Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Washer, Bolt Nut

FDA product code HTN · 83 cleared devices

Class 2 Orthopedic

Regulation: 21 CFR 888.3030
Review panel: OR
Implant: Yes
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1984-01-17 – 2026-06-10

HTN 2026-06-10

LARS ACJ

Applicant Movmedix S.A.S.

K number K253115

View details →

HTN 2026-03-27

SportLinc Syndesmosis Device

Applicant Lincotek Medical

K number K252081

View details →

HTN 2025-12-22

Syndesmosis TightRope PRO

Applicant Arthrex, Inc.

K number K253727

View details →

HTN 2025-10-29

Synchfix EVT

Applicant Wright Medical Technology, Inc. (Stryker Corporation)

K number K251643

View details →

HTN 2025-07-11

RipCord

Applicant TriMed, Inc.

K number K251134

View details →

HTN 2025-01-23

Acu-Sinch Knotless Mini

Applicant Acumed, LLC

K number K243624

View details →

HTN 2024-12-23

Bolo Button System

Applicant Fusion Orthopedics

K number K242091

View details →

HTN 2024-11-27

TACTIX Vector Syndesmosis System

Applicant Vilex, LLC

K number K243408

View details →

HTN 2024-11-01

EXPERT - Flexible Joint Fixation System

Applicant GM Dos Reis Industria e Comercio Ltda.

K number K242311

View details →

HTN 2024-08-01

TACTIX Vector Syndesmosis System

Applicant Vilex, LLC

K number K240035

View details →

HTN 2024-06-03

TENSOR® Suture Button System

Applicant Globus Medical, Inc.

K number K240947

View details →

HTN 2024-02-02

OIC FLEX-FIX™ System

Applicant Orthopaedic Implant Company

K number K233531

View details →

HTN 2023-12-18

CC-Clip® Implant System

Applicant Cc-Instruments, Inc.

K number K232780

View details →

HTN 2023-10-06

Arthrex FiberTape and TigerTape Cerclage Sutures

Applicant Arthrex, Inc.

K number K232755

View details →

HTN 2022-08-22

Arthrex FiberTape and TigerTape Cerclage Sutures

Applicant Arthrex, Inc.

K number K221485

View details →

HTN 2022-06-06

Arthrex Knotless AC Repair Devices

Applicant Arthrex, Inc.

K number K220947

View details →

HTN 2022-06-01

TriMed Ripcord Device

Applicant TriMed, Inc.

K number K220650

View details →

HTN 2022-03-31

Hercules Syndesmosis Implant System

Applicant In2bones USA, LLC

K number K220260

View details →

HTN 2022-01-07

Acumed Ankle Syndesmosis Repair System

Applicant Acumed, LLC

K number K212990

View details →

HTN 2021-12-17

Arthrex Knotless Mini TightRopes

Applicant Arthrex, Inc.

K number K213644

View details →

HTN 2021-12-10

Medline UNITE REFLEX Dynamic Discs

Applicant Medline Industries, Inc.

K number K211612

View details →

HTN 2020-10-29

EXPERT - Joint Fixation System

Applicant GM Dos Reis Industria e Comercio Ltda.

K number K200332

View details →

HTN 2020-09-03

Arthrex Syndesmosis TightRope XP Buttress Plate Implant System

Applicant Arthrex, Inc.

K number K201522

View details →

HTN 2020-04-06

Akros Scruture Anchor LisFranc Repair Kit

Applicant Akros Medical

K number K200361

View details →

HTN 2019-11-04

LARS AC Band Device

Applicant Corin USA

K number K190143

View details →

HTN 2019-06-28

MicroLink All-Suture Button Fixation System (Radiopaque)

Applicant Conmed Corporation

K number K190582

View details →

HTN 2019-06-28

MicroLink All-Suture Button Fixation System (Radiolucent)

Applicant Conmed Corporation

K number K190516

View details →

HTN 2019-04-26

CyclaPlex Correction System

Applicant Cycla Orthopedics, Ltd.

K number K183094

View details →

HTN 2019-03-12

Double ENDOBUTTON Fixation Device

Applicant Smith and Nephew, Inc.

