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
457–480 of 601
Cleared Jun 25, 2004
OPUS MAGNUM ANCHOR WITH INSERTER
K041440
Opus Medical, Inc.
Orthopedic · 24d
Cleared Jun 14, 2004
STRYKER WEDGE SUTURE ANCHOR SYSTEM
K041310
Stryker Endoscopy
Orthopedic · 28d
Cleared Jun 07, 2004
FEMORAL HOOK
K041261
Arthrotek, Inc.
Orthopedic · 27d
Cleared Feb 13, 2004
TITANIUM TOGGLE BUTTON(S)
K033838
Biomet Manufacturing, Inc.
Orthopedic · 65d
Cleared Nov 25, 2002
ENDOTACK
K022853
KARL STORZ Endoscopy-America, Inc.
Orthopedic · 90d
Cleared Nov 22, 2002
ULTRAFIX KNOTLESS MINIMITE SUTURE ANCHOR
K022827
Linvatec Corp.
Orthopedic · 88d
Cleared Oct 04, 2002
AXYA MODEL 3000 AXYALOOP TITANIUM BONE ANCHOR SYSTEM
K022207
Axya Medical, Inc.
Orthopedic · 88d
Cleared Dec 19, 2001
PRE-LOADED ULTRAFIX RC
K013553
Linvatec Corp.
Orthopedic · 55d
Cleared Nov 16, 2001
LACTOSORB CRANIOFACIAL ANCHOR-PUSH SCREW
K013557
Walter Lorenz Surgical, Inc.
Orthopedic · 23d
Cleared Oct 22, 2001
METAL SCREW ANCHOR
K012503
Biomet Manufacturing, Inc.
Orthopedic · 80d
Cleared Aug 31, 2001
MODEL 2000 AXYALOOP SELF-TAPPING BONE ANCHOR, MODEL 2000
K011912
Axya Medical, Inc.
Orthopedic · 73d
Cleared Jun 12, 2001
TENODESIS SCREW, 5.5 MM, MODEL AR-1350-55
K011007
Arthrex, Inc.
Orthopedic · 69d
Cleared Jun 06, 2001
BONUS-ORTHOPEDIC BONE SCREW FIXATION SYSTEM
K011390
Disc-O-Tech Medical Technologies, Ltd.
Orthopedic · 30d
Cleared May 14, 2001
ARTHREX TWISTLOC SUTURE ANCHOR, MODEL AR-1924
K010457
Arthrex, Inc.
Orthopedic · 87d
Cleared Mar 21, 2001
AXYA MEDICAL, INC. MODEL 1000 AXYALOOP BONE ANCHOR
K003971
Axya Medical, Inc.
Orthopedic · 89d
Cleared Feb 09, 2001
STERILE BUTTON PLATE
K010121
Synthes (Usa)
Orthopedic · 24d
Cleared Nov 15, 2000
LITWIN CRUICATE ANCHOR
K002600
Instrument Makar, Inc.
Orthopedic · 86d
Cleared Mar 15, 2000
SYNTHES BUTTON PLATE
K994364
Synthes (Usa)
Orthopedic · 79d
Cleared Mar 01, 2000
STAPLETAC2 BONE ANCHOR SYSTEM
K000279
American Medical Systems, Inc.
Orthopedic · 30d
Cleared Jan 13, 2000
ACUMED SUTURE ANCHOR
K993657
Acu Med, Inc.
Orthopedic · 77d
Cleared Dec 02, 1999
TALON ANCHOR SNAP-PAK
K993261
Mitek Products
Orthopedic · 64d
Cleared Oct 14, 1999
RC MULTISUTURE BONE ANCHOR, MODEL 4453/4454
K992458
Innovasive Devices, Inc.
Orthopedic · 83d
Cleared Oct 08, 1999
RC TACK
K992377
Innovasive Devices, Inc.
Orthopedic · 85d
Cleared Mar 05, 1999
MULTITAK SS BUTTONS
K990156
Bonutti Research
Orthopedic · 45d