Fastener, Fixation, Nondegradable, Soft Tissue
FDA product code MBI · 558 cleared devices
Class 2
Orthopedic
- Regulation
- 21 CFR 888.3040
- Review panel
- OR
- Implant
- Yes
- Life sustaining
- No
- Third party review
- No
- GMP exempt
- No
- Clearance span
- 1995-02-01 – 2026-09-17
MBI
2023-08-04
MBI
2023-08-04
T-Button® A Adjustable Loop UHMWPE Suture PEEK Button, Close Button, T-Button® S Adjustable Loop UHMWPE Suture PEEK Button, Open Button
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MBI
2023-08-02
Suture Anchors - HTA Headless Titanium Anchor and Zip Anchors
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MBI
2023-08-01
Knotless Suture Anchor
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MBI
2023-06-07
Fix2Lock(PEEK Self Punching)
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MBI
2023-06-07
Javelot PK-S suture anchor, Javelot PK-S suture anchor (Knotless), Javelot PK-P suture anchor, Javelot PK-P suture anchor (Knotless), Javelot PK-L suture anchor (Knotless)
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MBI
2023-06-01
FiberTak® Suture Anchor
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MBI
2023-05-23
Syntheface PEEK Interference Screw, Syntheface PEEK Screw Sheath
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MBI
2023-05-22
Integrity™ Bone Staple Fixation System
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MBI
2023-05-18
Arthrex FiberTak Suture Anchor
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MBI
2023-05-17
JuggerKnot Soft Anchor
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MBI
2023-05-03
PEEK RCI Screw; Bio-Composite Screw; SignaLoc Screw
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MBI
2023-05-03
Apollo Knotless Suture Anchor
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MBI
2023-04-17
SnugFit All-Suture Anchor extension
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MBI
2023-04-01
FiberTak Suture Anchor
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MBI
2023-03-23
Fixone All Suture Anchor
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MBI
2023-03-22
Stativ® Knotted UHMWPE Suture Anchor
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MBI
2023-03-22
Tigon Medical Gryphon Anchor Line
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MBI
2023-03-17
Aevumed RAPID Suture Anchors
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MBI
2023-03-10
Arthrex Knotless FiberTak Suture Anchor
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MBI
2023-03-08
SINEFIX
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MBI
2023-03-03
Grappler Suture Anchor R3FLEX IOL System
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MBI
2023-02-24
MectaLock TI Triple Loaded Suture Anchor
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MBI
2023-02-23
OrthoButton AL
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MBI
2023-02-17
ULTRABUTTON QUAD Adjustable Fixation Device; ULTRABUTTON BB Adjustable Fixation Device; ULTRABUTTON TIB SMALL Adjustable Fixation Device; ULTRABUTTON TIB MEDIUM Adjustable Fixation Device; ULTRABUTTON TIB LARGE Adjustable Fixation Device
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MBI
2023-02-04
Simparo Anchor Line Fixation System
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MBI
2023-02-02
SutureLoc™ Implant
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MBI
2023-01-26
Flexible Suturing System with Anchors (FSSA)
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MBI
2023-01-17
FairFix QT Adjustable Button
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MBI
2022-12-22
Arthrex FiberTak Suture Anchor
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MBI
2022-12-16
AUXILOCK PEEK OPTIMA Screw-In Suture Anchor, AUXILOCK ROTADOR PEEK OPTIMA Screw-In Anchor
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MBI
2022-11-28
Aevumed PHANTOM™-LP Suture Anchors
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MBI
2022-11-18
Auxilock GFS Mini, GFS II Large, and GFS Ultimate
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MBI
2022-10-13
Responsive Arthroscopy Mustang and Mustang Knotless Suture Anchors
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MBI
2022-09-22
WasherCap Fixation System
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MBI
2022-09-14
Grappler Suture Anchor System
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MBI
2022-09-07
FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch Implant, Straight with two Polyester Implants and 2-0 FiberWire
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MBI
2022-08-22
Auxilock Draw Tight Suture-Based Anchor
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MBI
2022-08-16
FairFix Adjustable Button System
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MBI
2022-08-11
Arthrex Knotless FiberTak Biceps Suture Anchor
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MBI
2022-07-29
S-Core Implant System
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MBI
2022-07-29
Auxilock Titanium Screw-In Suture Anchor
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MBI
2022-07-26
Parcus Synd-EZ SS
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MBI
2022-07-11
Mitek TIGHT-N Anchor
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MBI
2022-06-08
FairFix AM Adjustable Button FairFix PSP Adjustable Button
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MBI
2022-05-19
X-Twist PEEK Suture Anchor
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MBI
2022-05-13
Argo Knotless SP Anchor
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MBI
2022-04-15
FootHold System
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MBI
2021-12-06
