Atlas FDA

HTN

93 FDA 510(k) clearances · Product code

90 daysmedian time to decision
210 days90th percentile
93clearances measured

FDA profile

Official device name
Washer, Bolt Nut
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3030
Medical specialty
Orthopedic
Flags
Implant
Adverse events (MAUDE)
2021: 149 · 2022: 85 · 2023: 108 · 2024: 269 · 2025: 194 · 2026: 130
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
LARS ACJ (K253115)Movmedix S.A.S.2026-06-10
SportLinc Syndesmosis Device (K252081)Lincotek Medical2026-03-27
Syndesmosis TightRope PRO (K253727)Arthrex, Inc.2025-12-22
Synchfix EVT (K251643)Wright Medical Technology, Inc. (Stryker Corporation)2025-10-29
RipCord (K251134)TriMed, Inc.2025-07-11
Acu-Sinch Knotless Mini (K243624)Acumed, LLC2025-01-23
Bolo Button System (K242091)Fusion Orthopedics2024-12-23
TACTIX Vector Syndesmosis System (K243408)Vilex, LLC2024-11-27
EXPERT - Flexible Joint Fixation System (K242311)GM Dos Reis Industria e Comercio Ltda.2024-11-01
TACTIX Vector Syndesmosis System (K240035)Vilex, LLC2024-08-01
TENSOR® Suture Button System (K240947)Globus Medical, Inc.2024-06-03
OIC FLEX-FIX™ System (K233531)Orthopaedic Implant Company2024-02-02
CC-Clip® Implant System (K232780)Cc-Instruments, Inc.2023-12-18
Arthrex FiberTape and TigerTape Cerclage Sutures (K232755)Arthrex, Inc.2023-10-06
Arthrex FiberTape and TigerTape Cerclage Sutures (K221485)Arthrex, Inc.2022-08-22
Arthrex Knotless AC Repair Devices (K220947)Arthrex, Inc.2022-06-06
TriMed Ripcord Device (K220650)TriMed, Inc.2022-06-01
Hercules Syndesmosis Implant System (K220260)In2bones USA, LLC2022-03-31
Acumed Ankle Syndesmosis Repair System (K212990)Acumed, LLC2022-01-07
Arthrex Knotless Mini TightRopes (K213644)Arthrex, Inc.2021-12-17
Medline UNITE REFLEX Dynamic Discs (K211612)Medline Industries, Inc.2021-12-10
EXPERT - Joint Fixation System (K200332)GM Dos Reis Industria e Comercio Ltda.2020-10-29
Arthrex Syndesmosis TightRope XP Buttress Plate Implant System (K201522)Arthrex, Inc.2020-09-03
Akros Scruture Anchor LisFranc Repair Kit (K200361)Akros Medical2020-04-06
LARS AC Band Device (K190143)Corin USA2019-11-04
MicroLink All-Suture Button Fixation System (Radiopaque) (K190582)Conmed Corporation2019-06-28
MicroLink All-Suture Button Fixation System (Radiolucent) (K190516)Conmed Corporation2019-06-28
CyclaPlex Correction System (K183094)Cycla Orthopedics, Ltd.2019-04-26
Double ENDOBUTTON Fixation Device (K183232)Smith and Nephew, Inc.2019-03-12
Infinity-Lock Button System (K180243)Xiros, Ltd.2018-04-03
PUMA System (K171703)Panther Orthopedics, Inc.2018-03-01
Akros FibuLink™ Syndesmosis Repair Kit (K173550)Akros Medical2017-12-14
SyndesMetrics Syndesmosis Repair System (K172620)Mortise Medical, LLC2017-11-08
GRAVITY™ Syndesmosis LP (K170249)Wrightmedicaltechnologyinc2017-06-30
INVISIKNOT Ankle Syndesmosis Repair Kit (K162996)Smith & Nephew, Inc.2017-06-08
KISSloc Suture System (K170440)Arthrosurface, Inc.2017-05-03
Akros Fibulink Syndesmosis Repair Kit (K162805)Akros Medical2017-01-10
M-Fix Acromioclavicular Device (K153211)Coracoid Solutions, Inc.2016-02-02
Tensyn Plug (K150359)Dallen Medical, Inc.2015-05-07
Tensyn Plug (K143092)Dallen Medical, Inc.2015-02-11
FASTFORWARD (K141420)MedShape, Inc.2014-12-18
TENSYN BAND, TENSYN FRACTURE PLATES (K141264)Dallen Medical, Inc.2014-08-21
JUGGERLOC BONE TO BONE IMPLANTS/ BONE INSTRUMENTS/ BONE IMPLANT AND INSTRUMENT KITS (K141219)Biomet Manufacturing Corp2014-07-18
ARTHROSURFACE KISSLOC KNOTLESS SUTURE SYSTEM (K133835)Arthrosurface, Inc.2014-07-03
