FDA 510(k) Applications for Medical Device Product Code "JDR"
(Staple, Fixation, Bone)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K961555 | ACUFEX MICROSURGICAL, INC. | ACUFEX TAG BIOABSORBABLE ANCHORS | 07/10/1996 |
| K172052 | Arthrex Inc. | Arthrex DynaNite Nitinol Staple | 12/13/2017 |
| K203180 | Arthrex Inc. | Arthrex DynaNite Nitinol Staples | 12/16/2020 |
| K080111 | ARTHREX, INC. | ARTHREX COMPRESSION STAPLE | 02/13/2008 |
| K061801 | ARTHROTEK, INC. | 2.8 & 3.5MM LACTOSCREW SUTURE ANCHORS | 08/07/2006 |
| K061389 | ARTHROTEK, INC. | ALLTHREAD LACTOSORB SUTURE ANCHOR | 07/19/2006 |
| K061776 | ARTHROTEK, INC. | ARTHROTEK MAXFIRE MENISCAL REPAIR DEVICE | 09/25/2006 |
| K061657 | ARTHROTEK, INC. | HITCH LACTOSORB SUTURE ANCHOR | 07/25/2006 |
| K161587 | AUSTIN & ASSOCIATES, INC./TELOS MEDICAL EQUIPMENT | Memodyn Staple | 02/01/2017 |
| K003033 | AVANTA ORTHOPAEDICS, INC. | SCAPHIX, STAPLE, FIXATION, BONE | 05/30/2001 |
| K060970 | AXYA MEDICAL, INC. | AXYALOOP NONABSORBABLE BONE ANCHOR | 07/05/2006 |
| K993714 | BIOMEDICAL ENT., INC. | MEMOGRAPH STAPLE, WARM SYSTEM | 02/25/2000 |
| K001354 | BIOMEDICAL ENT., INC. | MEMOGRAPH; OSSTAPLE - ORTHOPEDIC USES FOR SMALL BONE AND FRAGMENT FIXATION FOR THE MEMOGRAPH STAPLE SYSTEM | 03/13/2001 |
| K023203 | BIOMEDICAL ENT., INC. | OSSTAPLE | 10/17/2002 |
| K102107 | BIOMEDICAL ENT., INC. | OSSTAPLE CHILL | 09/03/2010 |
| K133844 | BIOMEDICAL ENT., INC. | SPEED TRIAD | 04/07/2014 |
| K133780 | BIOMEDICAL ENT., INC. | SPEED XL | 03/19/2014 |
| K133270 | BIOMEDICAL ENTERPRISES, INC | SPEED ARC | 04/17/2014 |
| K124022 | BIOMEDICAL ENTERPRISES, INC | SPEED SHIFT | 05/14/2013 |
| K150125 | BioMedical Enterprises, Inc. | Elite Nitinol Fixation System | 05/11/2015 |
| K142292 | BioMedical Enterprises, Inc. | Speed, Speed Shift, Speed Titan, Speed Arc | 11/17/2014 |
| K081172 | BIOMET MANUFACTURING CORP. | COMPOSITE HITCH SUTURE ANCHOR | 07/17/2008 |
| K143037 | BIOMET MANUFACTURING CORP. | SnapShot Fixation System | 01/20/2015 |
| K151615 | BIOMET MANUFACTURING CORP. | TiTHON Staple with OsseoTi Technology | 10/02/2015 |
| K141263 | BIOMET MANUFACTURING CORP. | TOGGLELOC AND JUGGERLOC IMPLANTS/INSTRUMENTS/KITS | 11/19/2014 |
| K041988 | BIOMET, INC. | ARTHROTEK MENISCAL HYBRID DEVICE | 10/20/2004 |
| K981798 | BIOMET, INC. | LACTOSORB POP RIVET | 07/13/1998 |
| K061798 | BIOPRO, INC. | BIOPRO MEMORY STAPLE | 08/21/2006 |
| K072298 | BIOPRO, INC. | BIOPRO MEMORY STAPLE, MODELS 18062-18073 | 10/29/2007 |
| K071477 | CORE ESSENCE ORTHOPAEDICS, LLC | REVERTO 55 AND 37 SHAPE MEMORY STAPLES | 08/15/2007 |
| K190722 | CrossRoads Extemity Systems, LLC | TriMAX Implant System | 08/16/2019 |
| K181410 | CrossRoads Extremity Systems, LLC | MotoCLIP/HiMAX Implant System | 06/29/2018 |
| K181866 | CrossRoads Extremity Systems, LLC | MotoCLIP/HiMAX Step Staple Implant System | 08/09/2018 |
| K122871 | DALLEN MEDICAL, INC. | COMPRESSYN STAPLE | 02/07/2013 |
| K132875 | DALLEN MEDICAL, INC. | COMPRESSYN STAPLE | 12/30/2013 |
| K140358 | DALLEN MEDICAL, INC. | COMPRESSYN STAPLE | 06/02/2014 |
