Orthopedic

HTY · Pin, Fixation, Smooth

Orthopedic · 21 CFR 888.3040 · Class 2

Overview

Product CodeHTY
Device NamePin, Fixation, Smooth
Regulation21 CFR 888.3040
Device ClassClass 2
Review PanelOrthopedic
ImplantYes

Identification

A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.

Classification Rationale

Class II.

Cleared Devices (204)

RecordDevice NameApplicantDecision DateDecision
K253325ZipToe™ Hammertoe Fusion SystemToetal SolutionsDec 29, 2025SESE
K252657Impact PEEK Union Nail SystemNvision Biomedical Technologies, Inc.Sep 19, 2025SESE
K250315RONAVIS – FX (FX-001)AIRS, Inc.Aug 1, 2025SESE
K251362PediFlex™ Flexible Nail SystemOrthoPediatrics Corp.Jun 24, 2025SESE
K250646Impact PEEK Union Nail SystemNvision Biomedical TechnologiesJun 11, 2025SESE
K241014Biomet Kirschner Wires (K-Wires)Biomet, Inc.May 22, 2024SESE
K231272OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable Fixation NailOSSIO , Ltd.Dec 1, 2023SESE
K231147Hammerdesis™ Interphalangeal Fusion SystemIntelivationSep 14, 2023SESE
K230750OSSIOfiber® Cannulated Trimmable Fixation NailOSSIO , Ltd.Sep 13, 2023SESE
K231905Electro-Spec Steri-CapsElectro-Spec, Inc.Aug 14, 2023SESE
K231339Tyber Medical Pin and Wire System (various)Tyber Medical, LLCJul 6, 2023SESE
K221283Hammertoe Truss System (HTS)4Web Medical, Inc.Sep 6, 2022SESE
K220906SECURE-LOCKXiros, Ltd.Jul 22, 2022SESE
K213982Pacific Instruments Orthopedic Fixation Pins and Wires / Kirschner / Guide WiresPacific InstrumentsFeb 17, 2022SESE
K211789restor3d Pin ImplantsRestor3DJan 4, 2022SESE
K211439Small Bone Nailing SystemSkeletal Dynamics, Inc.Sep 30, 2021SESE
K203698CoLink Sfx Implant SystemIn2bones USA, LLCMay 4, 2021SESE
K203475LimaCorporate Kirschner WireLima Corporate S.P.A.Feb 5, 2021SESE
K201838PediFlex Flexible Nail SystemOrthoPediatrics Corp.Jan 29, 2021SESE
K203465OSSIOfiber Cannulated Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail, Cannulated DesignOSSIO , Ltd.Jan 6, 2021SESE
K202777VeriFixx™ Small Bone ImplantArmis Biopharma, Inc.Nov 17, 2020SESE
K201803OSSIOfiber™ Hammertoe Fixation System/OSSIOfiber™ Hammertoe Fixation ImplantOSSIO , Ltd.Oct 16, 2020SESE
K201715Smart Toe II, X FuseStryker GmbHAug 5, 2020SESE
K200068Arthrex DynaNite K-WireArthrex, Inc.Jun 29, 2020SESE
K190652OSSIOfiber™ Hammertoe Fixation System/OSSIOfiber™ Hammertoe Fixation ImplantOSSIO , Ltd.Mar 6, 2020SESE
K190926Hammertoe Truss System (HTS)4Web, Inc.Jul 23, 2019SESE
K190287Arthrex DynaNite® PIP (Hammertoe) ImplantArthrex, Inc.May 3, 2019SESE
K183228HammerToe Compression SystemParagon 28, Inc.Jan 25, 2019SESE
