Orthopedic

JDR · Staple, Fixation, Bone

Orthopedic · 21 CFR 888.3030 · Class 2

Overview

Product CodeJDR
Device NameStaple, Fixation, Bone
Regulation21 CFR 888.3030
Device ClassClass 2
Review PanelOrthopedic
ImplantYes

Identification

Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.

Classification Rationale

Class II.

Cleared Devices (231)

RecordDevice NameApplicantDecision DateDecision
K250712Linkt Compression Staple SystemTrax SurgicalMay 14, 2025SESE
K243888Medline UNITE® REFLEX® Hybrid Nitinol Implant SystemMedline Industries, LPApr 11, 2025SESE
K243742Arthrex DynaNite Nitinol StaplesArthrex, Inc.Jan 31, 2025SESE
K243658TMC Compression Implant SystemTreace Medical ConceptsDec 26, 2024SESE
K242415TMC Compression Implant SystemTreace Medical ConceptsSep 6, 2024SESE
K240212COGNiTiON™ Staple SystemOrtho Solutions UK , Ltd.Feb 23, 2024SESE
K232990A’TOMIC™ Nitinol Fixation SystemRmr Ortho, LLCJan 12, 2024SESE
K230724arcad® 2.0 Duo & Quadro osteosynthesis compressive staplesNovastepDec 4, 2023SESE
K232905Medline UNITE® REFLEX® Nitinol Staple KitMedline Industries, LPOct 19, 2023SESE
K232324StealthFix Intraosseous Fixation SystemMedartis, Inc.Aug 30, 2023SESE
K232387Treace Medical Concepts (TMC) Compression Implant SystemTreace Medical ConceptsAug 28, 2023SESE
K231493NITINEX Memory Compression StapleVilex, LLCAug 11, 2023SESE
K231885Medline UNITE® REFLEX® Nitinol Staple SystemMedline Industries, LPAug 9, 2023SESE
K231458Extremity StapleRestor3DAug 3, 2023SESE
K230550JAWS Nitinol Staple SystemParagon 28, Inc.May 11, 2023SESE
K223056JAWS Nitinol Staple SystemParagon 28, Inc.Feb 16, 2023SESE
K222645Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical ConceptsNov 21, 2022SESE
K221947Tyber Medical Staple Fixation System (various)Tyber Medical, LLCOct 20, 2022SESE
K220812DynaClip® Bone StapleMedShape, Inc.Aug 19, 2022SESE
K210582EasyClip® and EasyClip® XpressStryker GmbHJun 10, 2022SESE
K220181StealthFix Intraosseous Fixation SystemNextremity Solutions, Inc.Mar 22, 2022SESE
K203832FuseForce™ Flex Dynamic Compression SystemWright MedicalMay 7, 2021SESE
K210482Medline UNITE REFLEX Nitinol Staple SystemMedline Industries, Inc.Apr 22, 2021SESE
K210456Ligament StapleMedacta International S.A.Apr 12, 2021SESE
K203180Arthrex DynaNite Nitinol StaplesArthrex, Inc.Dec 16, 2020SESE
K193305DynaClip Bone StapleMedShape, Inc.Apr 23, 2020SESE
K192447Superelastic StapleNeosteoFeb 28, 2020SESE
K191463DePuy Synthes Hammertoe Continuous Compression ImplantSynthes (USA) Products, LLCFeb 26, 2020SESE
K191636APTUS Foot SystemMedartis AGAug 16, 2019SESE
