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 Medacta International S.A..

594
Total
594
Cleared
101d
Avg days
1995
Since
594 devices
241–264 of 594
Cleared Sep 08, 2017
CuffLink Implant System
K171725
Conmed Corporation
Orthopedic · 88d
Cleared Aug 24, 2017
Stryker Self-Punching ICONIX
K171465
Stryker
Orthopedic · 98d
Cleared May 16, 2017
Arthrex Knotless SutureTak Anchor
K171020
Arthrex, Inc.
Orthopedic · 41d
Cleared Mar 31, 2017
ICONIX TT All Suture Anchor
K170098
Stryker
Orthopedic · 79d
Cleared Feb 23, 2017
GRAVITYTM PEEK-OPTIMA Suture Anchor
K170265
Wrightmedicaltechnologyinc
Orthopedic · 27d
Cleared Jan 25, 2017
CrossFT Knotless Suture Anchor with Disposable Driver
K163258
Conmed Corporation
Orthopedic · 65d
Cleared May 10, 2016
FiberTak DR
K160319
Arthrex, Inc.
Orthopedic · 95d
Cleared Feb 23, 2016
Arthrex Short Suture Anchors
K151092
Arthrex, Inc.
Orthopedic · 306d
Cleared Dec 02, 2015
PEBA Anchor/Suture Combination, 2.0mm Mini-Tac Anchor, Model 10-1629-01, Modification to Twinfix Ti Quick-T, Twinfix FT PK, Twinfix Ultra Ti, Twinfix Ultra PK, Twinfix Ultra HA Suture Anchors, FOOTPRINT Ultra OK Suture Anchors, BIORAPTOR 2.9 Suture Anchor, BIORAPTOR 2.3 PK Suture Anchor, OSTEORAPTOR Suture Anchor, BIORAPTOR Knotless Suture Anchor, HEALICOIL PK Suture Anchor (formerly Next Generation Fully Threaded Suture Anchor), Bioraptor Curved 2.3 PK Suture Anchors
K152566
Smith & Nephew, Inc.
Orthopedic · 84d
Cleared Aug 20, 2015
Arthrex DX SwiveLock SL with Forket Eyelet 3.5 x 8.5mm, Arthrex DX SwiveLock Suture Anchor, 3.5 x 13.5mm
K150648
Arthrex, Inc.
Orthopedic · 161d
Cleared Jul 02, 2015
Arthrex Corkscrew and SwiveLock Suture Anchors
K143745
Arthrex, Inc.
Orthopedic · 183d
Cleared Jun 19, 2015
Arthrex FiberTak Anchors
K151230
Arthrex, Inc.
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 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 20, 2013
TWINFIX TI 3.5MM SUTURE ANCHOR WITH TWO ULTRABRAID SUTURE #2 WITH NEEDLES, SL
K123425
Smith & Nephew, Inc.
Orthopedic · 105d
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 Jun 22, 2012
BIORAPTOR 2.9, BIORAPTOR 2.3 PK, OSTEORAPTOR, & BIORAPTOR KNOTLESS SUTURE AN
K121018
Smith & Nephew, Inc.
Orthopedic · 79d
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