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 Aug 08, 2003
TWIN FIX AB 6.5 MM SUTURE ANCHOR, MODELS 720209, 7210210, 7210211, 7210212
K032197
Smith & Nephew, Inc.
Orthopedic · 21d
Cleared Nov 02, 2001
SMITH & NEPHEW PHOENIX 5.0 ALLOGRAFT ANCHOR KIT
K011985
Smith & Nephew, Inc.
Orthopedic · 129d
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
Cleared Jul 28, 2000
BIOCUFF, MODELS 225718, 225728, 225736, 235718, 235728, 235736
K001378
Bionx Implants, Inc.
Orthopedic · 88d
Cleared Jul 28, 2000
SYNTHES BIORESORBABLE SUTURE ANCHOR
K994161
Synthes (Usa)
Orthopedic · 232d
Cleared May 01, 2000
BIO-FASTAK SUTURE ANCHOR, MODEL AR-1324B
K000506
Arthrex, Inc.
Orthopedic · 76d
Cleared Jan 28, 2000
ARTHREX PLA TISSUETAK, MODEL # AR-1940 BU
K990340
Arthrex, Inc.
Orthopedic · 359d
Cleared Jan 13, 2000
BIO-ABSORBABLE CORKSCREW, MODEL AR-1920B
K990987
Arthrex, Inc.
Orthopedic · 295d
Cleared Jan 10, 2000
TITAN RC TACK
K994269
Innovasive Devices, Inc.
Orthopedic · 21d
Cleared Dec 17, 1999
MULTITAK SS
K993115
Bonutti Research, Inc.
Orthopedic · 88d
Cleared Dec 10, 1999
SMART NAIL MODELS 521516, 521520,521525, 531516, 531520. 531525
K993074
Bionx Implants, Ltd.
Orthopedic · 87d
Cleared Dec 10, 1999
ENDOPEARL WITH THREADER
K993339
Linvatec Corp.
Orthopedic · 66d