MBI · Class II · 21 CFR 888.3040

FDA Product Code MBI: Fastener, Fixation, Nondegradable, Soft Tissue

FDA product code MBI covers nondegradable soft tissue fixation fasteners.

These orthopedic implants are used to anchor soft tissue — such as tendons and ligaments — to bone during reconstructive procedures. They are designed to remain permanently in the body without degrading over time.

MBI devices are Class II medical devices, regulated under 21 CFR 888.3040 and reviewed by the FDA Orthopedic panel.

Leading manufacturers include Arthrex, Inc., Smith & Nephew, Inc. and Arthrocare Corp..

599

Total

599

Cleared

100d

Avg days

1995

Since

Declining activity - 57 submissions in the last 2 years vs 77 in the prior period

Review times improving: avg 86d recently vs 102d historically

FDA 510(k) Cleared Fastener, Fixation, Nondegradable, Soft Tissue Devices (Product Code MBI)

599 devices

1–24 of 599

1 2 3 4

Cleared Jul 30, 2026

AIR+ All-Inside Meniscal Repair Device, Curved Up

Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE suture (72205981)

Dione PEEK Screw System

K253130

ZheJiang Decans Medical Devices Co., Ltd.

Orthopedic · 244d

Cleared May 13, 2026

Y-Knotless™ Flex Anchors

Anchor with Fiber Wire and Disposable Inserter

ArthroTAK Tendon Anchor Kit

Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor Line

Arthrex FiberTak Suture Anchor

Grappler Suture Anchor PCFD Tether System

BAAT Medical Products B.V.

Riverpoint Medical, LLC

TeKBrace Knotless Anchor

Aevumed FENIX Suture Anchor

Arthrex Nano FiberTak Suture Anchor

Riverpoint Medical, LLC

Orthopedic · 98d

Cleared Jan 29, 2026

Y-Knotless™ Flex Anchors

Aevumed PROTEKT Suture Anchor

QuadLock™ Fixation System

Arthrex SwiveLock Suture Anchor, 3.5 x 10 mm

Tigon Medical Knotless and Dual Javelin All-Suture Anchors

GMReis Suture Anchors

K252664

GM Dos Reis Industria e Comercio Ltda.

Orthopedic · 74d

1 2 3 4

About Product Code MBI - Regulatory Context

510(k) Submission Activity

599 total 510(k) submissions under product code MBI since 1995, with 599 receiving FDA clearance (average review time: 100 days).

Submission volume has declined in recent years - 57 submissions in the last 24 months compared to 77 in the prior period.

FDA 510(k) Review Time - MBI Product Code

Recent submissions under MBI have taken an average of 86 days to reach a decision - down from 102 days historically, suggesting improved FDA processing for this classification.

MBI devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →

FDA Product Code MBI: Fastener, Fixation, Nondegradable, Soft Tissue

FDA 510(k) Cleared Fastener, Fixation, Nondegradable, Soft Tissue Devices (Product Code MBI)

About Product Code MBI - Regulatory Context

510(k) Submission Activity

FDA 510(k) Review Time - MBI Product Code

Related FDA 510(k) Regulatory Insights