K number K183232

View details →

HTN 2018-04-03

Infinity-Lock Button System

Applicant Xiros, Ltd.

K number K180243

View details →

HTN 2018-03-01

PUMA System

Applicant Panther Orthopedics, Inc.

K number K171703

View details →

HTN 2017-12-14

Akros FibuLink™ Syndesmosis Repair Kit

Applicant Akros Medical

K number K173550

View details →

HTN 2017-11-08

SyndesMetrics Syndesmosis Repair System

Applicant Mortise Medical, LLC

K number K172620

View details →

HTN 2017-06-30

GRAVITY™ Syndesmosis LP

Applicant Wrightmedicaltechnologyinc

K number K170249

View details →

HTN 2017-06-08

INVISIKNOT Ankle Syndesmosis Repair Kit

Applicant Smith & Nephew, Inc.

K number K162996

View details →

HTN 2017-05-03

KISSloc Suture System

Applicant Arthrosurface, Inc.

K number K170440

View details →

HTN 2017-01-10

Akros Fibulink Syndesmosis Repair Kit

Applicant Akros Medical

K number K162805

View details →

HTN 2016-02-02

M-Fix Acromioclavicular Device

Applicant Coracoid Solutions, Inc.

K number K153211

View details →

HTN 2013-11-15

TENSYN BAND

Applicant Dallen Medical, Inc.

K number K131850

View details →

HTN 2013-10-24

BIOPRO - INFINITY PLATE ANCHOR SYSTEM

Applicant Biopro, Inc.

K number K132510

View details →

HTN 2013-07-23

FRAG-LOC SYSTEM

Applicant Acumed, LLC

K number K130986

View details →

HTN 2011-12-21

ARTHREX FRACTURE SYSTEM

Applicant Arthrex, Inc.

K number K112437

View details →

HTN 2011-11-14

ACU-SINCH REPAIR SYSTEM AND ACUMED SUTURE ANCHOR

Applicant Acumed, LLC

K number K112111

View details →

HTN 2011-08-31

CMC CABLE FIX

Applicant Instratek, Inc.

K number K111032

View details →

HTN 2011-02-15

SURGICRAFT LOCKDOWN ACROMIOCLAVICULAR (AC) DEVICE

Applicant Surgicraft , Ltd.

K number K091207

View details →

HTN 2009-09-11

CABLE READY CABLE GRIP SYSTEM CABLE BUTTON

Applicant Zimmer, Inc.

K number K091799

View details →

HTN 2009-08-14

MICHELANGELO BUNION SYSTEM - MABS, MODEL: MA6000

Applicant Instratek, Inc.

K number K091763

View details →

HTN 2009-08-06

MINI TIGHTROPE

Applicant Arthrex, Inc.

K number K090107

View details →

HTN 2008-12-08

HAV-LOK BUNION CORRECTION SYSTEM

Applicant Instratek, Inc.

K number K082384

View details →

HTN 2008-10-21

ULTRASLIDE ACROMIOCLAVICULAR AND SYNDESMOTIC REPAIR DEVICE

Applicant Smith & Nephew Endoscopy, Inc.

K number K082095

View details →

HTN 2007-08-15

MINI TIGHTROPE FT REPAIR KIT

Applicant Arthrex, Inc.

K number K071978

View details →

HTN 2006-10-31

MINI TIGHTROPE REPAIR KIT, MODEL AR-8911DS

Applicant Arthrex, Inc.

K number K061925

View details →

HTN 2005-12-13

TIGHTROPE ACROMIOCLAVICULAR (AC) DEVICE, TITANIUM, STAINLESS STEEL , MODELS AR-2257, AR-TBD

Applicant Arthrex, Inc.

K number K052776

View details →

HTN 2005-02-18

BI-CORTICAL BIO-POST AND WASHER, MODEL AR-1367B

Applicant Arthrex, Inc.

K number K043145

View details →

HTN 2005-02-17

RESOFIX BIOABSORBABLE EXPANSION BOLT

Applicant Resofix, Inc.

