WasherCap Mini Fixation System (Model 45)

Q: What is the product code of K243712?

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

FDA 510(k) K243712 · Abanza Tecnomed S.L

Substantially Equivalent

510(k) numberK243712

Submission

Device name: WasherCap Mini Fixation System (Model 45)
Applicant: Abanza Tecnomed S.L
Mutilva, ES
Received: December 2, 2024
Decision date: January 30, 2025
Decision: Substantially Equivalent (SESE)
Type: Traditional 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

510(k)	Device	Applicant	Decision
K262809	ArthroTAK Tendon Anchor KitMBI · Special	ArthroTAK, LLC	09/02/2026SE
K253065	Aevumed SUPERCYNCH Button SystemMBI · Traditional	Aevumed, Inc.	09/02/2026SE
K262677	Iconix Knotless TMBI · Special	Riverpoint Medical	08/27/2026SE
K262047	Grappler Suture Anchor SystemMBI · Special	Paragon 28, Inc.	08/03/2026SE
K262369	AIR+ All-Inside Meniscal Repair Device, Curved Up;AIR+ All-Inside Meniscal Repair…MBI · Special	Stryker Endoscopy	07/30/2026SE
K261770	Suture Button Repair SystemMBI · Traditional	Skeletal Dynamics, Inc.	07/29/2026SE
K261632	Thunderbolt SystemMBI · Special	Responsive Arthroscopy, Inc.	07/20/2026SE
K261968	Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE…MBI · Special	Smith & Nephew, Inc.	07/09/2026SE
K260018	Arthrex FiberButtonMBI · Traditional	Arthrex, Inc.	06/26/2026SE
K253130	Dione PEEK Screw SystemMBI · Traditional	ZheJiang Decans Medical Devices Co., Ltd.	05/27/2026SE

More from ZheJiang Decans Medical Devices Co., Ltd.

510(k)	Device	Decision
K253618	QuadLock Fixation SystemMBI · Traditional	01/06/2026SE
K250238	WasherCap Fixation SystemMBI · Special	02/25/2025SE
K212197	WasherCap Fixation SystemMBI · Traditional	09/22/2022SE

Questions and answers

When was WasherCap Mini Fixation System (Model 45) cleared by the FDA?

WasherCap Mini Fixation System (Model 45) (K243712) received a 510(k) decision of Substantially Equivalent on January 30, 2025, 59 days after the submission was received.

What is the product code of K243712?

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

WasherCap Mini Fixation System (Model 45)