K190722TriMAX Implant SystemCrossroads Extemity Systems, LLCAug 16, 2019SESE
K190166TriMed Nitinol Staple SystemTriMed, Inc.Jul 1, 2019SESE
K182943VERTEX Nitinol Staple SystemNvision Biomedical Technologies, LLCApr 4, 2019SESE
K182212Geo Staple SystemGramercy Extremity Orthopedics, LLCJan 11, 2019SESE
K181781DynaClipTM Bone StapleMedShape, Inc.Nov 5, 2018SESE
K181815DynaBridgeFusion Orthopedics, LLCOct 15, 2018SESE
K181866MotoCLIP/HiMAX Step Staple Implant SystemCrossroads Extremity Systems, LLCAug 9, 2018SESE
K180544DePuy Synthes Static StaplesSynthes (USA) Products, LLCJul 24, 2018SESE
K181410MotoCLIP/HiMAX Implant SystemCrossroads Extremity Systems, LLCJun 29, 2018SESE
K173775Clench Compression StapleF & A Foundation, LLC D.B.A. Reign MedicalApr 6, 2018SESE
K173693Orbitum Bone Staple Implant, X and VIOrthovestments, LLCFeb 23, 2018SESE
K172205ExoToe StapleExotoe, LLCJan 11, 2018SESE
K172052Arthrex DynaNite Nitinol StapleArthrex, Inc.Dec 13, 2017SESE
K172405SNIPER STAPLE SYSTEM, NON-STERILETrilliant SurgicalDec 11, 2017SESE
K171473Compressyn™ StapleDallen Medical, Inc.Nov 7, 2017SESE
K170923JAWS(TM) Nitinol Staple SystemParagon 28Jul 24, 2017SESE
K163226EPIC Extremely Small StapleEpic Extremely, LLCMay 16, 2017SESE
K162354Sniper Staple SystemTrilliant Surgical, Ltd.Apr 20, 2017SESE
K162321EasyClip XpressRestore Surgical, LLC Dba InstratekFeb 10, 2017SESE
K163440Stealth Staple SystemFirst Ray, LLCFeb 1, 2017SESE
K161587Memodyn StapleAustin & Associates, Inc./Telos Medical EquipmentFeb 1, 2017SESE
K161426NeoSpan Compression Staple Impant w/instrumentsIn2bones USA, LLCOct 24, 2016SESE
K160813EasyStepStryker GmbHJul 26, 2016SESE
K153622First Ray Internal Bone Staple SystemFirst Ray, LLCApr 8, 2016SESE
K153770OS2(R)-VP Varisation StapleIn2bones SasMar 21, 2016SESE
K153395OS2-C Compression StapleIn2bones SasFeb 18, 2016SESE
K153129dynaMX Tabbed StapleMx Orthopedics, Corp.Jan 28, 2016SESE
K151762PediatrOS RigidTack/FlexTackMerete Medical GmbHDec 28, 2015SESE
K151615TiTHON Staple with OsseoTi TechnologyBiomet Manufacturing CorpOct 2, 2015SESE
K151160Arcus Staple SystemNextremity Solutions, Inc.Sep 4, 2015SESE
K143622dynaMX Compression StapleMx Orthopedics, Corp.Jun 17, 2015SESE
K150125Elite Nitinol Fixation SystemBiomedical Enterprises, Inc.May 11, 2015SESE
K143323OS2-V Varisation StapleIn2bones SasFeb 26, 2015SESE
K143037SnapShot Fixation SystemBiomet Manufacturing CorpJan 20, 2015SESE
K142111ARCAD COMPRESSIVE OSTEOSYNTHESIS STAPLE, EXPRESS COMPRESSIVE OSTEOSYNTHESIS STAPLENovatsepDec 19, 2014SESE
K141263TOGGLELOC AND JUGGERLOC IMPLANTS/INSTRUMENTS/KITSBiomet Manufacturing CorpNov 19, 2014SESE
