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
337–360 of 601
Cleared Aug 01, 2013
TOGGLELOC XTENDER
K130033
Biomet Manufacturing Corp
Orthopedic · 209d
Cleared Aug 01, 2013
RIGIDLOOP FIXATION DEVICE (15MM, 60MM, XL, 20MM, 25MM, 30MM, 35MM, 40MM, 45MM, 50MM, 55MM
K130814
Depuy Mitek, A Johnson & Johnson Company
Orthopedic · 129d
Cleared Jul 29, 2013
MULTIFIX S KNOTLESS FIXATION DEVICE
K131182
Arthocare Corporation
Orthopedic · 94d
Cleared Jul 02, 2013
Y-KNOT FLEX ALL-SUTURE ANCHOR, W/ TWO #2 (5 METRIC) HI-FI SUTURES, 1.8MM
K131035
Linvatec Corporation D/B/A Conmed Linvatec
Orthopedic · 81d
Cleared Jun 27, 2013
HEALIX ADVANCE KNOTLESS PEEK ANCHOR (6.5MM)
K131683
Depuy Mitek, Inc., A Johnson and Johnson Company
Orthopedic · 17d
Cleared Jun 20, 2013
ORTHOPEDIATRICS ACL RECONSTRUCTIVE SYSTEM
K130217
OrthoPediatrics Corp.
Orthopedic · 142d
Cleared May 21, 2013
HEALIX ADVANCE KNOTLESS PEEK ANCHOR (4.75MM)(5.5MM)
K130539
Depuy Mitek, A Johnson & Johnson Company
Orthopedic · 81d
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 Mar 18, 2013
JUGGERKNOTLESS SOFT ANCHORS, JUGGERKNOTLESS M SOFT ANCHORS, JUGGERKNOTLESS SOFT ANCHORS WITH NEEDLES, JUGGERKNOTLESS SOF
K123485
Biomet Sports Medicine
Orthopedic · 125d
Cleared Mar 14, 2013
NANOTACK SUTURE ANCHOR 1.4MM WITH FLEX INSERTER
K130351
Pivot Medical, Inc.
Orthopedic · 30d
Cleared Mar 07, 2013
ECLIPSE SOFT TISSUE FASTENER
K123350
MedShape, Inc.
Orthopedic · 127d
Cleared Mar 05, 2013
COLS® FIXATION SYSTEM
K120740
Fournitures Hospitalieres Industrie
Orthopedic · 358d
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 21, 2013
CINCHLOCK KNOTLESS SUTURE ANCHOR
K123651
Pivot Medical
Orthopedic · 86d
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 Feb 05, 2013
PARCUS DRAW TIGHT 1.8MM SINGLE-LOADED SUTURE ANCHOR
K122805
Parcus Medical, LLC
Orthopedic · 145d
Cleared Jan 23, 2013
FOOTPRINT ULTRA PK4.5MM AND 5.5MM SUTURE ANCHOR, SL
K123579
Smith & Nephew, Inc.
Orthopedic · 65d
Cleared Jan 09, 2013
Q-FIX SUTURE ANCHOR, 1.8MM Q-FIX ACCESS TOOLS (DRILL GUIDE W/OBTURATOR, DRILL BIT) 1.8MM
K122336
Eleven Blade Solutions, Inc.
Orthopedic · 160d
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 Dec 19, 2012
CINCHER-2.6 SUTURE ANCHOR MODEL FG-001
K122954
Foundry Newcoxi, Inc.
Orthopedic · 85d
Cleared Dec 11, 2012
NCS FISH-FIT MD SYSTEM FISH-FIT MD COMPASS MD
K120356
Ncs Lab Srl
Orthopedic · 309d
Cleared Nov 09, 2012
MICRO/MINI N-PK(F) BONE ANCHOR
K121354
Anulex Technologies, Inc.
Orthopedic · 189d