| K171473 | Dallen Medical, Inc. | CompressynÖ Staple | 11/07/2017 |
| K063273 | DEPUY MILTEK, A JOHNSON & JOHNSON CO. | PANALOK QUICKANCHOR PLUS, PANALOK RC QUICKANCHOR PLUS DUAL SUTURE, PANALOK ANCHOR | 11/22/2006 |
| K041064 | Depuy Mitek | BIOKNOTLESS RC ANCHOR | 05/13/2004 |
| K041065 | Depuy Mitek | PANALOK RC LOOP ANCHOR | 05/07/2004 |
| K041117 | Depuy Mitek | PANALOK RC QUICKANCHOR PLUS, MODEL 212130, 212730; DUAL SUTURE PANALOK RC QUICKANCHOR PLLUS, MODELS 212132, 212732 | 05/28/2004 |
| K041116 | Depuy Mitek | SUPER QUICKANCHOR PLUS | 05/28/2004 |
| K062170 | DEPUY MITEK, A JOHNSON & JOHNSON COMPANY | BIOKNOTLESS AND LUPINE PLUS ANCHORS | 08/22/2006 |
| K073281 | DEPUY MITEK, A JOHNSON & JOHNSON COMPANY | CAIS STAPLE | 05/02/2008 |
| K041115 | DEPUY MITEK, A JOHNSON & JOHNSON COMPANY | GII QUICKANCHOR PLUS | 05/28/2004 |
| K051989 | DEPUY MITEK, A JOHNSON & JOHNSON COMPANY | GII QUICKANCHOR PLUS WITH ORTHOCORD SUTURE | 08/05/2005 |
| K071257 | DEPUY MITEK, A JOHNSON & JOHNSON COMPANY | MINI QUICKANCHOR AND QUICKANCHOR PLUS WITH ORTHOCORD | 06/29/2007 |
| K060553 | DEPUY MITEK, A JOHNSON & JOHNSON COMPANY | RC LOOP /DUAL ORTHOCORD SUTURE,RC LOOP W/ETHIBOND SUTURE,RC LOOP W/PANACRYL SUTURE | 05/04/2006 |
| K052631 | DEPUY MITEK, A JOHNSON & JOHNSON COMPANY | SUPER QUICKANCHOR PLUS (WITH ORTHOCORD SUTURE) | 10/21/2005 |
| K060746 | DEPUY ORTHOPAEDICS, INC. | MEMORY STAPLE | 05/25/2006 |
| K163226 | Epic Extremely, LLC | EPIC Extremely Small Staple | 05/16/2017 |
| K950272 | ETHICON, INC. | PANALOK ABSORBABLE SUTURE ANCHOR SYSTEM | 01/18/1996 |
| K172205 | ExoToe LLC | ExoToe Staple | 01/11/2018 |
| K173775 | F & A Foundation LLC d.b.a. Reign Medical | Clench Compression Staple | 04/06/2018 |
| K153622 | FIRST RAY LLC | First Ray Internal Bone Staple System | 04/08/2016 |
| K163440 | FIRST RAY LLC | Stealth Staple System | 02/01/2017 |
| K181815 | Fusion Orthopedics, LLC | DynaBridge | 10/15/2018 |
| K182212 | Gramercy Extremity Orthopedics, LLC | Geo Staple System | 01/11/2019 |
| K991962 | GROUPE LEPINE | EIS DYNAMIC MEMORY STAPLES SYSTEM | 01/10/2000 |
| K965175 | HOWMEDICA CORP. | HOWMEDICA MAINSTAY ANCHOR | 03/13/1997 |
| K031127 | HOWMEDICA OSTEONICS CORP. | ORTHOPEDIC WIRE | 04/28/2003 |
| K153395 | IN2BONES SAS | OS2-C Compression Staple | 02/18/2016 |
| K143323 | IN2Bones SAS | OS2-V Varisation Staple | 02/26/2015 |
| K153770 | IN2BONES SAS | OS2(R)-VP Varisation Staple | 03/21/2016 |
| K161426 | IN2BONESUSA, LLC | NeoSpan Compression Staple Impant w/instruments | 10/24/2016 |
| K133523 | INSTRATEK, INC. | STAPIX SUPERELASTIC IMPLANT BONE STAPLES | 02/06/2014 |
| K051408 | INTELIFUSE, INC. | INTELIFUSE, INC. WARM SYSTEM WITH STIMULINKS | 06/29/2005 |
| K060014 | INTELIFUSE, INC. | INTELIFUSE, INC., WARMSYSTEM WITH STIMULINKS | 04/03/2006 |
| K071637 | INTRINSIC THERAPEUTICS INCORPORATED | INTRINSIC THERAPEUTICS FIXATION STAPLE | 08/03/2007 |
| K964226 | LANDOS, INC. | MEMORY STAPLE (20 SIZES AVAILABLE) | 08/05/1997 |
| K210456 | Medacta International SA | Ligament Staple | 04/12/2021 |