K181180OSSIO™ Pin Product FamilyOSSIO , Ltd.Jan 10, 2019SESE
K180087A.M. Surgical Intramedullary Fixation DeviceA.M. Surgical, Inc.May 18, 2018SESE
K171715HammerTube SystemParagon 28Mar 5, 2018SESE
K172485Footmotion HammerToeNewclip TechnicsMar 2, 2018SESE
K173616DIP Arthrodesis SystemIn2bones SasJan 19, 2018SESE
K173013WishBone K-Wire SystemWishbone Medical, Inc.Dec 14, 2017SESE
K173051Orthofix MJ-FLEX THE NEW METAIZEAU NAILOrthofix SrlNov 16, 2017SESE
K170326dynaMX Intramedullary ImplantArthrex, Inc.Jul 20, 2017SESE
K170418Stryker SonicPin SystemStryker Trauma GmbHJun 20, 2017SESE
K163327Precifit Medical Kirschner WiresPrecifit Medical, Ltd.May 8, 2017SESE
K161489Syntorr K-wire and Pin SystemSyntorr, Inc.Sep 16, 2016SESE
K160264Additive Orthopaedics Hammertoe Correction SystemAdditive Orthopaedics, LLCJun 1, 2016SESE
K160194StarFuse Interphalangeal PinPhalanx InnovationsApr 26, 2016SESE
K152662S-WireSpinal Resources, Inc.Mar 9, 2016SESE
K153204In2Bones Kirschner wireIn2bones SasFeb 1, 2016SESE
K152627IFS Fixation Scaffold SystemMetric Medical Devices, Inc.Jan 13, 2016SESE
K151876Bio2 Fusion Implant SystemBio2 Technologies, Inc.Dec 30, 2015SESE
K142478opti-ToeGraham Medical Technologies, LLC (D.B.A.Gramedica)May 29, 2015SESE
K150626Rush Medullary PinsZimmer, Inc.May 1, 2015SESE
K150416ProCinch Adjustable Loop DeviceStryker EndoscopyApr 17, 2015SESE
K143702Arthrex Blunt Tip Screws with Fiber TapeArthrex, Inc.Apr 9, 2015SESE
K143049LYNC intramedullary implantNovastepFeb 19, 2015SESE
K143618Kirschner Wires, Steinmann PinsZimmer, Inc.Feb 6, 2015SESE
K143063Stryker SonicPin System, Stryker SonicAnchor SystemStryker Trauma GmbHJan 27, 2015SESE
K141714PRO-TOE X-FLEX HAMMERTOE FIXATION SYSTEMWrightmedicaltechnologyincOct 24, 2014SESE
K142134C-WIRE DOUBLE ENDED ORTHOPEDIC WIRESConmed Corporation, LargoSep 12, 2014SESE
K141004INTRAOSSEOUS FIXATION SYSTEMOrthohelix Surgical Designs, Inc.Aug 21, 2014SESE
K141577ARTHREX PIP DARTArthrex, Inc.Jul 18, 2014SESE
K133932INION FREEDOMPINInion OYApr 11, 2014SESE
K133477TOEGRIP, IMPLANT FOR PROXIMAL INTER-PHALANGEAL ARTHRODESISSynchro MedicalFeb 10, 2014SESE
K133950ACTIVAPIN HT, FUSE LINK (PRIVATE LABLED FOR FOOTMIND, INC.)Bioretec, Ltd.Jan 22, 2014SESE
K133520HAMMERLOCK 2Biomedical Enterprises, Inc.Jan 9, 2014SESE
K132895WMT IMPLANTABLE K-WIREWrightmedicaltechnologyincOct 23, 2013SESE
K131640SMOOTH OR THREADED METALLIC BONE FASTENERBiomedical Ent., Inc.Oct 16, 2013SESE
K130105RIGIDFIX CURVE ST ACL PLA CROSS PIN SYSTEM, RIGIDFIX CURVE ST ACL PEEK CROSS PIN SYSTEMDepuy Mitek, A Johnson & Johnson CompanyMay 17, 2013SESE
