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 2026-09-17

Integrity Retractable Implant Inserter (6000127)

Applicant Anika Therapeutics, Inc.

K number K261869

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MBI 2026-09-02

ArthroTAK Tendon Anchor Kit

Applicant ArthroTAK, LLC

K number K262809

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MBI 2026-09-02

Aevumed SUPERCYNCH™ Button System

Applicant Aevumed, Inc.

K number K253065

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MBI 2026-08-27

Iconix Knotless T

Applicant Riverpoint Medical

K number K262677

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MBI 2026-08-03

Grappler Suture Anchor System

Applicant Paragon 28, Inc.

K number K262047

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MBI 2026-07-30

AIR+ All-Inside Meniscal Repair Device, Curved Up;AIR+ All-Inside Meniscal Repair Device, Curved Down

Applicant Stryker Endoscopy

K number K262369

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MBI 2026-07-29

Suture Button Repair System

Applicant Skeletal Dynamics, Inc.

K number K261770

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MBI 2026-07-20

Thunderbolt System

Applicant Responsive Arthroscopy, Inc.

K number K261632

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MBI 2026-07-09

Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE suture (72205981); Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one blue knotless and one black MINITAPE suture (72205982)

Applicant Smith & Nephew, Inc.

K number K261968

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MBI 2026-06-26

Arthrex FiberButton

Applicant Arthrex, Inc.

K number K260018

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MBI 2026-05-27

Dione PEEK Screw System

Applicant ZheJiang Decans Medical Devices Co., Ltd.

K number K253130

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MBI 2026-05-13

Y-Knotless™ Flex Anchors

Applicant CONMED Corporation

K number K261363

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MBI 2026-05-06

Anchor with Fiber Wire and Disposable Inserter

Applicant Ortobio S.A.

K number K253027

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MBI 2026-05-01

ArthroTAK Tendon Anchor Kit

Applicant ArthroTAK, LLC

K number K252635

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MBI 2026-04-21

Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor Line

Applicant Tigon Medical

K number K260921

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MBI 2026-03-20

Arthrex FiberTak Suture Anchor

Applicant Arthrex, Inc.

K number K260561

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MBI 2026-03-17

Grappler Suture Anchor PCFD Tether System

Applicant Paragon 28, Inc.

K number K253886

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MBI 2026-03-16

SINEFIX

Applicant BAAT Medical Products B.V.

K number K254176

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MBI 2026-03-12

Trax EX Anchor

Applicant Trax Surgical, Inc.

K number K251750

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MBI 2026-03-11

Strut Suture; No-Tie Button

Applicant Riverpoint Medical, LLC

K number K253693

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MBI 2026-03-09

FiberTape Button

Applicant Arthrex, Inc.

K number K260405

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MBI 2026-03-06

TeKBrace Knotless Anchor

Applicant Theramicro

K number K253538

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MBI 2026-03-04

Aevumed FENIX Suture Anchor

Applicant Aevumed, Inc.

K number K254306

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MBI 2026-03-02

Arthrex Nano FiberTak Suture Anchor

Applicant Arthrex, Inc.

K number K254229

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MBI 2026-02-27

LigaMend

Applicant Riverpoint Medical, LLC

K number K253695

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MBI 2026-01-29

Y-Knotless™ Flex Anchors

Applicant Conmed Corporation

K number K253763

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MBI 2026-01-28

Aevumed PROTEKT Suture Anchor

Applicant Aevumed, Inc.

K number K260004

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MBI 2026-01-06

QuadLock™ Fixation System

Applicant Abanza Tecnomed S.L

K number K253618

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MBI 2025-12-30

Arthrex SwiveLock Suture Anchor, 3.5 x 10 mm

Applicant Arthrex, Inc.

K number K253895

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MBI 2025-12-04

Tigon Medical Knotless and Dual Javelin All-Suture Anchors

Applicant Tigon Medical

K number K252596

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MBI 2025-11-04

GMReis Suture Anchors

Applicant GM Dos Reis Industria e Comercio Ltda.

K number K252664

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MBI 2025-10-29

Arthrex SutureTak Suture Anchor

Applicant Arthrex, Inc.

K number K252314

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MBI 2025-10-21

Aevumed FASE Suture Anchor

Applicant Aevumed, Inc.

K number K253040

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MBI 2025-10-14

Mini Superhawk Suture Anchor System

Applicant Responsive Arthroscopy, LLC

K number K253010

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MBI 2025-09-05

All-Suture Dual Anchor System

Applicant Suturetech, Inc.

K number K250095

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MBI 2025-08-06

Aevumed PHANTOM Suture Anchors

Applicant Aevumed, Inc.

K number K242895

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MBI 2025-07-30

Iconix Speed Anchor; Iconix Speed HA+ Anchor

Applicant Riverpoint Medical

K number K252144

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MBI 2025-07-22

OTS 25-L (100-5)

Applicant Ots Medical , Ltd.