K142292Speed, Speed Shift, Speed Titan, Speed ArcBiomedical Enterprises, Inc.Nov 17, 2014SESE
K142727CrossCLIP Implant SystemOrthodiscovery Group, LLC(D.B.A. Crossroads Extremity SystemsOct 24, 2014SESE
K142148ORTHOHELIX STAPLE SYSTEMOrthohelix Surgical Designs, Inc.Aug 21, 2014SESE
K141550INSTAFIX SHAPE MEMORY FIXATION SYSTEMOt MedicalJul 11, 2014SESE
K140358COMPRESSYN STAPLEDallen Medical, Inc.Jun 2, 2014SESE
K133270SPEED ARCBiomedical Enterprises, Inc.Apr 17, 2014SESE
K133844SPEED TRIADBiomedical Ent., Inc.Apr 7, 2014SESE
K133780SPEED XLBiomedical Ent., Inc.Mar 19, 2014SESE
K133523STAPIX SUPERELASTIC IMPLANT BONE STAPLESInstratek, Inc.Feb 6, 2014SESE
K132875COMPRESSYN STAPLEDallen Medical, Inc.Dec 30, 2013SESE
K131061RESTORE BUNION CORRECTION SYSTEMNextremity SolutionsAug 28, 2013SESE
K130832ORTHOHELIX STAPLE SYSTEMOrthohelix Surgical Designs, Inc.Aug 15, 2013SESE
K124045FUSEFORCE IMPLANT SYSTEMSolana Surgical, LLCJul 10, 2013SESE
K124022SPEED SHIFTBiomedical Enterprises, Inc.May 14, 2013SESE
K123926METASURG NITINOL STAPLE IMPLANTMetasurgMay 3, 2013SESE
K122113MEMORY METAL STAPLES, EASYCLIPStryker Corp.Mar 12, 2013SESE
K122871COMPRESSYN STAPLEDallen Medical, Inc.Feb 7, 2013SESE
K123363SUPER STAPLE(TM) CLASSICMetric Medical Devices, Inc.Jan 3, 2013SESE
K112837VILEX EZ-STAPLE (MEMORY BONE FIXATION STAPLE)Vilex, Inc.Oct 9, 2012SESE
K102387MEDISCOPE COMPRESSIOPN STAPLE AND ACCESSORIESMediscope Manufacturing, Inc.Oct 24, 2011SESE
K102143SUSPENSION ACROMIOCLAVICULAR (AC) REPAIR SYSTEMSuspension Orthopaedic Solutions, LLCDec 8, 2010SESE
K102107OSSTAPLE CHILLBiomedical Ent., Inc.Sep 3, 2010SESE
K082215OSTEORAPTOR SUTURE ANCHORSmith & Nephew Inc., Endoscopy DivisionNov 3, 2008SESE
K081172COMPOSITE HITCH SUTURE ANCHORBiomet Manufacturing CorpJul 17, 2008SESE
K081098ENDOBUTTON CONTINUOUS LOOP (CL)Smith & Nephew Inc., Endoscopy DivisionJul 16, 2008SESE
K073281CAIS STAPLEDepuy Mitek, A Johnson & Johnson CompanyMay 2, 2008SESE
K080111ARTHREX COMPRESSION STAPLEArthrex, Inc.Feb 13, 2008SESE
K072298BIOPRO MEMORY STAPLE, MODELS 18062-18073Biopro, Inc.Oct 29, 2007SESE
K071477REVERTO 55 AND 37 SHAPE MEMORY STAPLESCore Essence Orthopaedics, LLCAug 15, 2007SESE
K071637INTRINSIC THERAPEUTICS FIXATION STAPLEIntrinsic Therapeutics IncorporatedAug 3, 2007SESE
K071479SBI STAFIXSmall Bone Innovations, Inc.Aug 2, 2007SESE
K071257MINI QUICKANCHOR AND QUICKANCHOR PLUS WITH ORTHOCORDDepuy Mitek, A Johnson & Johnson CompanyJun 29, 2007SESE
K070688NEXFIX COMPRESSION STAPLENexa Orthopedics, Inc.May 18, 2007SESE
K070033MEMOMETAL VARISATION, MODELS AV26-08, AV26-10, AV90-08 AND AV90-10Memometal TechnologiesMar 19, 2007SESE
