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
97–120 of 221
Cleared Jul 25, 2013
HEALIX ADVANCE KNOTLESS BR ANCHOR (6.5MM)
K131974
Depuy Mitek, A Johnson & Johnson Company
Orthopedic · 27d
Cleared May 24, 2013
HEALIX ADVANCE KNOTLESS BR ANCHOR
K130917
Depuy Mitek, A Johnson & Johnson Company
Orthopedic · 51d
Cleared May 13, 2013
TORNIER INSITE FT BIOCOMPOSITE SUTURE ANCHOR
K122635
Tornier, Inc.
Orthopedic · 257d
Cleared Apr 11, 2013
HEALICOIL SUTURE ANCHOR WITH REGENESORB
K123393
Smith & Nephew, Inc.
Orthopedic · 160d
Cleared Dec 13, 2012
MILAGRO INTERFERENCE SCREWS
K122869
Depuy Mitek, A Johnson & Johnson Company
Orthopedic · 85d
Cleared Oct 03, 2012
LIGAFIX INTERFERENCE SCREW
K122228
Sbm Sciences For Bio Materials
Orthopedic · 69d
Cleared Aug 22, 2012
GENESYS PRESSFT SUTURE ANCHOR
K121890
Linvatec Corporation D/B/A Conmed Linvatec
Orthopedic · 55d
Cleared Apr 24, 2012
MILAGRO INTERFERENCE SCREWS
K120589
Depuy Mitek, A Johnson & Johnson Company
Orthopedic · 56d
Cleared Mar 20, 2012
BIOBOLT
K120540
Arthrex, Inc.
Orthopedic · 26d
Cleared Feb 29, 2012
HEALIX ADVANCE BR ANCHOR
K120078
Depuy Mitek Inc., Johnson and Johnson Company
Orthopedic · 50d
Cleared Dec 20, 2011
HEALIX KNOTLESS ANCHOR
K113534
Depuy Mitek, A Johnson & Johnson Company
Orthopedic · 20d
Cleared Dec 15, 2011
ARTHREX BIOCOMPOSITE TRANSFIX
K112040
Arthrex, Inc.
Orthopedic · 150d
Cleared Oct 25, 2011
HEALIX KNOTLESS(TM) ANCHOR
K112249
Depuy Mitek, A Johnson & Johnson Company
Orthopedic · 81d
Cleared Jul 21, 2011
DEPUY MITEK MILAGRO INTERFERENCE SCREW MODEL 231803, 231804, 231807, 231809
K103831
Depuy Mitek, A Johnson & Johnson Company
Orthopedic · 203d
Cleared Mar 31, 2011
ARTHREX BIOCOMPOSITE SUTURETAK
K110660
Arthrex, Inc.
Orthopedic · 24d
Cleared Feb 03, 2011
OSTEORAPTOR CURVED 2.3 SUTURE ANCHORS
K103309
Smith & Nephew Endoscopy, Inc.
Orthopedic · 85d
Cleared Jan 27, 2011
OSTEORAPTOR II SUTURE ANCHOR OR TO BE DETERMINED MODEL: 72202764 72202765 72202766 72202767 72202768 72202769 72202770
K101459
Smith & Nephew, Inc.
Orthopedic · 246d
Cleared Jan 07, 2011
ARTHREX SWIVELOCK ANCHORS
K101823
Arthrex, Inc.
Orthopedic · 191d
Cleared Oct 22, 2010
ARTHREX PUSHLOCK ANCHORS
K101679
Arthrex, Inc.
Orthopedic · 129d
Cleared Aug 26, 2010
CROSSFT OC SUTURE ANCHOR MODE CFC-4502, CFC-5502, CFC-6502, CFC-4503, CFC-5503, CFC-6503
K101100
Conmed Linvatec
Orthopedic · 128d
Cleared Apr 30, 2010
GRYPHON T BR DS ANCHOR W/ORTHOCORD, GRYPHON T BR ANCHOR W /ORTHOCORD, GRYPHON P BR DS ANCHOR W/ORTHOCORD, GRYPHON P BR A
K100012
Depuy Mitek, A Johnson & Johnson Company
Orthopedic · 116d
Cleared Apr 01, 2010
SMITH & NEPHEW TWINFIX ULTRA HA SUTURE ANCHOR
K093844
Smith & Nephew, Inc.
Orthopedic · 107d
Cleared Oct 19, 2009
CONMED LINVATEC PRESTO PRELOADED WITH ONE OR TWO #2 HI-FI SUTURES
K092898
Conmed Linvatec
Orthopedic · 28d
Cleared Aug 28, 2009
ARTHREX BIO-COMPOSITE SUTURETAK ANCHORS
K091844
Arthrex, Inc.
Orthopedic · 67d