K number K043411

View details →

HTN 2005-02-16

TIGHTROPE SYNDESMOSIS REPAIR KIT, TITANIUM, MODEL AR-8920DS; STAINLESS STEEL. MODEL AR-8921DS

Applicant Arthrex, Inc.

K number K043248

View details →

HTN 2004-03-23

BONE-LOK HP WASHER

Applicant Triage Medical, Inc.

K number K040250

View details →

HTN 2003-04-01

ODI 7.0MM CANNULATED SCREW SYSTEM

Applicant Orthopedic Designs, Inc.

K number K030619

View details →

HTN 2002-12-18

BI-CORTICAL BIO POST AND WASHER, MODEL AR-1367B

Applicant Arthrex, Inc.

K number K023119

View details →

HTN 2002-02-08

SYNTHES METALLIC SPIKED WASHERS

Applicant Synthes (Usa)

K number K013806

View details →

HTN 2002-01-30

SPIKED WASHER

Applicant Synthes (Usa)

K number K011583

View details →

HTN 2001-02-08

CANNULATED SCREW SYSTEM

Applicant Pioneer Surgical Technology

K number K003496

View details →

HTN 1999-10-27

HEX BUTTON

Applicant Pioneer Surgical Technology

K number K992617

View details →

HTN 1999-04-29

SOFT TISSUE SUTURE WASHER

Applicant Depuy, Inc.

K number K991135

View details →

HTN 1998-12-18

DEPUY ORTHOTECH SPIKED WASHER

Applicant DePuy Orthopaedics, Inc.

K number K983906

View details →

HTN 1998-11-23

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

Applicant Special Devices, Inc.

K number K982354

View details →

HTN 1998-10-26

DEPUY ACE COMPOSITE LOCKING NUT

Applicant Depuy Ace Medical Co.

K number K983265

View details →

HTN 1998-04-27

SYNTHES SCHUHLI IMPLANT SYSTEM

Applicant Synthes (Usa)

K number K980944

View details →

HTN 1997-03-17

ACUMED SUTURE WASHER

Applicant Acu Med, Inc.

K number K965028

View details →

HTN 1996-11-15

CANCELLOUS SCREW WASHER

Applicant Orthopaedic Biosystems, Ltd.

K number K963420

View details →

HTN 1996-02-09

WASHER, BOLT, NUT, ORTHOPEDIC

Applicant Linvatec Corp.

K number K954682

View details →

HTN 1996-01-17

SUTURE WASHER

Applicant Acu Med, Inc.

K number K954148

View details →

HTN 1994-12-20

BONE SCREW WASHER

Applicant Acu Med, Inc.

K number K943782

View details →

HTN 1993-05-12

SYNTHES (USA) TITANIUM LOCKED SPIKED WASHER

Applicant Synthes (Usa)

K number K924455

View details →

HTN 1991-11-07

SPIKED WASHER

Applicant Synthes (Usa)

K number K914472

View details →

HTN 1991-09-10

T-BOLT AND NUT

Applicant Danek Medical, Inc.

K number K911306

View details →

HTN 1991-07-25

WYMAN SUTURE WASHER

Applicant Acu Med, Inc.

K number K910186

View details →

HTN 1991-07-24

SOFT TISSUE SUTURE WASHER/3 HOLE WASHER

Applicant Depuy, Inc.

K number K910229

View details →

HTN 1989-09-11

ACE ORTHOPAEDIC WASHERS

Applicant Buckman Co., Inc.

K number K895107

View details →

HTN 1988-04-27

ACROMED WASHERS

Applicant Buckman Co., Inc.

K number K881699

View details →

HTN 1987-12-11

ACE BONE SCREW NUT

Applicant Buckman Co., Inc.

K number K874669

View details →

HTN 1984-09-12

KAPP SPINAL BUTTON

Applicant Kapp Surgical Instrument, Inc.

K number K843368

View details →

HTN 1984-01-17

TECHMEDICA-HEWSON SHOULDER CLEAT

Applicant Techmedica, Inc.

K number K834411

View details →

↑