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.

Pin, Fixation, Smooth

FDA product code HTY · 189 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: 1977-09-22 – 2026-08-28

HTY 2026-08-28

Primal K-Wire (P99-193-1410)

Applicant Paragon 28, Inc.

K number K262722

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HTY 2025-12-29

ZipToe™ Hammertoe Fusion System

Applicant Toetal Solutions

K number K253325

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HTY 2025-09-19

Impact PEEK Union Nail System

Applicant Nvision Biomedical Technologies, Inc.

K number K252657

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HTY 2025-08-01

RONAVIS – FX (FX-001)

Applicant AIRS, Inc.

K number K250315

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HTY 2025-06-24

PediFlex™ Flexible Nail System

Applicant OrthoPediatrics Corp.

K number K251362

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HTY 2025-06-11

Impact PEEK Union Nail System

Applicant Nvision Biomedical Technologies

K number K250646

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HTY 2024-05-22

Biomet Kirschner Wires (K-Wires)

Applicant Biomet, Inc.

K number K241014

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HTY 2023-12-01

OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable Fixation Nail

Applicant OSSIO , Ltd.

K number K231272

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HTY 2023-09-14

Hammerdesis™ Interphalangeal Fusion System

Applicant Intelivation

K number K231147

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HTY 2023-09-13

OSSIOfiber® Cannulated Trimmable Fixation Nail

Applicant OSSIO , Ltd.

K number K230750

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HTY 2023-08-14

Electro-Spec Steri-Caps

Applicant Electro-Spec, Inc.

K number K231905

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HTY 2023-07-06

Tyber Medical Pin and Wire System (various)

Applicant Tyber Medical, LLC

K number K231339

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HTY 2022-09-06

Hammertoe Truss System (HTS)

Applicant 4Web Medical, Inc.

K number K221283

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HTY 2022-07-22

SECURE-LOCK

Applicant Xiros, Ltd.

K number K220906

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HTY 2022-02-17

Pacific Instruments Orthopedic Fixation Pins and Wires / Kirschner / Guide Wires

Applicant Pacific Instruments

K number K213982

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HTY 2022-01-04

restor3d Pin Implants

Applicant Restor3D

K number K211789

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HTY 2021-09-30

Small Bone Nailing System

Applicant Skeletal Dynamics, Inc.

K number K211439

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HTY 2021-05-04

CoLink Sfx Implant System

Applicant In2bones USA, LLC

K number K203698

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HTY 2021-02-05

LimaCorporate Kirschner Wire

Applicant Lima Corporate S.P.A.

K number K203475

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HTY 2021-01-29

PediFlex Flexible Nail System

Applicant OrthoPediatrics Corp.

K number K201838

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HTY 2021-01-06

OSSIOfiber Cannulated Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail, Cannulated Design

Applicant OSSIO , Ltd.

K number K203465

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HTY 2020-11-17

VeriFixx™ Small Bone Implant

Applicant Armis Biopharma, Inc.

K number K202777

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HTY 2020-10-16

OSSIOfiber™ Hammertoe Fixation System/OSSIOfiber™ Hammertoe Fixation Implant

Applicant OSSIO , Ltd.

K number K201803

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HTY 2020-08-05

Smart Toe II, X Fuse

Applicant Stryker GmbH

K number K201715

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HTY 2020-06-29

Arthrex DynaNite K-Wire

Applicant Arthrex, Inc.

K number K200068

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HTY 2020-03-06

OSSIOfiber™ Hammertoe Fixation System/OSSIOfiber™ Hammertoe Fixation Implant

Applicant OSSIO , Ltd.

K number K190652

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HTY 2019-07-23

Hammertoe Truss System (HTS)

Applicant 4Web, Inc.

K number K190926

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HTY 2019-05-03

Arthrex DynaNite® PIP (Hammertoe) Implant

Applicant Arthrex, Inc.

K number K190287

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HTY 2019-01-25

HammerToe Compression System

Applicant Paragon 28, Inc.

K number K183228

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HTY 2019-01-10

OSSIO™ Pin Product Family

Applicant OSSIO , Ltd.

K number K181180

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HTY 2018-05-18

A.M. Surgical Intramedullary Fixation Device

Applicant A.M. Surgical, Inc.

K number K180087

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HTY 2018-03-05

HammerTube System

Applicant Paragon 28

K number K171715

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HTY 2018-03-02

Footmotion HammerToe

Applicant Newclip Technics

K number K172485

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HTY 2018-01-19

DIP Arthrodesis System

Applicant In2bones Sas

K number K173616

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HTY 2017-12-14

WishBone K-Wire System

Applicant Wishbone Medical, Inc.

