OSSIOfiber® Staple

FDA 510(k) K212594 · OSSIO , Ltd.

Substantially Equivalent

510(k) numberK212594

Submission

Device name
OSSIOfiber® Staple
Applicant
OSSIO , Ltd.
Caesarea, IL
Received
August 16, 2021
Decision date
January 21, 2022
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
MNU – Staple, Absorbable
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3030
Specialty
Orthopedic
Implant
Yes

Other 510(k)s with product code MNU

510(k)DeviceApplicantDecision
K241932OSSIOfiber® Compression StapleMNU · Traditional OSSIO , Ltd.08/28/2024SE
K233302OSSIOfiber® Compression StapleMNU · Traditional OSSIO , Ltd.11/16/2023SE
K011172Arthrex Bio-TransfixMNU · Traditional Arthrex, Inc.06/19/2001SE

More from Arthrex, Inc.

510(k)DeviceDecision
K254077OSSIOfiber® Threaded Trimmable Fixation NailHWC · Traditional 05/01/2026SE
K254055OSSIOfiber® Suture AnchorMAI · Traditional 02/24/2026SE
K252022OSSIOfiber® Interference ScrewMAI · Traditional 08/19/2025SE
K251309OSSIOfiber® Suture AnchorMAI · Special 05/27/2025SE
K243760OSSIOfiber® Suture Anchor 2.5-3.5 mmMAI · Traditional 04/03/2025SE
K241932OSSIOfiber® Compression StapleMNU · Traditional 08/28/2024SE
K241277OSSIOfiber® Threaded Trimmable Fixation NailHWC · Traditional 07/03/2024SE
K233198OSSIOfiber® Threaded Trimmable Fixation NailsHWC · Traditional 03/08/2024SE
K231272OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable…HTY · Traditional 12/01/2023SE
K233302OSSIOfiber® Compression StapleMNU · Traditional 11/16/2023SE

Questions and answers

When was OSSIOfiber® Staple cleared by the FDA?

OSSIOfiber® Staple (K212594) received a 510(k) decision of Substantially Equivalent on January 21, 2022, 158 days after the submission was received.

What is the product code of K212594?

The FDA product code is MNU – Staple, Absorbable, a Class II (moderate risk) device regulated under 21 CFR 888.3030.