Sinefix

FDA 510(k) K254176 · BAAT Medical Products B.V.

Substantially Equivalent

510(k) numberK254176

Submission

Device name
Sinefix
Applicant
BAAT Medical Products B.V.
Hengelo, NL
Received
December 23, 2025
Decision date
March 16, 2026
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
MBI – Fastener, Fixation, Nondegradable, Soft Tissue
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3040
Specialty
Orthopedic
Implant
Yes

Other 510(k)s with product code MBI

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K262677Iconix Knotless TMBI · Special Riverpoint Medical08/27/2026SE
K262047Grappler Suture Anchor SystemMBI · Special Paragon 28, Inc.08/03/2026SE
K262369AIR+ All-Inside Meniscal Repair Device, Curved Up;AIR+ All-Inside Meniscal Repair…MBI · Special Stryker Endoscopy07/30/2026SE
K261770Suture Button Repair SystemMBI · Traditional Skeletal Dynamics, Inc.07/29/2026SE
K261632Thunderbolt SystemMBI · Special Responsive Arthroscopy, Inc.07/20/2026SE
K261968Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE…MBI · Special Smith & Nephew, Inc.07/09/2026SE
K260018Arthrex FiberButtonMBI · Traditional Arthrex, Inc.06/26/2026SE
K253130Dione PEEK Screw SystemMBI · Traditional ZheJiang Decans Medical Devices Co., Ltd.05/27/2026SE

More from ZheJiang Decans Medical Devices Co., Ltd.

510(k)DeviceDecision
K251961SDS Growing RodPGM · Traditional 01/15/2026SE
K220966SinefixMBI · Traditional 03/08/2023SE
K211474Kleiner KG2 SystemMAX · Traditional 09/14/2021SE
K201830ANSER Clavicle PinHSB · Traditional 08/27/2020SE

Questions and answers

When was Sinefix cleared by the FDA?

Sinefix (K254176) received a 510(k) decision of Substantially Equivalent on March 16, 2026, 83 days after the submission was received.

What is the product code of K254176?

The FDA product code is MBI – Fastener, Fixation, Nondegradable, Soft Tissue, a Class II (moderate risk) device regulated under 21 CFR 888.3040.