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., Smith & Nephew, Inc. and Arthrocare Corp..

599
Total
599
Cleared
100d
Avg days
1995
Since
599 devices
289–312 of 599
Cleared May 03, 2013
KNOTLESS FIBERTAK SUTURE ANCHOR
K130458
Arthrex, Inc.
Orthopedic · 70d
Cleared Mar 18, 2013
ALL-SUTURE ANCHOR TWIST DRILL FOR ALL-SUTURE ANCHORS INLINE DRILL GUIDE FOR ALL-SUTURE ANCHORS
K122059
Smith & Nephew, Inc.
Orthopedic · 248d
Cleared Feb 27, 2013
SPEEDLOCK KNOTLESS FIXATION DEVICE, 3MM DRILL, 3MM+ DRILL, PATHFINDER OBTURATOR & SHARP TIPPED OBTURATOR, LOW PROFILE DR
K130196
Arthrocare Corp.
Orthopedic · 30d
Cleared Feb 20, 2013
TWINFIX TI 3.5MM SUTURE ANCHOR WITH TWO ULTRABRAID SUTURE #2 WITH NEEDLES, SL
K123425
Smith & Nephew, Inc.
Orthopedic · 105d
Cleared Feb 14, 2013
SPEEDLOCK HIP KNOTLESS FIXATION IMPLANT
K123240
ArthroCare Corporation
Orthopedic · 121d
Cleared Jan 23, 2013
FOOTPRINT ULTRA PK4.5MM AND 5.5MM SUTURE ANCHOR, SL
K123579
Smith & Nephew, Inc.
Orthopedic · 65d
Cleared Dec 21, 2012
ARTHREX PEC REPAIR BUTTON, ARTHREX LARGE PEC BUTTON, ARTHREX BICEPS BUTTON, ARTHREX PROXIMAL BICEPS BUTTON
K123341
Arthrex, Inc.
Orthopedic · 51d
Cleared Sep 21, 2012
SPEEDLOCK HIP KNOTLESS FIXATION IMPLANT SPEEDLOCK HIP DRILL SPEEDLOCK HIP GUIDE CROWN TIP SPEEDLOCK HIP PATHFINDER
K120943
ArthroCare Corporation
Orthopedic · 176d
Cleared Jul 26, 2012
STRYKER ALL SUTURE ANCHORS
K120509
Stryker
Orthopedic · 156d
Cleared Jul 18, 2012
3.9MM REELX STT SUTURE ANCHOR SYSTEM
K120824
Stryker Corp.
Orthopedic · 121d
Cleared Jun 22, 2012
BIORAPTOR 2.9, BIORAPTOR 2.3 PK, OSTEORAPTOR, & BIORAPTOR KNOTLESS SUTURE AN
K121018
Smith & Nephew, Inc.
Orthopedic · 79d
Cleared Mar 27, 2012
MULTIFIX P KNOTLESS FIXATION DEVICE
K120096
ArthroCare Corporation
Orthopedic · 75d
Cleared Mar 06, 2012
FOOTPRINT ULTRA PK SUTURE ANCHOR
K113274
Smith & Nephew, Inc.
Orthopedic · 120d
Cleared Feb 17, 2012
ARTHREX KNOTLESS SUTURETAK ANCHOR
K120155
Arthrex, Inc.
Orthopedic · 30d
Cleared Jan 31, 2012
TWINFIX ULTRA TI, TWINFIX ULTRA PK, TWINFIX ULTRA HA SUTURE ANCHORS
K112526
Smith & Nephew, Inc.
Orthopedic · 153d
Cleared Jan 20, 2012
SMITH & NEPHEW HEALICOIL PK SUTURE ANCHOR
K113294
Smith & Nephew, Inc.
Orthopedic · 73d
Cleared Jan 13, 2012
VARIOUS
K112417
Depuy Mitek, A Johnson & Johnson Company
Orthopedic · 143d
Cleared Aug 19, 2011
ARTHREX SCAPHOLUNATE ANCHOR
K111661
Arthrex, Inc.
Orthopedic · 66d
Cleared Aug 09, 2011
SPEEDLOCK KNOTLESS FIXATION DEVICE
K111044
ArthroCare Corporation
Orthopedic · 116d
Cleared Jul 22, 2011
GIL ANCHOR / GIL QUICK ANCHOR PLUS, HEALIX TI DUAL THREADED SUTURE ANCHOR, ROTATOR CUFF ANCHOR / ROTATOR CUFF QUICK AN..
K111631
Depuy Mitek, A Johnson & Johnson Company
Orthopedic · 39d
Cleared Jul 20, 2011
SPEEDFIX SUTURE IMPLANT, 3.0MM DRILL, PATHFINDER OBTURATOR, SHARP TIPPED OBTRURATOR, LOW PROFILE DRILL GUIDE MODEL OM-75
K111399
Arthrocare Corp.
Orthopedic · 62d
Cleared Jul 12, 2011
TITAN TI SUTURE ANCHOR SYSTEM
K111397
Arthrocare Corp.
Orthopedic · 54d
Cleared Jun 24, 2011
SMITH & NEPHEW NEXT GENERATION FULLY THREADED PEEK SUTURE ANCHOR (NGFTSA PK)
K110545
Smith & Nephew, Inc.
Orthopedic · 119d
Cleared Jun 02, 2011
TORNIER INSITE FT SUTURE ANCHOR
K110773
Tornier, Inc.
Orthopedic · 73d