K122415X-FIX DYNAMIC EXTERNAL DISTRACTORArex USA, LLCMar 15, 2013SESE
K121008TRILLIANT SURGICAL K-WIRESTrilliant Surgical, Ltd.Jun 4, 2012SESE
K121004APEX KIRSCHNER WIRES AND STEINMANN PINSApex Tools & Orthopedics Co.Apr 24, 2012SESE
K120165INTRAOSSEOUS FIXATION SYSTEMOrthohelix Surgical Designs, Inc.Apr 17, 2012SESE
K103623NEWDEAL INTERPHALANGEAL IMPLANTNewdeal SasMar 20, 2012SESE
K112990ACL TIGHTROPE,ACL TIGHTROPE DUUBLE BUNDLEArthrex, Inc.Dec 19, 2011SESE
K112675ARROW-LOK DIGITAL SYSTEMArrowhead Medical Device Technologies, LLCDec 12, 2011SESE
K112197MEMOMETAL INTRA-MEDULLARY BONE FASTENERMemometal TechnologiesNov 17, 2011SESE
K112254APEX KIRSCHNER WIRES AND STEINMANN PINSApex Tools & Orthopedics Co.Oct 11, 2011SESE
K110123PCL TIGHTROPEArthrex, Inc.Apr 28, 2011SESE
K110047VERTICOR K-WIRE SYSTEMVerticor, Ltd.Feb 28, 2011SESE
K101837ACL TIGHTROPE DOUBLE BUNDLEArthrex, Inc.Dec 28, 2010SESE
K102215KIRSCHNER WIRES, STEINMAN PINSEvergreen Orthopedic Research LabNov 9, 2010SESE
K102072MEMOMETAL IMPLANTS (K-SNAP & TI-FUSE)Memometal TechnologiesNov 3, 2010SESE
K100926ARROWHEAD FIXATION DEVICEArrow Products, Inc.Oct 29, 2010SESE
K100736KIRSCHNER AND GUIDE WIRESSmt Schilling Metalltechnik GmbHSep 10, 2010SESE
K094043LIGAMENTOTAXORArex USAAug 17, 2010SESE
K100652ACL TIGHTROPEArthrex, Inc.Jun 23, 2010SESE
K091955STRYKER SONICPIN SYSTEMHowmedica Osteonics Corp.Apr 2, 2010SESE
K091951HAMMERLOCKBiomedical Ent., Inc.Feb 19, 2010SESE
K092038APTUS K-WIRE SYSTEMMedartis AGSep 23, 2009SESE
K083490BIOPRO K-WIRE, MODELS 16863, 17231, 17232, 18577, 18682-18685Biopro, Inc.Mar 18, 2009SESE
K082375ORTHOPEDIATRICS PEDIFLEX FLEXIBLE NAIL SYSTEMOrthoPediatrics Corp.Oct 17, 2008SESE
K082017STARR FRAME STEINMANN PINStarr Frame, LLCOct 10, 2008SESE
K080879ACTIVATM PRODUCT GROUP INCLUDING BIOABSORBABLE DEVICES ACTIVAPIN FUSION, ACTIVANAILTM CONICALTMBioretec, Ltd.Jun 24, 2008SESE
K081097ORTHOPEDIATRICS PEDIFLEX FLEXIBLE NAIL SYSTEMOrthopediatrics, LLCJun 3, 2008SESE
K073311OSTEOTRANS-OT PINTakiron Co., Ltd.May 13, 2008SESE
K073674BONE FIXATION WIRE (KIRSCHNER WIRE)Signal Medical Corp.Mar 24, 2008SESE
K071616ARC SURGICAL BIOTRAK PIN SYSTEMArc Surgical, LLCDec 19, 2007SESE
K071863ACTIVAPIN, NEXFIX RFS PIN, NEXFIX RESORBABLE FIXATION SYSTEM (RFS)Bioretec, Ltd.Aug 31, 2007SESE
K070598MEMOMETAL INTRA-MEDULLARY BONE FASTENER, MODELS SMART TOE / X-FUSEMemometal TechnologiesJul 26, 2007SESE
K070555ORTHOPRO STEINMAN PINS AND KIRSCHNER WIRESOrthopro, LLCJul 13, 2007SESE
K070561KMEDIC INTERNAL/EXTERNAL FIXATION DEVICESTeleflex MedicalMay 25, 2007SESE
