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
529–552 of 601
Cleared Apr 23, 1997
IN-FAST BONE SCREW SYSTEM/IN-FAST BONE SCREW INSERTER/IN-FAST BONE SCREW
K970292
Influence, Inc.
Orthopedic · 89d
Cleared Apr 16, 1997
INNOVASIVE 8MM LIGAMENT FASTENER
K970316
Innovasive Devices, Inc.
Orthopedic · 82d
Cleared Mar 25, 1997
INNOVASIVE 2.8MM AND 3.5MM ROC LF SUTURE BONE FASTENER
K970089
Innovasive Devices, Inc.
Orthopedic · 74d
Cleared Feb 24, 1997
INNOVASIVE DEVICES ROTATOR CUFF FASTNER
K964945
Innovasive Devices, Inc.
Orthopedic · 76d
Cleared Feb 18, 1997
STABILIZER SOFT TISSUE ANCHOR MODEL NUMBER TA1005, TA1008, ANCHOR INSERTER/SUTURE ORGANIZER MODEL NUMBERS AI1005, AI1008
K965111
R. Thomas Grotz, M.D., Inc.
Orthopedic · 60d
Cleared Feb 12, 1997
ANSPACH SUTURE ANCHOR
K965069
The Anspach Effort, Inc.
Orthopedic · 61d
Cleared Feb 07, 1997
STABILIZER SOFT TISSUE ANCHOR, 8MM MODEL TA1008, ANCHOR INSERTER/SUTURE ORGANIZER, 8MM MODEL AI1008, STABILIZER DRILL, 8
K964927
R. Thomas Grotz, M.D., Inc.
Orthopedic · 60d
Cleared Feb 06, 1997
ANCHORLOK RL SOFT TISSUE ANCHOR SYSTEM
K964786
Wrightmedicaltechnologyinc
Orthopedic · 69d
Cleared Feb 03, 1997
MULTITAK SS SUTURE SYSTEM
K964532
Bonutti Research
Orthopedic · 83d
Cleared Jan 10, 1997
MULTITAK SS SUTURE SYSTEM
K964324
Bonutti Research
Orthopedic · 72d
Cleared Nov 25, 1996
ANSPACH SUTURE ANCHOR (MODIFIED)
K963686
The Anspach Effort, Inc.
Orthopedic · 74d
Cleared Nov 13, 1996
LM BONE ANCHOR
K963288
Li Medical Technologies, Inc.
Orthopedic · 84d
Cleared Nov 12, 1996
LM BONE ANCHOR (ORTHOPEDICS)
K963812
Li Medical Technologies, Inc.
Orthopedic · 64d
Cleared Nov 06, 1996
MITEK MICRO ANCHOR
K962511
Mitek Products
Orthopedic · 132d
Cleared Nov 04, 1996
INNOVASIVE 2.8MM ROC SUTURE BONE FASTENER AND 3.5MM ROC SUTURE BONE FASTENER
K963402
Innovasive Devices, Inc.
Orthopedic · 67d
Cleared Oct 03, 1996
MITEK THREADED ANCHOR (MODIFICATION)
K961094
Mitek Products
Orthopedic · 203d
Cleared Oct 02, 1996
QUESTUS POLYESTER SUTURE SOFT TISSUE ANCHOR SYSTEM
K963200
Wrightmedicaltechnologyinc
Orthopedic · 48d
Cleared Oct 02, 1996
ANCHORLOK II SOFT TISSUE ANCHOR SYSTEM
K963217
Wrightmedicaltechnologyinc
Orthopedic · 47d
Cleared Aug 27, 1996
STATAK SOFT TISSUE ATTACHMENT DEVICE
K962397
Zimmer, Inc.
Orthopedic · 67d
Cleared Jul 30, 1996
MLI SOFT TISSUE SCREW & WASHER SYSTEM
K962194
Medicinelodge, Inc.
Orthopedic · 53d
Cleared Apr 30, 1996
LM ANCHOR OR OTHER PROPRIETARY NAME
K960825
Li Medical Technologies, Inc.
Orthopedic · 61d
Cleared Apr 23, 1996
QUESTLOCK ACL FIXATOR
K954683
Wrightmedicaltechnologyinc
Orthopedic · 195d
Cleared Apr 18, 1996
LM BONE ANCHOR
K960439
Li Medical Technologies, Inc.
Orthopedic · 78d
Cleared Apr 18, 1996
FASTAK SUTURE ANCHOR
K960516
Arthrex, Inc.
Orthopedic · 73d