VersaTap, VersaLat, DueLock, VersaTi, MiniTi
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MBI
2021-10-06
ActiFlip
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MBI
2021-08-30
Paratrooper Plantar Plate Repair System
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MBI
2021-08-04
Alpha Vent PEEK Suture Anchor
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MBI
2021-08-04
Tigon Medical Button System
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MBI
2021-07-07
Grappler Suture Anchor System
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MBI
2021-06-07
Suture Wing
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MBI
2021-06-04
Fix2Lock (PEEK Self Punching)
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MBI
2021-04-27
Responsive Arthroscopy Thunderbolt System
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MBI
2021-03-26
FairFix Adjustable Button System
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MBI
2021-03-24
Betta Link Knotless Implant System
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MBI
2021-03-11
Stryker ProCinch Adjustable Loop Device
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MBI
2021-02-22
Parcus Titanium Interference Screws
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MBI
2021-02-12
JuggerKnot Soft Anchor
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MBI
2021-02-11
TenoTac Soft Tissue Fixation System
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MBI
2021-02-01
HEALIX Ti Dual Threaded Suture Anchor with DYNATAPE Suture
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MBI
2021-01-19
SnugFit All-Suture Anchor
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MBI
2021-01-08
Button Loop
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MBI
2020-12-15
Fixone All Suture Anchor
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MBI
2020-11-27
Arthrex FiberTak Suture Anchor
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MBI
2020-11-25
Sterile bone screw (PEEK ACL screw)
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MBI
2020-11-25
TopLock Anchor System
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MBI
2020-11-17
Knotless TensionTight Button Implant System
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MBI
2020-11-13
Stryker Omega PEEK Knotless Anchor System
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MBI
2020-11-13
VersaLoop Anchor System
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MBI
2020-11-10
Multi-Drive Interference Screw System
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MBI
2020-11-10
WasherLoc and No-Profile Screw and Washer Systems, Biomet Cannulated Screw System, Biomet Headless Compression and Twist-Off Screws
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MBI
2020-11-04
Arthrex TightRope II
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MBI
2020-10-28
Parcus GFS II and GFS Mini, GFS Naked, GFS Ultimate, GFS BTB, ATLAS, Synd-EZ Ti, Actiflip Naked, Actiflip Cinch, Actiflip Whip, and GFS Ultimate Hip
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MBI
2020-10-16
PULLUP BTB Adjustable Fixation System for Ligament Reconstruction, PULLUP CLIP Adjustable Fixation System for Ligament Reconstruction, PULLUP TEX CLIP Adjustable Fixation System for Ligament Reconstruction, BT LOOP Adjustable Fixation System for Ligament Reconstruction
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MBI
2020-10-07
Flower Suture Anchor Set
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MBI
2020-09-18
OrthoButton FL
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MBI
2020-09-09
Responsive Arthroscopy Suture Anchor System
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MBI
2020-09-02
ATL Anchors
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MBI
2020-08-20
Hercules Suture Anchor System
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MBI
2020-08-07
6.5 mm Healix Advance SP Peek Anchor, 6.5 mm Healix Advance SP Biocomposite Anchor
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MBI
2020-07-23
Parcus V-lox Titanium Suture Anchors, Parcus Miti Suture Anchors
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MBI
2020-06-04
HEALIX ADVANCE Anchor with DYNATAPE Suture
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MBI
2020-03-26
Bonecam Suture Anchor
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MBI
2020-03-12
Arthrex FiberTak Suture Anchor
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MBI
2020-03-11
Apollo Suture Anchor System
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MBI
2020-03-05
ALLthread PEEK Suture Anchor
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MBI
2020-03-04
Coronet Soft Tissue Fixation System
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MBI
2020-02-14
Dunamis PunchTac Suture Anchors
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MBI
2020-02-10
MectaFix CL Fixation Button with Continuous Loop
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MBI
2020-02-06
MectaLock All-Suture Anchors
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MBI
2020-01-29
MectaTap TI Suture Anchor
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MBI
2020-01-24
Paratrooper Plantar Plate Repair System
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MBI
2020-01-23
Parcus Knotless PEEK and PEEK CF Push-In Suture Anchor
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MBI
2020-01-22
Y-Knot OneStep Anchor
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MBI
2020-01-16
ALLthread Titanium Suture Anchor
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MBI
2020-01-16
AcTiFlip Naked, AcTiFlip Cinch, AcTiFlip WHIP, GFS Ultimate Hip
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