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
409–432 of 601
Cleared Oct 29, 2010
SPEEDFIX SUTURE SYSTEM
K101437
Arthrocare Corp.
Orthopedic · 158d
Cleared Oct 21, 2010
ARTHOCARE SPARTAN PEEK SUTURE IMPLANT SYSTEM
K102262
Arthrocare Corp.
Orthopedic · 72d
Cleared Oct 20, 2010
INTRAFIX TIBIAL SHEATH
K102443
Depuy Mitek, A Johnson & Johnson Company
Orthopedic · 55d
Cleared Jun 21, 2010
OPUS SPEEDSCREW SYSTEM
K101448
Arthrocare Corp.
Orthopedic · 28d
Cleared Jun 11, 2010
G-FORCE PEEK SUTURE ANCHOR SYSTEM
K100630
Wrightmedicaltechnologyinc
Orthopedic · 98d
Cleared May 18, 2010
TITAN TI SUTURE ANCHOR SYSTEM, MODELS 22-9055, 22-9055N, 22-9065, 22-9065N, 22-9022, 22-9005,, 22-9006
K101184
Arthrocare Corp.
Orthopedic · 20d
Cleared Apr 05, 2010
SMITH & NEPHEW FOOTPRINT RCX PK SUTURE ANCHOR
K093935
Smith & Nephew, Inc.
Orthopedic · 104d
Cleared Mar 26, 2010
G-FORCE TI SUTURE ANCHOR SYSTEM
K100579
Wrightmedicaltechnologyinc
Orthopedic · 24d
Cleared Mar 18, 2010
ARTHREX TIBIAL GRAFTBOLT
K093912
Arthrex, Inc.
Orthopedic · 86d
Cleared Feb 04, 2010
OMNISPAN MENISCAL REPAIR SYSTEM/0 DEGREE, MODEL 228140, RAPIDLOC A2 MENISCAL REPAIR SYSTEM/12 DEGREE, MODEL 228141
K092836
Depuy Mitek, A Johnson & Johnson Company
Orthopedic · 142d
Cleared Dec 23, 2009
CONMED LINVATEC INTERCEPT IMPLANT
K092998
Linvatec Corp.
Orthopedic · 86d
Cleared Dec 17, 2009
SMITH & NEPHEW KNOTLESS INSTABILITY ANCHOR
K093428
Smith & Nephew Endoscopy, Inc.
Orthopedic · 44d
Cleared Dec 15, 2009
SMITH & NEPHEW TWINFIX ULTRA PK SUTURE ANCHOR
K093228
Smith & Nephew, Inc.
Orthopedic · 61d
Cleared Sep 30, 2009
PARCUS V-LOX PEEK CF SUTURE ANCHOR, MODELS: 10253, 10254, 10263, 10264
K091094
Parcus Medical, LLC
Orthopedic · 167d
Cleared Sep 21, 2009
TORNIER, PITON FIXATION IMPLANT SYSTEM
K091870
Tornier
Orthopedic · 90d
Cleared Jun 30, 2009
PARCUS GRAFT FIXATION SYSTEM
K090923
Parcus Medical, LLC
Orthopedic · 90d
Cleared Jun 23, 2009
CONMED LINVATEC SOFT TISSUE TO BONE SYSTEM
K091549
Linvatec Corp.
Orthopedic · 27d
Cleared Jun 17, 2009
MAGNUM MP FIXATION DEVICE
K091503
Arthrocare Corp.
Orthopedic · 27d
Cleared Jun 03, 2009
OPUS SPEEDLOCK KNOTLESS FIXATION DEVICE
K090615
Arthrocare Corp.
Orthopedic · 86d
Cleared Mar 13, 2009
MAGNUM M FIXATION DEVICE
K090380
Arthrocare Corp.
Orthopedic · 24d
Cleared Mar 06, 2009
PARCUS V-LOX TITANIUM SUTURE ANCHOR,MODELS: 10251, 10252, 10257, 10258
K090075
Parcus Medical, LLC
Orthopedic · 53d
Cleared Jan 30, 2009
SMITH & NEPHEW PEEK INTERFERENCE SCREW
K083226
Smith & Nephew Endoscopy, Inc.
Orthopedic · 88d
Cleared Jan 30, 2009
SMITH & NEPHEW BIOSURE PK INTERFERENCE SCREW
K083635
Smith & Nephew Endoscopy, Inc.
Orthopedic · 53d
Cleared Jan 22, 2009
EXTREMITY MEDICAL SUTURE ANCHOR
K083151
Extremity Medical, LLC
Orthopedic · 90d