K number K251310

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MBI 2025-07-18

Arthrex FiberTak Suture Anchor

Applicant Arthrex, Inc.

K number K251809

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MBI 2025-07-10

Arthrex PushLock Suture Anchors

Applicant Arthrex, Inc.

K number K251145

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MBI 2025-07-01

SnugFit ASA Extension

Applicant Medacta International S.A.

K number K251933

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MBI 2025-06-25

BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid blue); BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid black); BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (white); BIORAPTOR CURVED 2.3 PK Suture Anchor w/ ONE 38 ULTRABRAID (#2) Suture (cobraid black); BIORAPTOR CURVED 2.3 PK Suture Anchor w/ ONE 38 ULTRABRAID (#2) Suture (cobraid blue)

Applicant Smith & Nephew, Inc.

K number K251627

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MBI 2025-06-18

CONMED Argo Knotless® Anchor

Applicant Conmed Corporation

K number K251530

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MBI 2025-06-02

PULLUP®; PULLUP® CLIP; BT LOOP®; PULLUP® TEX CLIP; RIGIDLOOP™ T; RIGIDLOOP™ Clip; RIGIDLOOP™ BTB; RIGIDLOOP™ Suture Loop

Applicant Science & Bio Materials (S.B.M.) Sas

K number K250844

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MBI 2025-05-12

Shoulder Soft Tissue Anchors

Applicant Signature Orthopaedics Pty, Ltd.

K number K242477

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MBI 2025-03-28

Arthrex FiberTak Suture Anchor

Applicant Arthrex, Inc.

K number K250596

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MBI 2025-03-20

RootMend MRR

Applicant Riverpoint Medical, LLC

K number K243988

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MBI 2025-03-11

Arthrex TightRope Soft Button, RT

Applicant Arthrex, Inc.

K number K250424

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MBI 2025-02-25

WasherCap™ Fixation System

Applicant Abanza Tecnomed S.L

K number K250238

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MBI 2025-02-19

SuperBall-RC™

Applicant Arcuro Medical , Ltd.

K number K244015

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MBI 2025-01-31

Crius PEEK Suture Anchor System (Thread-Fix Anchor); Crius PEEK Suture Anchor System (Thread-Fix Ultra Anchor); Crius PEEK Suture Anchor System (Helicoil Anchor); Crius PEEK Suture Anchor System (Pile Anchor)

Applicant ZheJiang Decans Medical Devices Co., Ltd.

K number K243665

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MBI 2025-01-30

Osprey Suture Anchor

Applicant Responsive Arthroscopy, Inc.

K number K243726

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MBI 2025-01-30

WasherCap™ Mini Fixation System (Model 45)

Applicant Abanza Tecnomed S.L

K number K243712

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MBI 2025-01-28

Argo Knotless GENESYS Anchor

Applicant Conmed Corporation

K number K244025

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MBI 2025-01-23

OTS 25-L (100-5)

Applicant Ots Medical , Ltd.

K number K241234

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MBI 2024-12-20

Tigon Medical All-Suture Anchors (ASA)

Applicant Tigon Medical

K number K242529

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MBI 2024-12-03

Fix2Lock (PEEK Self Punching)

Applicant Osteonic Co., Ltd.

K number K243470

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MBI 2024-11-26

OsseoFit Interfacing Anchor; OsseoFit Bone Tunnel Construct

Applicant Riverpoint Medical, LLC

K number K242494

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MBI 2024-11-19

Iconix Knotless Anchor

Applicant Riverpoint Medical

K number K243323

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MBI 2024-10-29

OC JuggerKnotless Soft Anchor; OC JuggerLoop Soft Anchor

Applicant Riverpoint Medical

K number K243203

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MBI 2024-09-12

Extremity All Suture System

Applicant Field Orthopaedics

K number K241695

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MBI 2024-08-29

VersaTap™ Suture Anchor (ADP050); VersaPEEK™ Suture Anchor (APP002); MicroTi™ Suture Anchor (ATP003-M); VersaLat™ Ti Suture Anchor (ADP021-TI); VersaLat™ Suture Anchor (ADP021-PK)

Applicant Ortho-Design (Pty), Ltd.

K number K242296

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MBI 2024-08-02

Fixone Meniscal Repair

Applicant Aju Pharm Co., Ltd.

K number K233601

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MBI 2024-07-25

Grappler Interference Screw System

Applicant Paragon 28, Inc.

K number K241864

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MBI 2024-07-19

Suture Button Repair System

Applicant Skeletal Dynamics, Inc.

K number K240835

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MBI 2024-07-03

Iconix® Anchor

Applicant Riverpoint Medical

K number K241577

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MBI 2024-06-20

Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one ULTRABRAID suture, blue; Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one ULTRABRAID suture, co-braid-blue; Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one MINITAPE suture, blue; Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one MINITAPE suture, co-braid-blue

Applicant Smith & Nephew, Inc.

