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..

220
Total
220
Cleared
108d
Avg days
1994
Since
220 devices
97–120 of 220
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 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 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 Aug 28, 2009
ARTHREX BIO-COMPOSITE SUTURETAK ANCHORS
K091844
Arthrex, Inc.
Orthopedic · 67d
Cleared Aug 07, 2009
RIGIDFIX BIOCRYL 2.7MM BTB (210815), FEMORAL 3.3MM ST (210816), AND TIBIAL 3.3MM ST (210817) CROSS PIN KITS
K091041
Depuy Mitek, A Johnson & Johnson Company
Orthopedic · 116d
Cleared Jun 22, 2009
CONMED LINVATEC BIO MINI-REVO SUTURE ANCHOR, MODEL C6170CR
K090835
Linvatec Corp.
Orthopedic · 87d
Cleared Apr 10, 2009
CONMED LINVATEC PALADIN, PRELOADED WITH TWO #2 HI-FI SUTURES
K090186
Linvatec Corp.
Orthopedic · 74d
Cleared Apr 03, 2009
RIGIDFIX BIOCRYL CROSS PIN KITS
K090669
Depuy Mitek, A Johnson & Johnson Company
Orthopedic · 21d
Cleared Mar 11, 2009
GRYPHON P BR DS ANCHOR W/ORTHOCORD,GRYPHON P BR ANCHOR W/ORTHOCORD, MODEL 210813,210814
K090124
Depuy Mitek, A Johnson & Johnson Company
Orthopedic · 49d
Cleared Feb 12, 2009
TORNIER, INC., INSITE SUTURE ANCHORS
K083268
Tornier, Inc.
Orthopedic · 99d
Cleared Jan 23, 2009
ARTHREX BIO-COMPOSITE SUTURE ANCHORS: ARTHREX BIO-COMPOSITE PUSHLOCK, BIO-COMPOSITE TAK AND BIO-COMPOSITE CORKSCREW
K082810
Arthrex, Inc.
Orthopedic · 121d
Cleared Dec 30, 2008
ARTHREX MENISCAL DART, ARTHREX MENISCAL DARTSTICK, ARTHREX CHONDRAL DART
K082999
Arthrex, Inc.
Orthopedic · 83d
Cleared Jan 17, 2008
ARTHREX PROSTOP PLUS ARTHROEREISIS SUBTALAR IMPLANT
K071456
Arthrex, Inc.
Orthopedic · 237d
Cleared Jan 17, 2008
GRYPHON BR AND HEALIX BR ANCHORS
K073412
Depuy Mitek, A Johnson & Johnson Company
Orthopedic · 44d
Cleared Aug 03, 2007
MODIFICATION TO: ARTHREX INTERFERENCE SCREW
K071176
Arthrex, Inc.
Orthopedic · 98d
Cleared May 02, 2007
MODIFICATION TO: BIOKNOTLESS BR ANCHOR / LUPINE BR ANCHOR
K070925
Depuy Mitek, A Johnson & Johnson Company
Orthopedic · 29d
Cleared Nov 29, 2006
ARTHREX INTERFERENCE SCREW
K062466
Arthrex, Inc.
Orthopedic · 97d
Cleared Jun 29, 2005
PUSHLOCK
K051219
Arthrex, Inc.
Orthopedic · 48d
Cleared Jul 29, 2004
SUTURE ARROW
K041128
Linvatec Corp.
Orthopedic · 90d