FDA.report

510(k) K251680

Device
Biosteon® Screw
Applicant
Biocomposites, Ltd.
510(k) number
K251680
Product code
MAI
Decision
Substantially Equivalent (SESE)
Decision date
2026-02-17
Date received
2025-05-30
Regulation
888.3030
Classification name
Fastener, Fixation, Biodegradable, Soft Tissue
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Ciara Airey
Address
Keele Science Park Keele GB ST5 5NL ST5 5NL

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Other 510(k) Records For Product Code MAI

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K260294SF Push-in AnchorSurgical Fusion Technologies GmbH2026-03-27
K254055OSSIOfiber® Suture AnchorOSSIO , Ltd.2026-02-24
K252946BioBrace® Extra-Articular Ligament Augmentation KitConmed Corporation2025-10-15
K252022OSSIOfiber® Interference ScrewOSSIO , Ltd.2025-08-19
K251309OSSIOfiber® Suture AnchorOSSIO , Ltd.2025-05-27
K250544Knotilus+ Biocomposite Knotless AnchorStryker Endoscopy2025-05-23
K250528Stryker AlphaVent™ Knotless SP Biocomposite AnchorStryker Endoscopy2025-05-21
K243760OSSIOfiber® Suture Anchor 2.5-3.5 mmOSSIO , Ltd.2025-04-03
K250526Arthrex 4.75 mm Double Loaded Knotless Corkscrew Suture AnchorArthrex, Inc.2025-03-14
K243790GRYPHON™ X Anchor; HEALIX TRANSTEND™ AnchorDepuy Mitek2025-02-05
K243467Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching)Osteonic Co., Ltd.2024-12-03
K241010HEALIX ADVANCE Knotless anchors; HEALIX ADVANCE Self-Punching anchorsDepuy Mitek2024-09-11
K241912BIOCHARGENanofiber Solutions, LLC2024-07-29
K233971Arthrex AlloSync PushLock Suture AnchorArthrex, Inc.2024-06-04
K240288SF Push- in AnchorSurgical Fusion Technologies GmbH2024-04-01