K070031MEMOMETAL MEMORY STAPLESMemometal TechnologiesMar 19, 2007SESE
K063273PANALOK QUICKANCHOR PLUS, PANALOK RC QUICKANCHOR PLUS DUAL SUTURE, PANALOK ANCHORDepuy Miltek, A Johnson & Johnson Co.Nov 22, 2006SESE
K062734ADJUST-RIGHT FIXATION DEVICESValpo Orthopedic Technology, Inc.Nov 22, 2006SESE
K061776ARTHROTEK MAXFIRE MENISCAL REPAIR DEVICEArthrotek, Inc.Sep 25, 2006SESE
K062170BIOKNOTLESS AND LUPINE PLUS ANCHORSDepuy Mitek, A Johnson & Johnson CompanyAug 22, 2006SESE
K061798BIOPRO MEMORY STAPLEBiopro, Inc.Aug 21, 2006SESE
K0618012.8 & 3.5MM LACTOSCREW SUTURE ANCHORSArthrotek, Inc.Aug 7, 2006SESE
K061657HITCH LACTOSORB SUTURE ANCHORArthrotek, Inc.Jul 25, 2006SESE
K061389ALLTHREAD LACTOSORB SUTURE ANCHORArthrotek, Inc.Jul 19, 2006SESE
K060970AXYALOOP NONABSORBABLE BONE ANCHORAxya Medical, Inc.Jul 5, 2006SESE
K061594LARGE UNI-CLIP STAPLENew Deal, S.A.Jul 3, 2006SESE
K060746MEMORY STAPLEDePuy Orthopaedics, Inc.May 25, 2006SESE
K060553RC LOOP /DUAL ORTHOCORD SUTURE,RC LOOP W/ETHIBOND SUTURE,RC LOOP W/PANACRYL SUTUREDepuy Mitek, A Johnson & Johnson CompanyMay 4, 2006SESE
K060014INTELIFUSE, INC., WARMSYSTEM WITH STIMULINKSIntelifuse, Inc.Apr 3, 2006SESE
K052631SUPER QUICKANCHOR PLUS (WITH ORTHOCORD SUTURE)Depuy Mitek, A Johnson & Johnson CompanyOct 21, 2005SESE
K051989GII QUICKANCHOR PLUS WITH ORTHOCORD SUTUREDepuy Mitek, A Johnson & Johnson CompanyAug 5, 2005SESE
K051408INTELIFUSE, INC. WARM SYSTEM WITH STIMULINKSIntelifuse, Inc.Jun 29, 2005SESE
K043059COMPRESSION STAPLE AND SIMPLE STAPLEWrightmedicaltechnologyincJan 18, 2005SESE
K041988ARTHROTEK MENISCAL HYBRID DEVICEBiomet, Inc.Oct 20, 2004SESE
K041117PANALOK RC QUICKANCHOR PLUS, MODEL 212130, 212730; DUAL SUTURE PANALOK RC QUICKANCHOR PLLUS, MODELS 212132, 212732Depuy MitekMay 28, 2004SESE
K041116SUPER QUICKANCHOR PLUSDepuy MitekMay 28, 2004SESE
K041115GII QUICKANCHOR PLUSDepuy Mitek, A Johnson & Johnson CompanyMay 28, 2004SESE
K041064BIOKNOTLESS RC ANCHORDepuy MitekMay 13, 2004SESE
K041065PANALOK RC LOOP ANCHORDepuy MitekMay 7, 2004SESE
K031127ORTHOPEDIC WIREHowmedica Osteonics Corp.Apr 28, 2003SESE
K023388MITEK RAPIDLOC-PDS MENISCAL REPAIR SYSTEMMitek WorldwideDec 27, 2002SESE
K021953MITEK PDS/PGA STAPLEMitek WorldwideDec 20, 2002SESE
K023417SURETAC III, MODELS 7209900, 7209901Smith & Nephew, Inc.Nov 7, 2002SESE
K023203OSSTAPLEBiomedical Ent., Inc.Oct 17, 2002SESE
K020948SMITH & NEPHEW SURETAC - EXPANDED INDICATIONS IISmith & Nephew, Inc.Oct 9, 2002SESE
K012081DYNAMIC COMPRESSION SHAPE MEMORY ALLOY (SMA) STAPLE SYSTEMMedtronic Sofamor Danek, Inc.Oct 1, 2001SESE
