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
361–384 of 601
Cleared Nov 09, 2012
MICRO/MINI N-PK(H) BONE ANCHOR
K121356
Anulex Technologies, Inc.
Orthopedic · 189d
Cleared Oct 31, 2012
QUATRO LINK KNOTLESS ANCHOR WITH INSERTER, 2.9MM-PEEK ONLY
K122314
Cayenne Medical, Inc.
Orthopedic · 91d
Cleared Oct 11, 2012
APERFIX AM FEMORAL IMPLANT WITH INSERTER, 9X24 APERFIX AM FEMORAL IMPLANT WITH INSERTER, 10X24 APERFIX FEMORAL IMPLANT W
K122463
Cayenne Medical, Inc.
Orthopedic · 59d
Cleared Oct 02, 2012
6-8MM X 30 MM INTRAFIX PEEK TAPERED SCREW 7-9MM X 30MM INTRAFIX PEEK TAPERED SCREW 8-10MM X 30 MM INTRAFIX PEEK TAPERED
K122123
Depuy Mitek, Inc., A Johnson and Johnson Company
Orthopedic · 76d
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 Jun 07, 2012
APPIANFX SUTURE ANCHOR (6MM) (5MM) APPIANFX TISSUE ANCHOR
K120841
Kfx Medical
Orthopedic · 79d
Cleared Apr 20, 2012
PARCUS TWIST 4 5MM PEEK SUTURE ANCHOR, PARCUS TWIST 5.5MM PEEK SUTURE ANCHOR & PARCUS TRIPLE TWIST 5.5MM PEEK SUTURE ANC
K120942
Parcus Medical, LLC
Orthopedic · 22d
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 Mar 02, 2012
KNOTILUS ANCHOR SYSTEM
K113297
T.A.G. Medical Products Corporation, Ltd.
Orthopedic · 115d
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 17, 2012
CUFFINK
K112814
Cayenne Medical, Inc.
Orthopedic · 112d
Cleared Jan 17, 2012
PARCUS 35 KNOTLESS PEEK CF PUSH-IN SUTURE ANCHORS, PARCUS 45 KNOTLESS PEEK CF PUSH-IN SUTURE ANCHORS
K113730
Parcus Medical, LLC
Orthopedic · 29d
Cleared Jan 13, 2012
VARIOUS
K112417
Depuy Mitek, A Johnson & Johnson Company
Orthopedic · 143d
Cleared Jan 09, 2012
LABRALINK SUTURE ANCHOR WITH INSERTER, 2.9MM PER-LOADED WITH ONE (1) AND (2) #2 UHMWPE SUTURE
K112960
Cayenne Medical, Inc.
Orthopedic · 96d
Cleared Dec 15, 2011
CUFFLINK(TM) KNOTLESS ANCHOR WITH INSERTER, 4.5MM/5.5MM - PEEK ONLY, CUFFLINK SP(TM) KNOTLESS ANCHOR WITH INSERTER, 4.5
K112876
Cayenne Medical, Inc.
Orthopedic · 76d
Cleared Dec 15, 2011
ROG SUTURE ANCHOR
K113299
Rog Sports Medicine, Inc.
Orthopedic · 37d
Cleared Dec 08, 2011
MODIFIED ROG SUTURE ANCHOR
K112991
Rog Sports Medicine, Inc.
Orthopedic · 63d
Cleared Dec 01, 2011
LATERAL BUTTON
K112296
T.A.G. Medical Products Corporation, Ltd.
Orthopedic · 114d