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
265–288 of 599
Cleared Jul 09, 2015
GraftMax Button, ALB with Cradle, GraftMax Button, BTB with Cradle
K151037
Conmed Corporation
Orthopedic · 80d
Cleared Jul 02, 2015
Arthrex Corkscrew and SwiveLock Suture Anchors
K143745
Arthrex, Inc.
Orthopedic · 183d
Cleared Jun 29, 2015
Stryker ICONIX with Needles
K151201
Stryker
Orthopedic · 55d
Cleared Jun 19, 2015
Arthrex FiberTak Anchors
K151230
Arthrex, Inc.
Orthopedic · 42d
Cleared May 15, 2015
JuggerStitch Meniscal Repair Device
K150424
Biomet Manufacturing Corp
Orthopedic · 85d
Cleared Oct 24, 2014
4.5mm Healix Ti Anchor, with 2 or 3 strands of #2 Permacord suture, 5.5mm Healix Ti Anchor, with 2 or 3 strands of #2 Permacord suture, 6.5mm Healix Ti Anchor, with 2 or 3 strands of #2 Permacord suture,
K142574
Depuy Mitek, A Johnson & Johnson Company
Orthopedic · 42d
Cleared Aug 13, 2014
ARTHREX FIBERTAK SUTURE ANCHOR
K140476
Arthrex, Inc.
Orthopedic · 168d
Cleared Jul 30, 2014
G-FORCE GEN 2 SUTURE ANCHOR SYSTEM
K141011
Wrightmedicaltechnologyinc
Orthopedic · 103d
Cleared Jul 21, 2014
BIOSURE HEALICOIL PK INTERFERENCE SCREW
K140879
Smith & Nephew, Inc.
Orthopedic · 105d
Cleared May 20, 2014
ACUMED SUTURE ANCHOR SYSTEM
K140925
Acumed, LLC
Orthopedic · 39d
Cleared May 14, 2014
MULTIFIX S KNOTLESS FIXATION SYSTEM
K140604
ArthroCare Corporation
Orthopedic · 65d
Cleared Apr 04, 2014
TORNIER INSITE(TM) FT PEEK KNOTLESS SUTURE ANCHOR
K133777
Tornier, Inc.
Orthopedic · 113d
Cleared Apr 01, 2014
N8TIVE ACL ANATOMIC RECONSTRUCTION SYSTEM, N8TIVE ACL FEMORAL IMPLANT, N8TIVE ACL TIBIAL IMPLANT, VARIOUS CLASS I ANCILL
K133606
ArthroCare Corporation
Orthopedic · 127d
Cleared Mar 10, 2014
ACUMED SUTURE ANCHOR SYSTEM
K133469
Acumed, LLC
Orthopedic · 118d
Cleared Feb 28, 2014
ICONIX ALL SUTURE ANCHORS
K133671
Stryker Corp.
Orthopedic · 91d
Cleared Jan 16, 2014
Q-FIX SUTURE ANCHOR, 1.8MM
K133727
ArthroCare Corporation
Orthopedic · 41d
Cleared Jan 03, 2014
Y-KNOT RC ALL-SUTURE ANCHOR, 2.8MM - DOUBLE LOADED AND TRIPLE LOADED W/ #2 HIFI SUTURES
K133224
Conmed Corporation
Orthopedic · 74d
Cleared Sep 19, 2013
Q-FIX SUTURE ANCHOR,1.8MM AND 2.8MM / DRILL, DRILL GUIDE AND OBTURATOR,1.8MM AND 2.8MM /BONE PUNCH,2.8MM AND KNOT PUSHER
K132513
ArthroCare Corporation
Orthopedic · 38d
Cleared Sep 19, 2013
TORNIER INSITE FT SUTURE ANCHOR WITH NEEDLES
K132632
Tornier, Inc.
Orthopedic · 28d
Cleared Sep 17, 2013
5.5MM MULTIFIX S KNOTLESS FIXATION DEVICE, 6.5MM MULTIFIX S KNOTLESS FIXATION DEVICE, INSERTION GUIDE WITH OBTURATOR, TA
K132590
ArthroCare Corporation
Orthopedic · 29d
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 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