K011716THE UNI-CLIP STAPLENew Deal, S.A.Aug 30, 2001SESE
K010051POLY-TAPES WITH THE FASTLOK FIXATION DEVICEXiros PlcJul 13, 2001SESE
K002695MEMODYN STAPLETelos Medical EquipmentJun 13, 2001SESE
K003033SCAPHIX, STAPLE, FIXATION, BONEAvanta Orthopaedics, Inc.May 30, 2001SESE
K001354MEMOGRAPH; OSSTAPLE - ORTHOPEDIC USES FOR SMALL BONE AND FRAGMENT FIXATION FOR THE MEMOGRAPH STAPLE SYSTEMBiomedical Ent., Inc.Mar 13, 2001SESE
K000797OBL 2.0 MM MINI TAC ANCHOR, MODEL 10-1629-01Orthopaedic Biosystems, Ltd.Apr 3, 2000SESE
K993714MEMOGRAPH STAPLE, WARM SYSTEMBiomedical Ent., Inc.Feb 25, 2000SESE
K991962EIS DYNAMIC MEMORY STAPLES SYSTEMGroupe LepineJan 10, 2000SESE
K991566SOLUSTAPLENew Deal, S.A.Aug 3, 1999SESE
K991482UNI-CLIP STAPLENew Deal, S.A.Jun 3, 1999SESE
K982996POLYMER OBL SB ANCHOR / SUTURE COMBINATIONOrthopaedic Biosystems, Ltd.Mar 4, 1999SESE
K982420MITEK MICRO ANCHORMitek ProductsAug 24, 1998SESE
K981798LACTOSORB POP RIVETBiomet, Inc.Jul 13, 1998SESE
K964226MEMORY STAPLE (20 SIZES AVAILABLE)Landos, Inc.Aug 5, 1997SESE
K965175HOWMEDICA MAINSTAY ANCHORHowmedica Corp.Mar 13, 1997SESE
K962793MITEK MICRO ANCHORMitek ProductsOct 1, 1996SESE
K962705MLI MODULAR STAPLEMedicinelodge, Inc.Oct 1, 1996SESE
K961585SURGICAL DYNAMICS POP RIVETUnited States Surgical, A Division of Tyco HealthcJul 10, 1996SESE
K961578SUTURE ANCHORUnited States Surgical, A Division of Tyco HealthcJul 10, 1996SESE
K961555ACUFEX TAG BIOABSORBABLE ANCHORSAcufex Microsurgical, Inc.Jul 10, 1996SESE
K954443LACTOSORB SUTURE ANCHORPoly-Medics,Inc.Jan 31, 1996SN
K950272PANALOK ABSORBABLE SUTURE ANCHOR SYSTEMETHICON, Inc.Jan 18, 1996SN
K953276ACUFEX TAG DELIVERY SYSTEMAcufex Microsurgical, Inc.Oct 5, 1995SESE
K953531HOWMEDICA MAINSTAY ANCHORHowmedica Corp.Sep 26, 1995SN
K953764LMT BONE ANCHORLi Medical Technologies, Inc.Aug 25, 1995SESE
K942889SB ANCHOROrthopaedic Biosystems, Ltd.Aug 25, 1995SESE
K952348OGDEN ANCHORAmerican Medical Electronics, Inc.Aug 21, 1995SESE
K941772CRADLE FIXATION DEVICENeoligaments, Ltd.Aug 7, 1995SESE
K951658LACTOSORB POP RIVETPoly-Medics,Inc.Jul 25, 1995SN
K943950ETHICON NONABSORBABLE SUTURE ANCHORETHICON, Inc.May 30, 1995SN
K950070MITEK TOGGLE ANCHOR(TM)Mitek Surgical Products, Inc.May 22, 1995SESE
K946346ACUFEX TAG(R) BIOABSORBABLE ANCHORSAcufex Microsurgical, Inc.Apr 26, 1995SESE
K944936MITEK G III ANCHOR, MITEK LS ANCHORMitek Surgical Products, Inc.Mar 24, 1995SESE
K943548BIOABSORBABLE INTERFERENCE SCREWAcufex Microsurgical, Inc.Mar 20, 1995SESE
K945203MITEK THRADED ANCHOR (MTA)Mitek Surgical Products, Inc.Mar 6, 1995SESE
K941029OGDEN ANCHOR-SMALL (TENTATIVE)American Medical Electronics, Inc.Feb 9, 1995SESE
