MBI · Class II · 21 CFR 888.3040

FDA Product Code MBI: Fastener, Fixation, Nondegradable, Soft Tissue

FDA product code MBI covers nondegradable soft tissue fixation fasteners.

These orthopedic implants are used to anchor soft tissue — such as tendons and ligaments — to bone during reconstructive procedures. They are designed to remain permanently in the body without degrading over time.

MBI devices are Class II medical devices, regulated under 21 CFR 888.3040 and reviewed by the FDA Orthopedic panel.

Leading manufacturers include Arthrex, Inc., Innovasive Devices, Inc. and Parcus Medical, LLC.

601
Total
601
Cleared
100d
Avg days
1995
Since
601 devices
505–528 of 601
Cleared Apr 16, 1998
HARPOON SUTURE ANCHORS
K973775
Biomet, Inc.
Orthopedic · 195d
Cleared Mar 16, 1998
ACUMED SUTURE ANCHOR
K980103
Acu Med, Inc.
Orthopedic · 63d
Cleared Feb 18, 1998
INNOVASIVE LINX BT 10MM LIGAMENT FASTENER
K974049
Innovasive Devices, Inc.
Orthopedic · 117d
Cleared Feb 13, 1998
MITEK KNOTLESS ANCHOR
K974345
Mitek Products
Orthopedic · 86d
Cleared Feb 06, 1998
PEBA ANCHOR/SUTURE COMBINATION
K972326
Orthopaedic Biosystems, Ltd.
Orthopedic · 228d
Cleared Jan 30, 1998
MITEK ABSORBABLE POLYDIOXANONE (PDS) H FIX
K970119
Mitek Products
Orthopedic · 381d
Cleared Jan 30, 1998
CRANIOFACIAL ANCHORS
K974136
Biomet, Inc.
Orthopedic · 88d
Cleared Dec 01, 1997
ACL CLIP-IN
K973323
Innovasive Devices, Inc.
Orthopedic · 88d
Cleared Nov 10, 1997
MITEK NON ABSORBABLE POLYPROPYLENE H FIX
K973009
Mitek Products
Orthopedic · 89d
Cleared Oct 28, 1997
CSCO FOREHEAD FIXATION SYSTEM
K963502
Howmedica Corp.
Orthopedic · 420d
Cleared Oct 09, 1997
STRAIGHT-IN BONE SCREW FIXATION SYSTEM
K972622
Influence, Inc.
Orthopedic · 87d
Cleared Oct 09, 1997
MULTITAK SS SUTURE SYSTEM
K973015
Bonutti Research
Orthopedic · 57d
Cleared Sep 26, 1997
INNOVASIVE 2.3MM ROC XS SUTURE BONE FASTENER
K972438
Innovasive Devices, Inc.
Orthopedic · 88d
Cleared Aug 26, 1997
INNOVASIVE 2.3MM ROC EZ SUTURE BONE FASTENER
K972356
Innovasive Devices, Inc.
Orthopedic · 62d
Cleared Aug 07, 1997
INNOVASIVE 2.8MM AND 3.5MM ROC EZ SUTURE BONE FASTENER
K971922
Innovasive Devices, Inc.
Orthopedic · 76d
Cleared Jul 30, 1997
FASTAK SUTURE ANCHOR (11.7MM)/(7.5MM)
K971723
Arthrex, Inc.
Orthopedic · 82d
Cleared Jul 30, 1997
VAGINAL SUTURING KIT FOR LAPAROTOMY BLADDER NECK SUSPENSION
K971791
Louisville Laboratories, Inc.
Orthopedic · 76d
Cleared Jul 30, 1997
VAGINAL SUTURING KIT FOR BLADDER NECK SUSPENSION
K971802
Louisville Laboratories, Inc.
Orthopedic · 76d
Cleared Jul 09, 1997
AMS MAINSTAY UROLOGIC BONE ANCHOR
K971332
American Medical Systems, Inc.
Orthopedic · 90d
Cleared Jun 27, 1997
ANCHORLOK AND ANCHORLOK RL SOFT TISSUE ANCHOR SYSTEM
K971282
Wrightmedicaltechnologyinc
Orthopedic · 81d
Cleared Jun 25, 1997
BONE ANCHOR SYSTEM FOR SOFT TISSUE SUPPORT
K971139
Boston Scientific Corp
Orthopedic · 89d
Cleared Jun 25, 1997
MULTITAK SS SUTURE SYSTEM
K971144
Bonutti Research
Orthopedic · 89d
Cleared Jun 20, 1997
PRELOADED SOFT TISSUE ANCHOR
K963932
Linvatec Corp.
Orthopedic · 262d
Cleared Apr 30, 1997
INNOVASIVE ROCLET BONE TUNNEL AUGMENTATION DEVICE
K970423
Innovasive Devices, Inc.
Orthopedic · 85d