CMC MINI TIGHTROPE (K140328)Arthrex, Inc.2014-03-10
TENSYN BAND (K133858)Dallen Medical, Inc.2014-02-28
MINI TIGHTROPE (K133275)Arthrex, Inc.2014-01-30
ORTHOHELIX SYNDESMOSIS FIXATION DEVICES (K132733)Orthohelix Surgical Designs, Inc.2014-01-03
TENSYN BAND (K131850)Dallen Medical, Inc.2013-11-15
BIOPRO - INFINITY PLATE ANCHOR SYSTEM (K132510)Biopro, Inc.2013-10-24
FRAG-LOC SYSTEM (K130986)Acumed, LLC2013-07-23
ARTHREX FRACTURE SYSTEM (K112437)Arthrex, Inc.2011-12-21
ACU-SINCH REPAIR SYSTEM AND ACUMED SUTURE ANCHOR (K112111)Acumed, LLC2011-11-14
CMC CABLE FIX (K111032)Instratek, Inc.2011-08-31
SURGICRAFT LOCKDOWN ACROMIOCLAVICULAR (AC) DEVICE (K091207)Surgicraft , Ltd.2011-02-15
CABLE READY CABLE GRIP SYSTEM CABLE BUTTON (K091799)Zimmer, Inc.2009-09-11
MICHELANGELO BUNION SYSTEM - MABS, MODEL: MA6000 (K091763)Instratek, Inc.2009-08-14
MINI TIGHTROPE (K090107)Arthrex, Inc.2009-08-06
HAV-LOK BUNION CORRECTION SYSTEM (K082384)Instratek, Inc.2008-12-08
ULTRASLIDE ACROMIOCLAVICULAR AND SYNDESMOTIC REPAIR DEVICE (K082095)Smith & Nephew Endoscopy, Inc.2008-10-21
MINI TIGHTROPE FT REPAIR KIT (K071978)Arthrex, Inc.2007-08-15
MINI TIGHTROPE REPAIR KIT, MODEL AR-8911DS (K061925)Arthrex, Inc.2006-10-31
TIGHTROPE ACROMIOCLAVICULAR (AC) DEVICE, TITANIUM, STAINLESS STEEL , MODELS AR-2257, AR-TBD (K052776)Arthrex, Inc.2005-12-13
BI-CORTICAL BIO-POST AND WASHER, MODEL AR-1367B (K043145)Arthrex, Inc.2005-02-18
RESOFIX BIOABSORBABLE EXPANSION BOLT (K043411)Resofix, Inc.2005-02-17
TIGHTROPE SYNDESMOSIS REPAIR KIT, TITANIUM, MODEL AR-8920DS; STAINLESS STEEL. MODEL AR-8921DS (K043248)Arthrex, Inc.2005-02-16
BONE-LOK HP WASHER (K040250)Triage Medical, Inc.2004-03-23
ODI 7.0MM CANNULATED SCREW SYSTEM (K030619)Orthopedic Designs, Inc.2003-04-01
BI-CORTICAL BIO POST AND WASHER, MODEL AR-1367B (K023119)Arthrex, Inc.2002-12-18
SYNTHES METALLIC SPIKED WASHERS (K013806)Synthes (Usa)2002-02-08
SPIKED WASHER (K011583)Synthes (Usa)2002-01-30
CANNULATED SCREW SYSTEM (K003496)Pioneer Surgical Technology2001-02-08
HEX BUTTON (K992617)Pioneer Surgical Technology1999-10-27
SOFT TISSUE SUTURE WASHER (K991135)Depuy, Inc.1999-04-29
DEPUY ORTHOTECH SPIKED WASHER (K983906)DePuy Orthopaedics, Inc.1998-12-18
SD TRANS-OSSEOUS FASTENER MODELS TOB 6 BOLT 32/50, TOB 6 BOLT 50/80, TOB 6 BOLT 80/140, TOB 6 WASHER MODELS 12MM 16MM 1M (K982354)Special Devices, Inc.1998-11-23
DEPUY ACE COMPOSITE LOCKING NUT (K983265)Depuy Ace Medical Co.1998-10-26
SYNTHES SCHUHLI IMPLANT SYSTEM (K980944)Synthes (Usa)1998-04-27
ACUMED SUTURE WASHER (K965028)Acu Med, Inc.1997-03-17
CANCELLOUS SCREW WASHER (K963420)Orthopaedic Biosystems, Ltd.1996-11-15
WASHER, BOLT, NUT, ORTHOPEDIC (K954682)Linvatec Corp.1996-02-09
SUTURE WASHER (K954148)Acu Med, Inc.1996-01-17
BONE SCREW WASHER (K943782)Acu Med, Inc.1994-12-20
SYNTHES (USA) TITANIUM LOCKED SPIKED WASHER (K924455)Synthes (Usa)1993-05-12
SPIKED WASHER (K914472)Synthes (Usa)1991-11-07
T-BOLT AND NUT (K911306)Danek Medical, Inc.1991-09-10
WYMAN SUTURE WASHER (K910186)Acu Med, Inc.1991-07-25
SOFT TISSUE SUTURE WASHER/3 HOLE WASHER (K910229)Depuy, Inc.1991-07-24
ACE ORTHOPAEDIC WASHERS (K895107)Buckman Co., Inc.1989-09-11
ACROMED WASHERS (K881699)Buckman Co., Inc.1988-04-27
ACE BONE SCREW NUT (K874669)Buckman Co., Inc.1987-12-11
KAPP SPINAL BUTTON (K843368)Kapp Surgical Instrument, Inc.1984-09-12
TECHMEDICA-HEWSON SHOULDER CLEAT (K834411)Techmedica, Inc.1984-01-17

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Every clearance here is in the API, with alerts when new ones post.