SF Push-in Anchor

FDA 510(k) K260294 · Surgical Fusion Technologies GmbH

Substantially Equivalent

510(k) numberK260294

Submission

Device name
SF Push-in Anchor
Applicant
Surgical Fusion Technologies GmbH
Schlieren, CH
Received
January 29, 2026
Decision date
March 27, 2026
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
MAI – Fastener, Fixation, Biodegradable, Soft Tissue
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3030
Specialty
Orthopedic
Implant
Yes

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K262357Arthrex Bioabsorbable PushLock Suture AnchorsMAI · Special Arthrex, Inc.08/07/2026SE
K253931Arthrex Bioabsorbable PushLock Suture AnchorsMAI · Traditional Arthrex, Inc.05/28/2026SE
K254055OSSIOfiber® Suture AnchorMAI · Traditional OSSIO , Ltd.02/24/2026SE
K251680Biosteon® ScrewMAI · Traditional Biocomposites, Ltd.02/17/2026SE
K252946BioBrace® Extra-Articular Ligament Augmentation KitMAI · Special Conmed Corporation10/15/2025SE
K252022OSSIOfiber® Interference ScrewMAI · Traditional OSSIO , Ltd.08/19/2025SE
K251309OSSIOfiber® Suture AnchorMAI · Special OSSIO , Ltd.05/27/2025SE
K250544Knotilus+ Biocomposite Knotless AnchorMAI · Traditional Stryker Endoscopy05/23/2025SE
K250528Stryker AlphaVent™ Knotless SP Biocomposite AnchorMAI · Traditional Stryker Endoscopy05/21/2025SE
K243760OSSIOfiber® Suture Anchor 2.5-3.5 mmMAI · Traditional OSSIO , Ltd.04/03/2025SE

More from OSSIO , Ltd.

510(k)DeviceDecision
K240288SF Push- in AnchorMAI · Traditional 04/01/2024SE

Questions and answers

When was SF Push-in Anchor cleared by the FDA?

SF Push-in Anchor (K260294) received a 510(k) decision of Substantially Equivalent on March 27, 2026, 57 days after the submission was received.

What is the product code of K260294?

The FDA product code is MAI – Fastener, Fixation, Biodegradable, Soft Tissue, a Class II (moderate risk) device regulated under 21 CFR 888.3030.