K number K241435

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MBI 2024-05-29

Arthrex TightRope II

Applicant Arthrex, Inc.

K number K241235

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MBI 2024-05-03

Megaloop Button System

Applicant Suzhou Endophix Co., Ltd.

K number K232941

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MBI 2024-04-11

OC JuggerKnot Soft Anchor

Applicant Riverpoint Medical

K number K240719

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MBI 2024-03-26

Grappler Suture Anchor R3FLEX IOL System

Applicant Paragon 28, Inc.

K number K240594

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MBI 2024-03-07

ICONIX All-Suture Anchor; ICONIX TT All-Suture Anchor; ICONIX with Needles All-Suture Anchor

Applicant Stryker Endoscopy

K number K240407

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MBI 2024-02-23

Iconix Knotless Anchor

Applicant Riverpoint Medical

K number K240213

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MBI 2024-02-21

ProCinch, QuadCinch

Applicant Riverpoint Medical

K number K240194

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MBI 2024-01-25

AlphaVent Knotless SP PEEK Anchor

Applicant Stryker Endoscopy

K number K233893

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MBI 2024-01-17

Footprint Mini PK, 3.5mm Suture Anchor

Applicant Smith & Nephew

K number K233730

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MBI 2024-01-04

CEPTRE® Knotted UHMWPE Suture PEEK Anchor

Applicant Healthium Medtech Limited

K number K231033

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MBI 2023-12-28

SURESTITCH™ UHMWPE Suture PEEK Button Meniscus Repair Implant

Applicant Healthium Medtech Limited

K number K230891

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MBI 2023-12-26

Suture Wing

Applicant Osteonic Co., Ltd.

K number K233659

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MBI 2023-12-07

OTS 25 (100-1)

Applicant Ots Medical , Ltd.

K number K233429

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MBI 2023-11-30

IDEAL Ziploop

Applicant Riverpoint Medical

K number K233552

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MBI 2023-11-15

Arthrex Knee FiberTak® Button Suture Anchor

Applicant Arthrex, Inc.

K number K232973

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MBI 2023-11-14

Iconix Anchor

Applicant Riverpoint Medical

K number K233468

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MBI 2023-11-08

INFILOOP® Fixed Loop UHMWPE Suture Titanium Button

Applicant Healthium Medtech Limited

K number K232886

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MBI 2023-11-03

Arthrex FiberTak Suture Anchor

Applicant Arthrex, Inc.

K number K232742

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MBI 2023-11-02

Javelot Ti Suture Anchor, Javelot Ti-D Suture Anchor

Applicant Suzhou Endophix Co., Ltd.

K number K232725

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MBI 2023-10-24

Knotilus+ PEEK Knotless Anchor

Applicant Stryker Endoscopy

K number K232683

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MBI 2023-10-23

Shadow Knotless All-Suture Anchors

Applicant Responsive Arthroscopy, LLC

K number K233258

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MBI 2023-10-06

2.7 mm GRYPHON™ Flex Knotless PEEK Anchor; 2.7 mm GRYPHON™ Flex Knotless Biocomposite Anchor

Applicant Medos International SARL

K number K232492

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MBI 2023-10-06

JuggerKnot Soft Anchor OC

Applicant Riverpoint Medical, LLC

K number K232411

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MBI 2023-10-05

All-Suture Anchor

Applicant Riverpoint Medical, LLC

K number K231078

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MBI 2023-09-20

CITRELOCK® DUO

Applicant Acuitive Technologies, Inc.

K number K232592

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MBI 2023-09-11

Legends Orthopedics Suture Anchors (Legends Orthopedics 5.5 mm Suture Anchors, Legends Orthopedics 2.9 mm Suture Anchor, and Legends Orthopedics 5.5 mm Knotless Suture Anchor)

Applicant Jarmon Medical, LLC (Dba Legends Orthopedics)

K number K230517

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MBI 2023-09-08

Q-FIX ULTRA All-Suture Anchor

Applicant Smith & Nephew

K number K232457

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MBI 2023-09-01

Arthrex 2.4mm Knotless Hip SutureTak® Suture Anchor

Applicant Arthrex, Inc.

K number K232340

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MBI 2023-08-30

AlphaVent Suture Anchors

Applicant Stryker Endoscopy

K number K231093

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MBI 2023-08-25

Responsive Arthroscopy Stealth and Mini Stealth All-Suture Anchors

Applicant Responsive Arthroscopy, LLC

K number K230094

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MBI 2023-08-21

Grappler Suture Anchor System

Applicant Paragon 28, Inc.

K number K231867

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MBI 2023-08-09

Q-FIX With Needles (Q-FIX With Needles, #0 Suture & Q-FIX With Needles, Minitape)

Applicant Smith & Nephew, Inc.

K number K231376

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MBI 2023-08-08

Arthrex TightRope II

Applicant Arthrex, Inc.

K number K231857

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