K934867ACUFEX TAG ANCHORAcufex Microsurgical, Inc.Feb 9, 1995SESE
K943492ARTHREX STAPLESArthrex, Inc.Feb 1, 1995SN
K935065OGDEN ANCHOR ADDITIONAL APPLICATIONSAmerican Medical Electronics, Inc.Jan 30, 1995SESE
K942787BONE ANCHORAcu Med, Inc.Dec 15, 1994SESE
K935321INNOVASIVE SUTURE BONE FASTENER WITH SUTUREInnovasive Devices, Inc.Oct 19, 1994SESE
K932041XANCHOR SUTURE ATTACHMENT DEVICEOrthopaedic BiosystemsAug 12, 1994SN
K931782MITEK GIII ANCHORMitek Surgical Products, Inc.Jul 22, 1994SN
K935167OGDEN ANCHOR (MODIFICATION)American Medical Electronics, Inc.Jul 12, 1994SN
K931519ACUFEX SURETACAcufex Microsurgical, Inc.Jun 16, 1994SESE
K931253QUICKANCHOR IIMitek Surgical Products, Inc.Jun 16, 1994SESE
K932925BONE ANCHOR FOR SOFT TISSUE ATTACHMENTVesitec Medical, Inc.Apr 26, 1994SESE
K930967BAUMER STAPLESBaumer Ortopedia , Ltd.Mar 7, 1994SESE
K930892MITEK MINI ANCHOR, MODIFICATIONMitek Surgical Products, Inc.Jan 7, 1994SESE
K930893MITEK SUPER QUICKANCHOR, MODIFICATIONMitek Surgical Products, Inc.Dec 8, 1993SESE
K926384STATAK & MINI-STATAK SOFT TISSUE ATTACHMENT DEVICEZimmer, Inc.Nov 16, 1993SESE
K926270MITEK LIGAMENT ANCHORMitek Surgical Products, Inc.Oct 22, 1993SESE
K930538ACUFEX SURETAC(R) PACAcufex Microsurgical, Inc.Sep 13, 1993SESE
K924034MINVASIVE SUTURE BONE FASTENERInnovasive Devices, Inc.Aug 24, 1993SESE
K924367OGDEN ANCHORAdvanced Surgical Implants, Inc.Jul 26, 1993SESE
K911293ACUFEX(R) TAG(TM)Acufex Microsurgical, Inc.Jul 21, 1993SESE
K931182VESITEC DRILL GUIDEVesitec Medical, Inc.Jun 9, 1993SESE
K924941CONCEPT 4MM CANCELLOUS SCREW WITH EYELETLinvatec Corp.Jun 4, 1993SESE
K926037HARPOON SUTURE ANCHORBiomet, Inc.May 5, 1993SESE
K924665QUICKANCHORMitek Surgical Products, Inc.Oct 27, 1992SESE
K915889MITEK BONE ANCHOR, MODIFICATIONMitek Surgical Products, Inc.Oct 22, 1992SESE
K921873QUICKANCHOR, MODIFICATIONMitek Surgical Products, Inc.Jun 9, 1992SESE
K920213MITEK ANCHOR, MITEK ANCHOR IIMitek Surgical Products, Inc.May 1, 1992SESE
K911837SURETAC POLYGLYCONATE ABSORBABLE FIXATION DEVICEAcufex Microsurgical, Inc.Nov 15, 1991SESE
K913461FASTLOK (STAPLE & BUCKLE) FIXATION SYSTEMNeoligaments, Ltd.Oct 15, 1991SESE
K911445FASTLOK (STAPLE AND BUCKLE) FIXATION SYSTEMNeoligaments, Ltd.Jun 28, 1991SESE
K911031THE TRAMOND PINSport Service, Inc.May 29, 1991SESE
K911026STAPLE BLADE FOR TIBIAL OSTEO/STAPLE BLADE L'UNIONSport Service, Inc.May 29, 1991SESE
K911020LIGAMENTOPLASTIC STAPLE OF L'UNIONSport Service, Inc.May 29, 1991SESE
K910723BIODEGRADABLE SURGICAL STAPLEInstrument Makar, Inc.Mar 12, 1991SESE

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