K063719ARTHREX CROSSPIN, MODEL AR-1964PArthrex, Inc.Mar 6, 2007SESE
K061607STORM OPERATING KIT, MODEL 1-10-0Intelligent Orthopaedics, Ltd.Jul 18, 2006SESE
K061164ACTIVAPINBioretec, Ltd.Jul 6, 2006SESE
K060654DSI PINS AND WIRESDelta Surgical Instruments, Inc.Apr 28, 2006SESE
K060283TRANSET SYSTEMBonutti Research, Inc.Feb 22, 2006SESE
K052736ARTHREX K-WIRE ,THREADED MODELS AR-8990 TO 899X, AR-8991T TO AR-899XTArthrex, Inc.Nov 3, 2005SESE
K051605SBI K-WIRESSmall Bone Innovations, LLCAug 10, 2005SESE
K050259ARTHREX BIO-PINArthrex, Inc.May 27, 2005SESE
K043339REFIX PIN (PLLA), MODELS 2070L, 2770L, 3570L, 4570L; (PLGA), MODELS 2070LG, 2770LG, 3570LG, 4570LGXtremi-T, LLCApr 18, 2005SESE
K050275MODIFICATION TO: INION OTPS BIODEGRADABLE PINInion , Ltd.Mar 7, 2005SESE
K043106PINN-ACL CROSSPINLinvatec Corp.Jan 19, 2005SESE
K041355HUMERAL STAPLESmith & Nephew, Inc.Jul 30, 2004SESE
K041157MODIFICATION TO SMALL BONE FIXATION SYSTEMHand Innovations, Inc.Jul 30, 2004SESE
K041288MODIFICATION TO SMARTPINLinvatec Biomaterials, Inc.Jun 10, 2004SESE
K040500ARTHROTEK LACTONAILArthrotek, Inc.May 25, 2004SESE
K033717TRANSET FRACTURE FIXATION SYSTEMBonutti Research, Inc.Feb 25, 2004SESE
K033968HANSSON PIN SYSTEMHowmedica Osteonics Corp.Feb 20, 2004SESE
K033406SMALL BONE FIXATION SYSTEMHand Innovations, Inc.Jan 15, 2004SESE
K024185BIODHOCFuture Medical Systems, SAJan 15, 2004SESE
K032687ACE NANCY NAILDePuy Orthopaedics, Inc.Oct 6, 2003SESE
K031712INION OTPS BIODEGRADABLE PINInion , Ltd.Aug 28, 2003SESE
K031083OPUS MAGNUM IMPLANT SYSTEM, MODEL OM-1500Opus Medical, Inc.Jun 12, 2003SESE
K030665BONE WIREStork Instrumente GmbHMar 25, 2003SESE
K022597K-FIXNew Deal, S.A.Nov 1, 2002SESE
K022599NEWDEAL K WIRENew Deal, S.A.Oct 30, 2002SESE
K0225312MM PEDIATRIC FLEX NAILBiomet, Inc.Aug 26, 2002SESE
K013888FIXATION (STEINMANN) PINSMiltex, Inc.May 1, 2002SESE
K014305RESORBABLE LACTOSORB-L ACL CROSSPINArthrotek, Inc.Mar 29, 2002SESE
K013781RIDIDFIX 2.7MM BTB CROSS PIN KITMitek ProductsFeb 6, 2002SESE
K013424INTRAMEDULLARY FIXATION SYSTEM FOR THE HANDHand Innovations, Inc.Dec 20, 2001SESE
K012125OPUS MAGNUM ANCHOR & INSERTEROpus Medical, Inc.Sep 17, 2001SESE
K012161FLEX-NAILSFixano SAAug 24, 2001SESE
K011522RESORBABLE BONE PINSBiomet, Inc.Jul 31, 2001SESE
K010983PLLA PINBionx Implants, Inc.Jun 13, 2001SESE
K010479MULTITAK CONICAL TIP BONE SOFT TISSUE SUTURE ANCHORBonutti Research, Inc.May 8, 2001SESE
K003527MODIFICATION TO SYNTHES (USA) POLYPINSynthes (Usa)Apr 9, 2001SESE
K003659PLGA PIN, MODEL 171120,171140,171520,171540,171560,172020,172040,172060,173240,173260Bionx Implants, Inc.Feb 20, 2001SESE
