Atlas FDA

MBI

600 FDA 510(k) clearances · Product code

81 daysmedian time to decision
210 days90th percentile
600clearances measured

FDA profile

Official device name
Fastener, Fixation, Nondegradable, Soft Tissue
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3040
Medical specialty
Orthopedic
Flags
Implant
Adverse events (MAUDE)
2021: 1,890 · 2022: 1,591 · 2023: 2,503 · 2024: 3,778 · 2025: 3,875 · 2026: 2,623
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Grappler Suture Anchor System (K262047)Paragon 28, Inc.2026-08-03
AIR+ All-Inside Meniscal Repair Device, Curved Up;AIR+ All-Inside Meniscal Repair Device, Curved Down (K262369)Stryker Endoscopy2026-07-30
Suture Button Repair System (K261770)Skeletal Dynamics, Inc.2026-07-29
Thunderbolt System (K261632)Responsive Arthroscopy, Inc.2026-07-20
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) (K261968)Smith & Nephew, Inc.2026-07-09
Arthrex FiberButton (K260018)Arthrex, Inc.2026-06-26
Dione PEEK Screw System (K253130)ZheJiang Decans Medical Devices Co., Ltd.2026-05-27
Y-Knotless™ Flex Anchors (K261363)CONMED Corporation2026-05-13
Anchor with Fiber Wire and Disposable Inserter (K253027)Ortobio S.A.2026-05-06
ArthroTAK Tendon Anchor Kit (K252635)ArthroTAK, LLC2026-05-01
Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor Line (K260921)Tigon Medical2026-04-21
Arthrex FiberTak Suture Anchor (K260561)Arthrex, Inc.2026-03-20
Grappler Suture Anchor PCFD Tether System (K253886)Paragon 28, Inc.2026-03-17
SINEFIX (K254176)BAAT Medical Products B.V.2026-03-16
Trax EX Anchor (K251750)Trax Surgical, Inc.2026-03-12
Strut Suture; No-Tie Button (K253693)Riverpoint Medical, LLC2026-03-11
FiberTape Button (K260405)Arthrex, Inc.2026-03-09
TeKBrace Knotless Anchor (K253538)Theramicro2026-03-06
Aevumed FENIX Suture Anchor (K254306)Aevumed, Inc.2026-03-04
Arthrex Nano FiberTak Suture Anchor (K254229)Arthrex, Inc.2026-03-02
LigaMend (K253695)Riverpoint Medical, LLC2026-02-27
Y-Knotless™ Flex Anchors (K253763)Conmed Corporation2026-01-29
Aevumed PROTEKT Suture Anchor (K260004)Aevumed, Inc.2026-01-28
QuadLock™ Fixation System (K253618)Abanza Tecnomed S.L2026-01-06
Arthrex SwiveLock Suture Anchor, 3.5 x 10 mm (K253895)Arthrex, Inc.2025-12-30
Tigon Medical Knotless and Dual Javelin All-Suture Anchors (K252596)Tigon Medical2025-12-04
GMReis Suture Anchors (K252664)GM Dos Reis Industria e Comercio Ltda.2025-11-04
Arthrex SutureTak Suture Anchor (K252314)Arthrex, Inc.2025-10-29
Aevumed FASE Suture Anchor (K253040)Aevumed, Inc.2025-10-21
Mini Superhawk Suture Anchor System (K253010)Responsive Arthroscopy, LLC2025-10-14
All-Suture Dual Anchor System (K250095)Suturetech, Inc.2025-09-05
Aevumed PHANTOM Suture Anchors (K242895)Aevumed, Inc.2025-08-06
Iconix Speed Anchor; Iconix Speed HA+ Anchor (K252144)Riverpoint Medical2025-07-30
OTS 25-L (100-5) (K251310)Ots Medical , Ltd.2025-07-22
Arthrex FiberTak Suture Anchor (K251809)Arthrex, Inc.2025-07-18
Arthrex PushLock Suture Anchors (K251145)Arthrex, Inc.2025-07-10
SnugFit ASA Extension (K251933)Medacta International S.A.2025-07-01
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) (K251627)Smith & Nephew, Inc.2025-06-25
CONMED Argo Knotless® Anchor (K251530)Conmed Corporation2025-06-18
PULLUP®; PULLUP® CLIP; BT LOOP®; PULLUP® TEX CLIP; RIGIDLOOP™ T; RIGIDLOOP™ Clip; RIGIDLOOP™ BTB; RIGIDLOOP™ Suture Loop (K250844)Science & Bio Materials (S.B.M.) Sas2025-06-02
Shoulder Soft Tissue Anchors (K242477)Signature Orthopaedics Pty, Ltd.2025-05-12
Arthrex FiberTak Suture Anchor (K250596)Arthrex, Inc.2025-03-28
RootMend MRR (K243988)Riverpoint Medical, LLC2025-03-20
Arthrex TightRope Soft Button, RT (K250424)Arthrex, Inc.2025-03-11
WasherCap™ Fixation System (K250238)Abanza Tecnomed S.L2025-02-25
SuperBall-RC™ (K244015)Arcuro Medical , Ltd.2025-02-19
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) (K243665)ZheJiang Decans Medical Devices Co., Ltd.2025-01-31
Osprey Suture Anchor (K243726)Responsive Arthroscopy, Inc.2025-01-30
WasherCap™ Mini Fixation System (Model 45) (K243712)Abanza Tecnomed S.L2025-01-30
Argo Knotless GENESYS Anchor (K244025)Conmed Corporation2025-01-28
OTS 25-L (100-5) (K241234)Ots Medical , Ltd.2025-01-23
