MAI · Class II · 21 CFR 888.3030

FDA Product Code MAI: Fastener, Fixation, Biodegradable, Soft Tissue

Biodegradable fixation eliminates the need for hardware removal surgery in soft tissue repair. FDA product code MAI covers biodegradable soft tissue fixation fasteners.

These implants anchor tendons and ligaments to bone during reconstructive procedures and gradually resorb as the tissue heals, leaving no permanent implant in the body. They are used in ACL reconstruction, rotator cuff repair, and other sports medicine procedures.

MAI devices are Class II medical devices, regulated under 21 CFR 888.3030 and reviewed by the FDA Orthopedic panel.

Leading manufacturers include Arthrex, Inc., Depuy Mitek, A Johnson & Johnson Company and Linvatec Corp..

221
Total
221
Cleared
108d
Avg days
1994
Since
221 devices
73–96 of 221
Cleared Jan 16, 2018
Arthrex PushLock
K173240
Arthrex, Inc.
Orthopedic · 103d
Cleared Nov 30, 2017
FIXIT Threaded Anchor System
K170868
S.B.M Sas Science For Bio Materials
Orthopedic · 252d
Cleared Nov 27, 2017
HEALIX ADVANCE KNOTLESS Anchor
K171114
Medos International SARL
Orthopedic · 227d
Cleared Aug 29, 2017
CrossFT™ Knotless Biocomposite Suture Anchor with Disposable Driver
K171592
Conmed Corporation
Orthopedic · 90d
Cleared Aug 24, 2017
Fixone Biocomposite Anchor
K171299
Aju Pharm Co., Ltd.
Orthopedic · 113d
Cleared May 18, 2017
HEALIX ADVANCE Anchor with PERMATAPE Suture
K170639
Medos International SARL
Orthopedic · 77d
Cleared May 05, 2017
Nanova Screw-In Suture Anchor, Nanova Push-In Suture Anchor
K163672
Nanova Biomaterials, Inc.
Orthopedic · 129d
Cleared May 04, 2017
Arthrex SwiveLock Anchors
K171141
Arthrex, Inc.
Orthopedic · 16d
Cleared Mar 17, 2017
CrossFT Knotless Biocomposite Suture Anchor with Disposable Driver
K170501
Conmed Corporation
Orthopedic · 24d
Cleared Mar 13, 2017
ZipE Knotless Tissue Repair and Attachment Devices
K162429
Ziptek, LLC
Orthopedic · 195d
Cleared Nov 03, 2016
Nanova Interference Screw
K161174
Nanova Biomaterials, Inc.
Orthopedic · 191d
Cleared Jul 19, 2016
INTRAFIX(TM) Advance Tibial Fastener System
K160804
Medos International SARL
Orthopedic · 118d
Cleared Mar 24, 2016
Arthrex SwiveLock Anchors
K151342
Arthrex, Inc.
Orthopedic · 310d
Cleared Oct 06, 2015
Healix BR Anchor, Healix PEEK Anchor, Healix Transtend, Gryphon T and P BR Anchor, Gryphon PEEK Anchor, VersaLok Anchor, Bioknotless BR Anchor, Lupine BR Anchor, PanaLok Anchor,PanaLok Anchor with Orthocord, PanaLok RC QuickAnchor Plus
K150209
Depuy Mitek, A Johnson and Johnson Company
Orthopedic · 249d
Cleared Jul 28, 2015
Smith and Nephew Suture Anchors - 5.0mm Absorbable Polymer Anchor, Smith and Nephew Suture Anchors - TAG Bioraptor Suture Anchor 7209317, 7209318, Smith and Nephew Suture Anchors - Bioraptor 2.3 PK Suture Anchor, Smith and Nephew Suture Anchors - Osteoraptor Suture Anchor, Smith and Nephew Suture Anchors - Twinfix Ultra HA Suture Anchor, Smith and Nephew Suture Anchors - OSTEORAPTOR Curved Suture Anchors, Smith and Nephew Suture Anchors - Ultra Fast-Fix Meniscal Repair System, Ultra Fa
K151105
Smith & Nephew, Inc.
Orthopedic · 95d
Cleared May 21, 2015
Milagro / Milagro Advance Interference Screw
K143660
Depuy Mitek, A Johnson & Johnson Company
Orthopedic · 149d
Cleared Feb 04, 2015
ACL SMART System
K143172
Smith & Nephew, Inc.
Orthopedic · 92d
Cleared Jan 13, 2015
BIOSURE REGENESORB interference Screw
K142948
Smith & Nephew, Inc.
Orthopedic · 95d
Cleared Dec 18, 2014
ARTHREX SUTURETAK SUTURE ANCHORS
K140855
Arthrex, Inc.
Orthopedic · 259d
Cleared Jul 08, 2014
GRYPHON BR ANCHOR W/PROKNOT TECHNOLOGY,GRYPHON PEEK ANCHOR W/ PROKNOT TECHNOLOGY
K140643
Depuy Mitek, A Johnson and Johnson Company
Orthopedic · 118d
Cleared Jun 10, 2014
GRYPHON BR ANCHOR WITH PERMACORD, GRYPHON BR DS ANCHOR WITH PERMACORD,GRYPHON PEEK ANCHOR WITH PERMACORD, GRYPHON PEEK
K141259
Depuy Mitek, A Johnson & Johnson Company
Orthopedic · 26d
Cleared Feb 04, 2014
4.5MM HEALIX ADVANCE BR ANCHOR, WITH 2 OR 3 STRANDS OF #2 PERMACORD SUTURE, 5.5MM HEALIX ADVANCE BR ANCHOR, WITH 2 OR 3
K133794
Depuy Mitek, A Johnson & Johnson Company
Orthopedic · 53d
Cleared Nov 05, 2013
GRYPHON BR ANCHOR W/ PROKNOT TECHNOLOGY, GRYPHON BR ANCHOR W/ PROKNOT TECHNOLOGY - HIP, GRYPHON PEEK ANCHOR W/ PROKNOT T
K132241
Depuy Mitek, A Johnson & Johnson Company
Orthopedic · 110d
Cleared Aug 28, 2013
BIORETEC ACTIVASCREW INTERFERENCE
K130716
Bioretec, Ltd.
Orthopedic · 166d