K002125PINS AND WIRESImplant Resource, Inc.Oct 11, 2000SESE
K991971ARTHREX CHONDRAL DART, MODEL AR-4005B-18Arthrex, Inc.Aug 4, 2000SESE
K994232PHALANGEAL FIXATION SYSTEMMedcanica, Inc.Mar 1, 2000SESE
K991064METACARPAL FIXATION SYSTEMMedcanica, Inc.Jun 23, 1999SESE
K990291LACTOSORB BONE PINBiomet, Inc.Mar 23, 1999SESE
K983121NON-STERILE KIRSCHNER WIRES AND STEINMANN PINS, MODELS #'S 290-101/160, 290-201/216, 290-060/330, 290-161/220Syntec Scientific Corp.Oct 5, 1998SESE
K982719THE BONE TIESurgicraft , Ltd.Sep 25, 1998SESE
K980854RETROGRADE PEDIATRIC NAILEncore Orthopedics, Inc.Aug 11, 1998SESE
K974341MITEK BTB ABSORBABLE (PLA) CROSS PINMitek ProductsApr 16, 1998SESE
K974291MITEK BTB ABSORBABLE (PLA) CROSS PINMitek ProductsMar 5, 1998SESE
K973240SYNTHES PROXIMAL FEMORAL NAIL(PFN) SYSTEM MODIFICATIONSynthes (Usa)Nov 20, 1997SESE
K971962OSTEO KIRSCHNER WIRESOsteonics Corp.Aug 11, 1997SESE
K971783SYNTHES ELASTIC INTRAMEDULLARY NAIL (EIN) SYSTEMSynthes (Usa)Jul 18, 1997SESE
K971453ORTHOTEC K-CAP SYSTEMOrthotechJun 24, 1997SESE
K961608SYNTHES (U.S.A.) POLYPINSynthes (Usa)May 9, 1997SESE
K970733SYNTHES TITANIUM DIASTAL FEMORAL NAIL (TI DFN) SYSTEMSynthes (Usa)Apr 2, 1997SESE
K970036FIXATION PIN OR RODUnited States Surgical, A Division of Tyco HealthcMar 25, 1997SESE
K970013BIORIGID NAIL TIBIAAap GmbH and Co. Betriebs KGMar 13, 1997SESE
K964500ACUMED TENSION BAND PINAcu Med, Inc.Dec 9, 1996SESE
K964087BLOCK STOP WIRESFerguson MedicalNov 25, 1996SESE
K963367RMS K-WIRERms Div.Oct 30, 1996SESE
K961522KIRSCHNER WIRE (K-WIRE) AND STEINMANN PINSynvasive Technology, Inc.Sep 23, 1996SESE
K960642NANCY NAILLandos, Inc.May 17, 1996SESE
K960483STEINMAN PINAmerican Medical Specialties, Inc.Apr 9, 1996SESE
K960482K-WIREAmerican Medical Specialties, Inc.Apr 9, 1996SESE
K960385STERILE KIRSCHNER WIRES AND STEINMANN PINSDepuy, Inc.Mar 27, 1996SESE
K955806HOWMEDICA BIOABSORBABLE PINHowmedica, Inc.Feb 15, 1996SESE
K954543GO UNIVERSALK-WIRE FLUTED DRILLGenesis Orthopedics, Inc.Dec 8, 1995SN
K953194LACTOSORB BONE PINBiomet, Inc.Oct 31, 1995SN
K954001SPETZLER PINHowmedica Corp.Oct 26, 1995SESE
K943856FIXATION PINS/WIRESAcu Med, Inc.Jul 6, 1995SESE
K945639SPETZLER PINHowmedica Corp.Apr 14, 1995SN
K940673J.B.S. SELF-TAPPING THREADED PINJ.B.S., S.A.Nov 14, 1994SESE
K940669J.B.S. B.A.C. PINJ.B.S., S.A.Nov 14, 1994SESE
K940666JBS SMOOTH FIXATION PINJ.B.S., S.A.Nov 14, 1994SESE
K941434K-WIRES AND STEINMANN PINSOmega Surgical Instruments, Inc.Oct 3, 1994SESE
K925098BIOFIX ABSORBABLE SELF-REINFORCED POLY-L-LACTIDEBioscience, Inc.Jul 19, 1994SN
K931836ACUFEX SMOOTH AND THREADED PINSAcufex Microsurgical, Inc.Jun 28, 1994SESE
K931697FIXATION PINOrthologic Corp.May 12, 1994SESE
K930969BAUMER PINSBaumer Ortopedia , Ltd.Mar 29, 1994SESE
K932348ORTHOPEDIC SMOOTH PIN FIXATIONOsteomed Corp.Mar 1, 1994SESE
K940109TAVA K-WIRETava Surgical InstrumentsFeb 22, 1994SESE
K922766ACUFEX BIOFIX ABSORBABLE FIXATION ROD-MODIFICATIONAcufex Microsurgical, Inc.Jul 9, 1993SESK
K925301OTI ORTHOPEDIC FASTENER SYSTEMOsteo Technology, Inc.Mar 16, 1993SESE
K922194OSTEO STEINMANN PINOsteo AGJul 23, 1992SESE
K922193OSTEO KIRSCHNER WIREOsteo AGJul 23, 1992SESE
K911375G-PINDr.M.A.GalluzzoSep 23, 1991SESE
K911505FIXATION WIRESimpex, Inc.Apr 12, 1991SESE
K911452FIXATION PINSimpex, Inc.Apr 12, 1991SESE
K905345K-WIREO'Tec Corp.Dec 11, 1990SESE
K905341RUSH PINO'Tec Corp.Dec 11, 1990SESE
K905337STEINMAN PINO'Tec Corp.Dec 11, 1990SESE
K903265STEINMAN PINOnyx Medical Corp.Jul 30, 1990SESE
K903264K-WIREOnyx Medical Corp.Jul 30, 1990SESE
K901273L.M.S. SELF-DETACHABLE BROACH WITH STOPMed-Tek Corp.Jun 5, 1990SESE
K890902BIOFIX* BIODEGRADABLE FIXATION RODDavis & Geck, Inc.Nov 3, 1989SESE
K895079ACE BEADED K-WIRES ACE OLIVE WIRESBuckman Co., Inc.Sep 13, 1989SESE
K874913ORTHOMET PIN SYSTEMOrthomet, Inc.Jan 7, 1988SESE
K872842PIN, HIP, KNOWLESMilitary Engineering, Inc.Aug 7, 1987SESE
K864912PDS (POLYDIOXANON) ABSORBABLE PINJohnson & Johnson Professionals, Inc.Jul 9, 1987SESE
K863734STEINMANN(THREADED/CALIBRATED),KNOWLES&HOGIE PINSMicro-Aire Surgical Instruments, Inc.Oct 20, 1986SESE
K863119CANNULATED LAG SCREWSDowns Surgical , Ltd.Sep 3, 1986SESE
K860590ACE UNILATERAL FIXATORBuckman Co., Inc.Mar 7, 1986SESE
K852563PIN SET, BONE RUSH, 7-1/4 THRU 18-1/2 INCHES LONGThe Huxley Instrument Corp.Jun 28, 1985SESE
K852562PIN SET, BONE, RUSH, 4 THRU 10 1/2 INCHES LONGThe Huxley Instrument Corp.Jun 28, 1985SESE
K852561PIN SET, BONEM, RUSH, 1 THRU 10 INCHES LONGThe Huxley Instrument Corp.Jun 28, 1985SESE
K852560PINSET, BONE, RUSH 9-1/2 THRU 20-3/4 INCHES LONGThe Huxley Instrument Corp.Jun 28, 1985SESE

Top Applicants

Innolitics

Panel 1

/
Sort by
Ready

Predicate graph will load when search results are available.

Embedding visualization will load when search results are available.

PDF viewer will load when search results are available.

Loading panels...

Select an item from the tree

Click any panel, subpart, regulation, product code, or device to see details here.

Section Matches

Results will appear here.

Product Code Matches

Results will appear here.

Special Control Matches

Results will appear here.

Loading collections...