Atlas FDA

HTY

204 FDA 510(k) clearances · Product code

86 daysmedian time to decision
233 days90th percentile
204clearances measured

FDA profile

Official device name
Pin, Fixation, Smooth
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3040
Medical specialty
Orthopedic
Flags
Implant
Adverse events (MAUDE)
2021: 148 · 2022: 96 · 2023: 153 · 2024: 297 · 2025: 39 · 2026: 26
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
ZipToe™ Hammertoe Fusion System (K253325)Toetal Solutions2025-12-29
Impact PEEK Union Nail System (K252657)Nvision Biomedical Technologies, Inc.2025-09-19
RONAVIS – FX (FX-001) (K250315)AIRS, Inc.2025-08-01
PediFlex™ Flexible Nail System (K251362)OrthoPediatrics Corp.2025-06-24
Impact PEEK Union Nail System (K250646)Nvision Biomedical Technologies2025-06-11
Biomet Kirschner Wires (K-Wires) (K241014)Biomet, Inc.2024-05-22
OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable Fixation Nail (K231272)OSSIO , Ltd.2023-12-01
Hammerdesis™ Interphalangeal Fusion System (K231147)Intelivation2023-09-14
OSSIOfiber® Cannulated Trimmable Fixation Nail (K230750)OSSIO , Ltd.2023-09-13
Electro-Spec Steri-Caps (K231905)Electro-Spec, Inc.2023-08-14
Tyber Medical Pin and Wire System (various) (K231339)Tyber Medical, LLC2023-07-06
Hammertoe Truss System (HTS) (K221283)4Web Medical, Inc.2022-09-06
SECURE-LOCK (K220906)Xiros, Ltd.2022-07-22
Pacific Instruments Orthopedic Fixation Pins and Wires / Kirschner / Guide Wires (K213982)Pacific Instruments2022-02-17
restor3d Pin Implants (K211789)Restor3D2022-01-04
Small Bone Nailing System (K211439)Skeletal Dynamics, Inc.2021-09-30
CoLink Sfx Implant System (K203698)In2bones USA, LLC2021-05-04
LimaCorporate Kirschner Wire (K203475)Lima Corporate S.P.A.2021-02-05
PediFlex Flexible Nail System (K201838)OrthoPediatrics Corp.2021-01-29
OSSIOfiber Cannulated Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail, Cannulated Design (K203465)OSSIO , Ltd.2021-01-06
VeriFixx™ Small Bone Implant (K202777)Armis Biopharma, Inc.2020-11-17
OSSIOfiber™ Hammertoe Fixation System/OSSIOfiber™ Hammertoe Fixation Implant (K201803)OSSIO , Ltd.2020-10-16
Smart Toe II, X Fuse (K201715)Stryker GmbH2020-08-05
Arthrex DynaNite K-Wire (K200068)Arthrex, Inc.2020-06-29
OSSIOfiber™ Hammertoe Fixation System/OSSIOfiber™ Hammertoe Fixation Implant (K190652)OSSIO , Ltd.2020-03-06
Hammertoe Truss System (HTS) (K190926)4Web, Inc.2019-07-23
Arthrex DynaNite® PIP (Hammertoe) Implant (K190287)Arthrex, Inc.2019-05-03
HammerToe Compression System (K183228)Paragon 28, Inc.2019-01-25
OSSIO™ Pin Product Family (K181180)OSSIO , Ltd.2019-01-10
A.M. Surgical Intramedullary Fixation Device (K180087)A.M. Surgical, Inc.2018-05-18
HammerTube System (K171715)Paragon 282018-03-05
Footmotion HammerToe (K172485)Newclip Technics2018-03-02
DIP Arthrodesis System (K173616)In2bones Sas2018-01-19
WishBone K-Wire System (K173013)Wishbone Medical, Inc.2017-12-14
Orthofix MJ-FLEX THE NEW METAIZEAU NAIL (K173051)Orthofix Srl2017-11-16
dynaMX Intramedullary Implant (K170326)Arthrex, Inc.2017-07-20
Stryker SonicPin System (K170418)Stryker Trauma GmbH2017-06-20
Precifit Medical Kirschner Wires (K163327)Precifit Medical, Ltd.2017-05-08
Syntorr K-wire and Pin System (K161489)Syntorr, Inc.2016-09-16
Additive Orthopaedics Hammertoe Correction System (K160264)Additive Orthopaedics, LLC2016-06-01
StarFuse Interphalangeal Pin (K160194)Phalanx Innovations2016-04-26
S-Wire (K152662)Spinal Resources, Inc.2016-03-09
In2Bones Kirschner wire (K153204)In2bones Sas2016-02-01
IFS Fixation Scaffold System (K152627)Metric Medical Devices, Inc.2016-01-13
Bio2 Fusion Implant System (K151876)Bio2 Technologies, Inc.2015-12-30
opti-Toe (K142478)Graham Medical Technologies, LLC (D.B.A.Gramedica)2015-05-29
Rush Medullary Pins (K150626)Zimmer, Inc.2015-05-01
ProCinch Adjustable Loop Device (K150416)Stryker Endoscopy2015-04-17
Arthrex Blunt Tip Screws with Fiber Tape (K143702)Arthrex, Inc.2015-04-09
