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., Innovasive Devices, Inc. and Smith & Nephew, Inc..
607
Total
607
Cleared
100d
Avg days
1995
Since
Stable submission activity - 62 submissions in the last 2 years
Consistent review times:
87d avg (recent)
FDA 510(k) Cleared Fastener, Fixation, Nondegradable, Soft Tissue Devices (Product Code MBI)
607 devices
Cleared
Oct 27, 2026
Arthrex FiberButton
Arthrex, Inc.
Orthopedic
28d
Cleared
Oct 23, 2026
Q-FIX KNOTLESS All-Suture Anchor, 1.8mm, with one ULTRABRAID Suture, Blue
Smith & Nephew, Inc.
Orthopedic
30d
Cleared
Oct 21, 2026
TeKBrace Knotless Anchor
Theramicro
Orthopedic
28d
Cleared
Sep 17, 2026
Integrity Retractable Implant Inserter (6000127)
Anika Therapeutics, Inc.
Orthopedic
105d
Cleared
Sep 02, 2026
Aevumed SUPERCYNCH™ Button System
Aevumed, Inc.
Orthopedic
345d
Cleared
Sep 02, 2026
ArthroTAK Tendon Anchor Kit
ArthroTAK, LLC
Orthopedic
26d
Cleared
Aug 27, 2026
Iconix Knotless T
Riverpoint Medical
Orthopedic
28d
Cleared
Aug 03, 2026
Grappler Suture Anchor System
Paragon 28, Inc.
Orthopedic
46d
Cleared
Jul 30, 2026
AIR+ All-Inside Meniscal Repair Device, Curved Up
Stryker Endoscopy
Orthopedic
20d
Cleared
Jul 29, 2026
Suture Button Repair System
Skeletal Dynamics, Inc.
Orthopedic
61d
Cleared
Jul 20, 2026
Thunderbolt System
Responsive Arthroscopy, Inc.
Orthopedic
63d
Cleared
Jul 09, 2026
Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE suture (72205981)
Smith & Nephew, Inc.
Orthopedic
28d
Cleared
Jun 26, 2026
Arthrex FiberButton
Arthrex, Inc.
Orthopedic
172d
Cleared
May 27, 2026
Dione PEEK Screw System
ZheJiang Decans Medical Devices Co., Ltd.
Orthopedic
244d
Cleared
May 13, 2026
Y-Knotless™ Flex Anchors
Conmed Corporation
Orthopedic
16d
Cleared
May 06, 2026
Anchor with Fiber Wire and Disposable Inserter
Ortobio S.A.
Orthopedic
229d
Cleared
May 01, 2026
ArthroTAK Tendon Anchor Kit
ArthroTAK, LLC
Orthopedic
254d
Cleared
Apr 21, 2026
Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor Line
Tigon Medical
Orthopedic
33d
Cleared
Mar 20, 2026
Arthrex FiberTak Suture Anchor
Arthrex, Inc.
Orthopedic
29d
Cleared
Mar 17, 2026
Grappler Suture Anchor PCFD Tether System
Paragon 28, Inc.
Orthopedic
103d
Cleared
Mar 16, 2026
SINEFIX
BAAT Medical Products B.V.
Orthopedic
83d
Cleared
Mar 12, 2026
Trax EX Anchor
Trax Surgical, Inc.
Orthopedic
276d
Cleared
Mar 11, 2026
Strut Suture
Riverpoint Medical, LLC
Orthopedic
110d
Cleared
Mar 09, 2026
FiberTape Button
Arthrex, Inc.
Orthopedic
28d
About Product Code MBI - Regulatory Context
510(k) Submission Activity
607 total 510(k) submissions under product code MBI since 1995, with 607 receiving FDA clearance (average review time: 100 days).
Submission volume has remained relatively stable over the observed period, with 62 submissions in the last 24 months.
FDA 510(k) Review Time - MBI Product Code
FDA review times for MBI submissions have been consistent, averaging 87 days recently vs 102 days historically.
MBI devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →