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..
220
Total
220
Cleared
108d
Avg days
1994
Since
220 devices
Cleared
Nov 27, 2017
HEALIX ADVANCE KNOTLESS Anchor
Medos International SARL
Orthopedic
227d
Cleared
Aug 29, 2017
CrossFT™ Knotless Biocomposite Suture Anchor with Disposable Driver
Conmed Corporation
Orthopedic
90d
Cleared
May 18, 2017
HEALIX ADVANCE Anchor with PERMATAPE Suture
Medos International SARL
Orthopedic
77d
Cleared
May 04, 2017
Arthrex SwiveLock Anchors
Arthrex, Inc.
Orthopedic
16d
Cleared
Mar 17, 2017
CrossFT Knotless Biocomposite Suture Anchor with Disposable Driver
Conmed Corporation
Orthopedic
24d
Cleared
Jul 19, 2016
INTRAFIX(TM) Advance Tibial Fastener System
Medos International SARL
Orthopedic
118d
Cleared
Mar 24, 2016
Arthrex SwiveLock Anchors
Arthrex, Inc.
Orthopedic
310d
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
Smith & Nephew, Inc.
Orthopedic
95d
Cleared
May 21, 2015
Milagro / Milagro Advance Interference Screw
Depuy Mitek, A Johnson & Johnson Company
Orthopedic
149d
Cleared
Feb 04, 2015
ACL SMART System
Smith & Nephew, Inc.
Orthopedic
92d
Cleared
Jan 13, 2015
BIOSURE REGENESORB interference Screw
Smith & Nephew, Inc.
Orthopedic
95d
Cleared
Dec 18, 2014
ARTHREX SUTURETAK SUTURE ANCHORS
Arthrex, Inc.
Orthopedic
259d
Cleared
Jun 10, 2014
GRYPHON BR ANCHOR WITH PERMACORD, GRYPHON BR DS ANCHOR WITH PERMACORD,GRYPHON PEEK ANCHOR WITH PERMACORD, GRYPHON PEEK
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
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
Depuy Mitek, A Johnson & Johnson Company
Orthopedic
110d
Cleared
Jul 25, 2013
HEALIX ADVANCE KNOTLESS BR ANCHOR (6.5MM)
Depuy Mitek, A Johnson & Johnson Company
Orthopedic
27d
Cleared
May 24, 2013
HEALIX ADVANCE KNOTLESS BR ANCHOR
Depuy Mitek, A Johnson & Johnson Company
Orthopedic
51d
Cleared
May 13, 2013
TORNIER INSITE FT BIOCOMPOSITE SUTURE ANCHOR
Tornier, Inc.
Orthopedic
257d
Cleared
Apr 11, 2013
HEALICOIL SUTURE ANCHOR WITH REGENESORB
Smith & Nephew, Inc.
Orthopedic
160d
Cleared
Dec 13, 2012
MILAGRO INTERFERENCE SCREWS
Depuy Mitek, A Johnson & Johnson Company
Orthopedic
85d
Cleared
Apr 24, 2012
MILAGRO INTERFERENCE SCREWS
Depuy Mitek, A Johnson & Johnson Company
Orthopedic
56d
Cleared
Mar 20, 2012
BIOBOLT
Arthrex, Inc.
Orthopedic
26d
Cleared
Dec 20, 2011
HEALIX KNOTLESS ANCHOR
Depuy Mitek, A Johnson & Johnson Company
Orthopedic
20d
Cleared
Dec 15, 2011
ARTHREX BIOCOMPOSITE TRANSFIX
Arthrex, Inc.
Orthopedic
150d