LYNC intramedullary implant (K143049)Novastep2015-02-19
Kirschner Wires, Steinmann Pins (K143618)Zimmer, Inc.2015-02-06
Stryker SonicPin System, Stryker SonicAnchor System (K143063)Stryker Trauma GmbH2015-01-27
PRO-TOE X-FLEX HAMMERTOE FIXATION SYSTEM (K141714)Wrightmedicaltechnologyinc2014-10-24
C-WIRE DOUBLE ENDED ORTHOPEDIC WIRES (K142134)Conmed Corporation, Largo2014-09-12
INTRAOSSEOUS FIXATION SYSTEM (K141004)Orthohelix Surgical Designs, Inc.2014-08-21
ARTHREX PIP DART (K141577)Arthrex, Inc.2014-07-18
INION FREEDOMPIN (K133932)Inion OY2014-04-11
TOEGRIP, IMPLANT FOR PROXIMAL INTER-PHALANGEAL ARTHRODESIS (K133477)Synchro Medical2014-02-10
ACTIVAPIN HT, FUSE LINK (PRIVATE LABLED FOR FOOTMIND, INC.) (K133950)Bioretec, Ltd.2014-01-22
HAMMERLOCK 2 (K133520)Biomedical Enterprises, Inc.2014-01-09
WMT IMPLANTABLE K-WIRE (K132895)Wrightmedicaltechnologyinc2013-10-23
SMOOTH OR THREADED METALLIC BONE FASTENER (K131640)Biomedical Ent., Inc.2013-10-16
RIGIDFIX CURVE ST ACL PLA CROSS PIN SYSTEM, RIGIDFIX CURVE ST ACL PEEK CROSS PIN SYSTEM (K130105)Depuy Mitek, A Johnson & Johnson Company2013-05-17
X-FIX DYNAMIC EXTERNAL DISTRACTOR (K122415)Arex USA, LLC2013-03-15
TRILLIANT SURGICAL K-WIRES (K121008)Trilliant Surgical, Ltd.2012-06-04
APEX KIRSCHNER WIRES AND STEINMANN PINS (K121004)Apex Tools & Orthopedics Co.2012-04-24
INTRAOSSEOUS FIXATION SYSTEM (K120165)Orthohelix Surgical Designs, Inc.2012-04-17
NEWDEAL INTERPHALANGEAL IMPLANT (K103623)Newdeal Sas2012-03-20
ACL TIGHTROPE,ACL TIGHTROPE DUUBLE BUNDLE (K112990)Arthrex, Inc.2011-12-19
ARROW-LOK DIGITAL SYSTEM (K112675)Arrowhead Medical Device Technologies, LLC2011-12-12
MEMOMETAL INTRA-MEDULLARY BONE FASTENER (K112197)Memometal Technologies2011-11-17
APEX KIRSCHNER WIRES AND STEINMANN PINS (K112254)Apex Tools & Orthopedics Co.2011-10-11
PCL TIGHTROPE (K110123)Arthrex, Inc.2011-04-28
VERTICOR K-WIRE SYSTEM (K110047)Verticor, Ltd.2011-02-28
ACL TIGHTROPE DOUBLE BUNDLE (K101837)Arthrex, Inc.2010-12-28
KIRSCHNER WIRES, STEINMAN PINS (K102215)Evergreen Orthopedic Research Lab2010-11-09
MEMOMETAL IMPLANTS (K-SNAP & TI-FUSE) (K102072)Memometal Technologies2010-11-03
ARROWHEAD FIXATION DEVICE (K100926)Arrow Products, Inc.2010-10-29
KIRSCHNER AND GUIDE WIRES (K100736)Smt Schilling Metalltechnik GmbH2010-09-10
LIGAMENTOTAXOR (K094043)Arex USA2010-08-17
ACL TIGHTROPE (K100652)Arthrex, Inc.2010-06-23
STRYKER SONICPIN SYSTEM (K091955)Howmedica Osteonics Corp.2010-04-02
HAMMERLOCK (K091951)Biomedical Ent., Inc.2010-02-19
APTUS K-WIRE SYSTEM (K092038)Medartis AG2009-09-23
BIOPRO K-WIRE, MODELS 16863, 17231, 17232, 18577, 18682-18685 (K083490)Biopro, Inc.2009-03-18
ORTHOPEDIATRICS PEDIFLEX FLEXIBLE NAIL SYSTEM (K082375)OrthoPediatrics Corp.2008-10-17
STARR FRAME STEINMANN PIN (K082017)Starr Frame, LLC2008-10-10
ACTIVATM PRODUCT GROUP INCLUDING BIOABSORBABLE DEVICES ACTIVAPIN FUSION, ACTIVANAILTM CONICALTM (K080879)Bioretec, Ltd.2008-06-24
ORTHOPEDIATRICS PEDIFLEX FLEXIBLE NAIL SYSTEM (K081097)Orthopediatrics, LLC2008-06-03
OSTEOTRANS-OT PIN (K073311)Takiron Co., Ltd.2008-05-13
BONE FIXATION WIRE (KIRSCHNER WIRE) (K073674)Signal Medical Corp.2008-03-24
ARC SURGICAL BIOTRAK PIN SYSTEM (K071616)Arc Surgical, LLC2007-12-19
ACTIVAPIN, NEXFIX RFS PIN, NEXFIX RESORBABLE FIXATION SYSTEM (RFS) (K071863)Bioretec, Ltd.2007-08-31
MEMOMETAL INTRA-MEDULLARY BONE FASTENER, MODELS SMART TOE / X-FUSE (K070598)Memometal Technologies2007-07-26
ORTHOPRO STEINMAN PINS AND KIRSCHNER WIRES (K070555)Orthopro, LLC2007-07-13
KMEDIC INTERNAL/EXTERNAL FIXATION DEVICES (K070561)Teleflex Medical2007-05-25
ARTHREX CROSSPIN, MODEL AR-1964P (K063719)Arthrex, Inc.2007-03-06
STORM OPERATING KIT, MODEL 1-10-0 (K061607)Intelligent Orthopaedics, Ltd.2006-07-18
ACTIVAPIN (K061164)Bioretec, Ltd.2006-07-06
DSI PINS AND WIRES (K060654)Delta Surgical Instruments, Inc.2006-04-28
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