYPHON™ X Anchor; HEALIX TRANSTEND™ AnchorFebruary 5, 2025
K243467osteonic coFix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching)December 3, 2024
K241010depuy mitekHEALIX ADVANCE Knotless anchors; HEALIX ADVANCE Self-Punching anchorsSeptember 11, 2024
K241912nanofiber solutionsBIOCHARGEJuly 29, 2024
K233971arthrexArthrex AlloSync PushLock Suture AnchorJune 4, 2024
K240288surgical fusion technologiesSF Push- in AnchorApril 1, 2024
K240441depuy mitekMILAGRO Interference Screw; MILAGRO ADVANCE Interference ScrewMarch 15, 2024
K240090conmed corporationArgo Knotless GENESYS AnchorMarch 5, 2024
K232513parcus medicalX-Twist Biocomposite Suture AnchorSeptember 18, 2023
K231787science and bio materials (s.b.m.)ecoFIX®July 26, 2023
K231641nanofiber solutionsRotium Bioresorbable WickJuly 5, 2023