K number K173013

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HTY 2017-11-16

Orthofix MJ-FLEX THE NEW METAIZEAU NAIL

Applicant Orthofix Srl

K number K173051

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HTY 2017-07-20

dynaMX Intramedullary Implant

Applicant Arthrex, Inc.

K number K170326

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HTY 2017-06-20

Stryker SonicPin System

Applicant Stryker Trauma GmbH

K number K170418

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HTY 2017-05-08

Precifit Medical Kirschner Wires

Applicant Precifit Medical, Ltd.

K number K163327

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HTY 2016-09-16

Syntorr K-wire and Pin System

Applicant Syntorr, Inc.

K number K161489

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HTY 2016-06-01

Additive Orthopaedics Hammertoe Correction System

Applicant Additive Orthopaedics, LLC

K number K160264

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HTY 2016-04-26

StarFuse Interphalangeal Pin

Applicant Phalanx Innovations

K number K160194

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HTY 2016-03-09

S-Wire

Applicant Spinal Resources, Inc.

K number K152662

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HTY 2016-02-01

In2Bones Kirschner wire

Applicant In2bones Sas

K number K153204

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HTY 2016-01-13

IFS Fixation Scaffold System

Applicant Metric Medical Devices, Inc.

K number K152627

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HTY 2013-10-23

WMT IMPLANTABLE K-WIRE

Applicant Wrightmedicaltechnologyinc

K number K132895

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HTY 2013-10-16

SMOOTH OR THREADED METALLIC BONE FASTENER

Applicant Biomedical Ent., Inc.

K number K131640

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HTY 2013-05-17

RIGIDFIX CURVE ST ACL PLA CROSS PIN SYSTEM, RIGIDFIX CURVE ST ACL PEEK CROSS PIN SYSTEM

Applicant Depuy Mitek, A Johnson & Johnson Company

K number K130105

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HTY 2013-03-15

X-FIX DYNAMIC EXTERNAL DISTRACTOR

Applicant Arex USA, LLC

K number K122415

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HTY 2012-06-04

TRILLIANT SURGICAL K-WIRES

Applicant Trilliant Surgical, Ltd.

K number K121008

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HTY 2012-04-24

APEX KIRSCHNER WIRES AND STEINMANN PINS

Applicant Apex Tools & Orthopedics Co.

K number K121004

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HTY 2012-04-17

INTRAOSSEOUS FIXATION SYSTEM

Applicant Orthohelix Surgical Designs, Inc.

K number K120165

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HTY 2012-03-20

NEWDEAL INTERPHALANGEAL IMPLANT

Applicant Newdeal Sas

K number K103623

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HTY 2011-12-19

ACL TIGHTROPE,ACL TIGHTROPE DUUBLE BUNDLE

Applicant Arthrex, Inc.

K number K112990

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HTY 2011-12-12

ARROW-LOK DIGITAL SYSTEM

Applicant Arrowhead Medical Device Technologies, LLC

K number K112675

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HTY 2011-11-17

MEMOMETAL INTRA-MEDULLARY BONE FASTENER

Applicant Memometal Technologies

K number K112197

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HTY 2011-10-11

APEX KIRSCHNER WIRES AND STEINMANN PINS

Applicant Apex Tools & Orthopedics Co.

K number K112254

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HTY 2011-04-28

PCL TIGHTROPE

Applicant Arthrex, Inc.

K number K110123

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HTY 2011-02-28

VERTICOR K-WIRE SYSTEM

Applicant Verticor, Ltd.

K number K110047

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HTY 2010-12-28

ACL TIGHTROPE DOUBLE BUNDLE

Applicant Arthrex, Inc.

K number K101837

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HTY 2010-11-09

KIRSCHNER WIRES, STEINMAN PINS

Applicant Evergreen Orthopedic Research Lab

K number K102215

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HTY 2010-11-03

MEMOMETAL IMPLANTS (K-SNAP & TI-FUSE)

Applicant Memometal Technologies

K number K102072

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HTY 2010-10-29

ARROWHEAD FIXATION DEVICE

Applicant Arrow Products, Inc.

K number K100926

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HTY 2010-09-10

KIRSCHNER AND GUIDE WIRES

Applicant Smt Schilling Metalltechnik GmbH

K number K100736

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HTY 2010-08-17

LIGAMENTOTAXOR

Applicant Arex USA

K number K094043

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HTY 2010-06-23

ACL TIGHTROPE

Applicant Arthrex, Inc.

K number K100652

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HTY 2010-04-02

STRYKER SONICPIN SYSTEM

Applicant Howmedica Osteonics Corp.

K number K091955

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HTY 2010-02-19

HAMMERLOCK

Applicant Biomedical Ent., Inc.

K number K091951

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HTY 2009-09-23

APTUS K-WIRE SYSTEM

Applicant Medartis AG

K number K092038

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HTY 2009-03-18

BIOPRO K-WIRE, MODELS 16863, 17231, 17232, 18577, 18682-18685

Applicant Biopro, Inc.