Tigon Medical All-Suture Anchors (ASA) (K242529)Tigon Medical2024-12-20
Fix2Lock (PEEK Self Punching) (K243470)Osteonic Co., Ltd.2024-12-03
OsseoFit Interfacing Anchor; OsseoFit Bone Tunnel Construct (K242494)Riverpoint Medical, LLC2024-11-26
Iconix Knotless Anchor (K243323)Riverpoint Medical2024-11-19
OC JuggerKnotless Soft Anchor; OC JuggerLoop Soft Anchor (K243203)Riverpoint Medical2024-10-29
Extremity All Suture System (K241695)Field Orthopaedics2024-09-12
VersaTap™ Suture Anchor (ADP050); VersaPEEK™ Suture Anchor (APP002); MicroTi™ Suture Anchor (ATP003-M); VersaLat™ Ti Suture Anchor (ADP021-TI); VersaLat™ Suture Anchor (ADP021-PK) (K242296)Ortho-Design (Pty), Ltd.2024-08-29
Fixone Meniscal Repair (K233601)Aju Pharm Co., Ltd.2024-08-02
Grappler Interference Screw System (K241864)Paragon 28, Inc.2024-07-25
Suture Button Repair System (K240835)Skeletal Dynamics, Inc.2024-07-19
Iconix® Anchor (K241577)Riverpoint Medical2024-07-03
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 (K241435)Smith & Nephew, Inc.2024-06-20
Arthrex TightRope II (K241235)Arthrex, Inc.2024-05-29
Megaloop Button System (K232941)Suzhou Endophix Co., Ltd.2024-05-03
OC JuggerKnot Soft Anchor (K240719)Riverpoint Medical2024-04-11
Grappler Suture Anchor R3FLEX IOL System (K240594)Paragon 28, Inc.2024-03-26
ICONIX All-Suture Anchor; ICONIX TT All-Suture Anchor; ICONIX with Needles All-Suture Anchor (K240407)Stryker Endoscopy2024-03-07
Iconix Knotless Anchor (K240213)Riverpoint Medical2024-02-23
ProCinch, QuadCinch (K240194)Riverpoint Medical2024-02-21
AlphaVent Knotless SP PEEK Anchor (K233893)Stryker Endoscopy2024-01-25
Footprint Mini PK, 3.5mm Suture Anchor (K233730)Smith & Nephew2024-01-17
CEPTRE® Knotted UHMWPE Suture PEEK Anchor (K231033)Healthium Medtech Limited2024-01-04
SURESTITCH™ UHMWPE Suture PEEK Button Meniscus Repair Implant (K230891)Healthium Medtech Limited2023-12-28
Suture Wing (K233659)Osteonic Co., Ltd.2023-12-26
OTS 25 (100-1) (K233429)Ots Medical , Ltd.2023-12-07
IDEAL Ziploop (K233552)Riverpoint Medical2023-11-30
Arthrex Knee FiberTak® Button Suture Anchor (K232973)Arthrex, Inc.2023-11-15
Iconix Anchor (K233468)Riverpoint Medical2023-11-14
INFILOOP® Fixed Loop UHMWPE Suture Titanium Button (K232886)Healthium Medtech Limited2023-11-08
Arthrex FiberTak Suture Anchor (K232742)Arthrex, Inc.2023-11-03
Javelot Ti Suture Anchor, Javelot Ti-D Suture Anchor (K232725)Suzhou Endophix Co., Ltd.2023-11-02
Knotilus+ PEEK Knotless Anchor (K232683)Stryker Endoscopy2023-10-24
Shadow Knotless All-Suture Anchors (K233258)Responsive Arthroscopy, LLC2023-10-23
2.7 mm GRYPHON™ Flex Knotless PEEK Anchor; 2.7 mm GRYPHON™ Flex Knotless Biocomposite Anchor (K232492)Medos International SARL2023-10-06
JuggerKnot Soft Anchor OC (K232411)Riverpoint Medical, LLC2023-10-06
All-Suture Anchor (K231078)Riverpoint Medical, LLC2023-10-05
CITRELOCK® DUO (K232592)Acuitive Technologies, Inc.2023-09-20
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) (K230517)Jarmon Medical, LLC (Dba Legends Orthopedics)2023-09-11
Q-FIX ULTRA All-Suture Anchor (K232457)Smith & Nephew2023-09-08
Arthrex 2.4mm Knotless Hip SutureTak® Suture Anchor (K232340)Arthrex, Inc.2023-09-01
AlphaVent Suture Anchors (K231093)Stryker Endoscopy2023-08-30
Responsive Arthroscopy Stealth and Mini Stealth All-Suture Anchors (K230094)Responsive Arthroscopy, LLC2023-08-25
Grappler Suture Anchor System (K231867)Paragon 28, Inc.2023-08-21
Q-FIX With Needles (Q-FIX With Needles, #0 Suture & Q-FIX With Needles, Minitape) (K231376)Smith & Nephew, Inc.2023-08-09
Arthrex TightRope II (K231857)Arthrex, Inc.2023-08-08
HEALICOIL PK Suture Anchor with Needles, ULTRATAPE (Blue); HEALICOIL PK Suture Anchor with Needles, ULTRATAPE (Blue Cobraid) (K232005)Smith & Nephew, Inc.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 (K231404)Healthium Medtech Limited2023-08-04
Suture Anchors - HTA Headless Titanium Anchor and Zip Anchors (K223114)Gm Dos Reis Industria E Comerico Ltda.2023-08-02
Knotless Suture Anchor (K231278)Riverpoint Medical, LLC2023-08-01
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Every clearance here is in the API, with alerts when new ones post.