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
145–168 of 221
Cleared Nov 19, 2004
DUET SUTURE ANCHOR, MODELS BXS4216, BXS4216H
K042966
Linvatec Biomaterials, Ltd.
Orthopedic · 22d
Cleared Oct 05, 2004
AXYA MEDICAL, INC. MODEL 5000 AXYALOOP BIO-ABSORBABLE BONE ANCHOR
K041698
Axya Medical, Inc.
Orthopedic · 105d
Cleared Jul 29, 2004
SUTURE ARROW
K041128
Linvatec Corp.
Orthopedic · 90d
Cleared Jun 14, 2004
STRYKER BIOZIP SUTURE ANCHOR SYSTEM
K041305
Stryker Endoscopy
Orthopedic · 28d
Cleared Jun 14, 2004
MODIFICATION TO STRYKER XCEL ANCHOR SYSTEM
K041307
Stryker Endoscopy
Orthopedic · 28d
Cleared Apr 30, 2004
PANALOK LOOP ANCHOR
K040827
Depuy Mitek, A Johnson & Johnson Company
Orthopedic · 31d
Cleared Aug 08, 2003
TWIN FIX AB 6.5 MM SUTURE ANCHOR, MODELS 720209, 7210210, 7210211, 7210212
K032197
Smith & Nephew, Inc.
Orthopedic · 21d
Cleared Jul 25, 2003
2.4 SMARTNAIL, MODELS 532416, 532425, 532435, 532445
K031981
Linvatec Biomaterials, Ltd.
Orthopedic · 29d
Cleared Jun 06, 2003
CUFFLOK ANCHOR
K031519
Mitek Worldwide
Orthopedic · 22d
Cleared Nov 02, 2001
SMITH & NEPHEW PHOENIX 5.0 ALLOGRAFT ANCHOR KIT
K011985
Smith & Nephew, Inc.
Orthopedic · 129d
Cleared Oct 29, 2001
MULTITAK SPLINTER 3.0 MM RESORBABLE ANCHOR
K012465
Bonutti Research, Inc.
Orthopedic · 89d
Cleared Oct 12, 2001
BIOCUFF,C, MODELS 236018, 236028, 236036
K013057
Bionx Implants, Inc.
Orthopedic · 30d
Cleared Sep 19, 2001
CONTOUR MENISCUS ARROW, MODELS 541110, 541113, AND 541116
K012334
Bionx Implants, Inc.
Orthopedic · 57d
Cleared Aug 01, 2001
ARTHREX BIO-POST AND WASHER
K011495
Arthrex, Inc.
Orthopedic · 78d
Cleared Jun 27, 2001
SMITH AND NEPHEW 5.00MM ABSORBABLE POLYMER ANCHOR
K011299
Smith & Nephew, Inc.
Orthopedic · 58d
Cleared Mar 19, 2001
SUPER REVO SUTURE ANCHOR
K003984
Linvatec Corp.
Orthopedic · 83d
Cleared Feb 15, 2001
MITEK 2GII MENISCAL REPAIR SYSTEM
K002406
Mitek Products
Orthopedic · 192d
Cleared Feb 09, 2001
SYNTHES MODIFIED BIORESORBABLE SUTURE ANCHOR SYSTEM
K003743
Synthes (Usa)
Orthopedic · 67d
Cleared Jan 12, 2001
CONTOUR LABRAL NAIL, MODEL 533520A
K003970
Bionx Implants, Inc.
Orthopedic · 21d
Cleared Jan 11, 2001
LACTOSORB SCREW ANCHOR
K003273
Biomet, Inc.
Orthopedic · 85d
Cleared Jan 08, 2001
BIO-ABSORBABLE CORKSCREW MODEL AR-1920B
K003227
Arthrex, Inc.
Orthopedic · 84d
Cleared Oct 27, 2000
MITEK CUFFTACK
K003076
Mitek Products
Orthopedic · 24d
Cleared Sep 19, 2000
ULTRASORB SUTURE ANCHOR
K002413
Li Medical Technologies, Inc.
Orthopedic · 43d
Cleared Aug 25, 2000
LACTOSORB MENISCAL SCREW
K002020
Biomet Manufacturing, Inc.
Orthopedic · 53d