K number K083490

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HTY 2008-10-17

ORTHOPEDIATRICS PEDIFLEX FLEXIBLE NAIL SYSTEM

Applicant OrthoPediatrics Corp.

K number K082375

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HTY 2008-10-10

STARR FRAME STEINMANN PIN

Applicant Starr Frame, LLC

K number K082017

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HTY 2008-06-24

ACTIVATM PRODUCT GROUP INCLUDING BIOABSORBABLE DEVICES ACTIVAPIN FUSION, ACTIVANAILTM CONICALTM

Applicant Bioretec, Ltd.

K number K080879

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HTY 2008-06-03

ORTHOPEDIATRICS PEDIFLEX FLEXIBLE NAIL SYSTEM

Applicant Orthopediatrics, LLC

K number K081097

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HTY 2008-05-13

OSTEOTRANS-OT PIN

Applicant Takiron Co., Ltd.

K number K073311

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HTY 2008-03-24

BONE FIXATION WIRE (KIRSCHNER WIRE)

Applicant Signal Medical Corp.

K number K073674

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HTY 2007-12-19

ARC SURGICAL BIOTRAK PIN SYSTEM

Applicant Arc Surgical, LLC

K number K071616

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HTY 2007-08-31

ACTIVAPIN, NEXFIX RFS PIN, NEXFIX RESORBABLE FIXATION SYSTEM (RFS)

Applicant Bioretec, Ltd.

K number K071863

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HTY 2007-07-26

MEMOMETAL INTRA-MEDULLARY BONE FASTENER, MODELS SMART TOE / X-FUSE

Applicant Memometal Technologies

K number K070598

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HTY 2007-07-13

ORTHOPRO STEINMAN PINS AND KIRSCHNER WIRES

Applicant Orthopro, LLC

K number K070555

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HTY 2007-05-25

KMEDIC INTERNAL/EXTERNAL FIXATION DEVICES

Applicant Teleflex Medical

K number K070561

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HTY 2007-03-06

ARTHREX CROSSPIN, MODEL AR-1964P

Applicant Arthrex, Inc.

K number K063719

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HTY 2006-07-18

STORM OPERATING KIT, MODEL 1-10-0

Applicant Intelligent Orthopaedics, Ltd.

K number K061607

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HTY 2006-07-06

ACTIVAPIN

Applicant Bioretec, Ltd.

K number K061164

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HTY 2006-04-28

DSI PINS AND WIRES

Applicant Delta Surgical Instruments, Inc.

K number K060654

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HTY 2006-02-22

TRANSET SYSTEM

Applicant Bonutti Research, Inc.

K number K060283

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HTY 2005-11-03

ARTHREX K-WIRE ,THREADED MODELS AR-8990 TO 899X, AR-8991T TO AR-899XT

Applicant Arthrex, Inc.

K number K052736

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HTY 2005-08-10

SBI K-WIRES

Applicant Small Bone Innovations, LLC

K number K051605

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HTY 2005-05-27

ARTHREX BIO-PIN

Applicant Arthrex, Inc.

K number K050259

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HTY 2005-04-18

REFIX PIN (PLLA), MODELS 2070L, 2770L, 3570L, 4570L; (PLGA), MODELS 2070LG, 2770LG, 3570LG, 4570LG

Applicant Xtremi-T, LLC

K number K043339

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HTY 2005-03-07

MODIFICATION TO: INION OTPS BIODEGRADABLE PIN

Applicant Inion , Ltd.

K number K050275

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HTY 2005-01-19

PINN-ACL CROSSPIN

Applicant Linvatec Corp.

K number K043106

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HTY 2004-07-30

HUMERAL STAPLE

Applicant Smith & Nephew, Inc.

K number K041355

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HTY 2004-07-30

MODIFICATION TO SMALL BONE FIXATION SYSTEM

Applicant Hand Innovations, Inc.

K number K041157

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HTY 2004-06-10

MODIFICATION TO SMARTPIN

Applicant Linvatec Biomaterials, Inc.

K number K041288

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HTY 2004-05-25

ARTHROTEK LACTONAIL

Applicant Arthrotek, Inc.

K number K040500

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HTY 2004-02-25

TRANSET FRACTURE FIXATION SYSTEM

Applicant Bonutti Research, Inc.

K number K033717

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HTY 2004-02-20

HANSSON PIN SYSTEM

Applicant Howmedica Osteonics Corp.

K number K033968

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HTY 2004-01-15

SMALL BONE FIXATION SYSTEM

Applicant Hand Innovations, Inc.

K number K033406

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HTY 2004-01-15

BIODHOC

Applicant Future Medical Systems, SA

K number K024185

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