| K191636 | Medartis AG | APTUS Foot System | 08/16/2019 |
| K232324 | Medartis Inc. | StealthFix Intraosseous Fixation System | 08/30/2023 |
| K962705 | MEDICINE LODGE, INC. | MLI MODULAR STAPLE | 10/01/1996 |
| K102387 | MEDISCOPE MANUFACTURING, INC. | MEDISCOPE COMPRESSIOPN STAPLE AND ACCESSORIES | 10/24/2011 |
| K210482 | Medline Industries, Inc. | Medline UNITE REFLEX Nitinol Staple System | 04/22/2021 |
| K231885 | Medline Industries, LP | Medline UNITE« REFLEX« Nitinol Staple System | 08/09/2023 |
| K193305 | MedShape, Inc. | DynaClip Bone Staple | 04/23/2020 |
| K220812 | MedShape, Inc. | DynaClip« Bone Staple | 08/19/2022 |
| K181781 | MedShape, Inc. | DynaClipTM Bone Staple | 11/05/2018 |
| K012081 | MEDTRONIC SOFAMOR DANEK, INC. | DYNAMIC COMPRESSION SHAPE MEMORY ALLOY (SMA) STAPLE SYSTEM | 10/01/2001 |
| K070031 | MEMOMETAL TECHNOLOGIES | MEMOMETAL MEMORY STAPLES | 03/19/2007 |
| K070033 | MEMOMETAL TECHNOLOGIES | MEMOMETAL VARISATION, MODELS AV26-08, AV26-10, AV90-08 AND AV90-10 | 03/19/2007 |
| K151762 | MERETE MEDICAL GMBH | PediatrOS RigidTack/FlexTack | 12/28/2015 |
| K123926 | METASURG | METASURG NITINOL STAPLE IMPLANT | 05/03/2013 |
| K123363 | METRIC MEDICAL DEVICES, INC. | SUPER STAPLE(TM) CLASSIC | 01/03/2013 |
| K962793 | MITEK PRODUCTS | MITEK MICRO ANCHOR | 10/01/1996 |
| K982420 | MITEK PRODUCTS | MITEK MICRO ANCHOR | 08/24/1998 |
| K021953 | MITEK WORLDWIDE | MITEK PDS/PGA STAPLE | 12/20/2002 |
| K023388 | MITEK WORLDWIDE | MITEK RAPIDLOC-PDS MENISCAL REPAIR SYSTEM | 12/27/2002 |
| K143622 | MX Orthopedics, Corp. | dynaMX Compression Staple | 06/17/2015 |
| K153129 | MX Orthopedics, Corp. | dynaMX Tabbed Staple | 01/28/2016 |
| K192447 | Neosteo | Superelastic Staple | 02/28/2020 |
| K061594 | NEWDEAL S.A. | LARGE UNI-CLIP STAPLE | 07/03/2006 |
| K991566 | NEWDEAL S.A. | SOLUSTAPLE | 08/03/1999 |
| K011716 | NEWDEAL S.A. | THE UNI-CLIP STAPLE | 08/30/2001 |
| K991482 | NEWDEAL S.A. | UNI-CLIP STAPLE | 06/03/1999 |
| K070688 | NEXA ORTHOPEDICS, INC. | NEXFIX COMPRESSION STAPLE | 05/18/2007 |
| K131061 | NEXTREMITY SOLUTIONS | RESTORE BUNION CORRECTION SYSTEM | 08/28/2013 |
| K151160 | NEXTREMITY SOLUTIONS, INC. | Arcus Staple System | 09/04/2015 |
| K220181 | Nextremity Solutions, Inc. | StealthFix Intraosseous Fixation System | 03/22/2022 |
| K142111 | NOVATSEP | ARCAD COMPRESSIVE OSTEOSYNTHESIS STAPLE, EXPRESS COMPRESSIVE OSTEOSYNTHESIS STAPLE | 12/19/2014 |
| K182943 | Nvision Biomedical Technologies, LLC | VERTEX Nitinol Staple System | 04/04/2019 |
| K142727 | OrthoDiscovery Group LLC(D.B.A. CrossRoads Extremity Systems | CrossCLIP Implant System | 10/24/2014 |
| K142148 | ORTHOHELIX SURGICAL DESIGNS, INC. | ORTHOHELIX STAPLE SYSTEM | 08/21/2014 |
| K130832 | ORTHOHELIX SURGICAL DESIGNS, INC. | ORTHOHELIX STAPLE SYSTEM | 08/15/2013 |
| K000797 | ORTHOPAEDIC BIOSYSTEMS, LTD. | OBL 2.0 MM MINI TAC ANCHOR, MODEL 10-1629-01 | 04/03/2000 |
| K982996 | ORTHOPAEDIC BIOSYSTEMS, LTD. | POLYMER OBL SB ANCHOR / SUTURE COMBINATION | 03/04/1999 |
| K173693 | Orthovestments, LLC | Orbitum Bone Staple Implant, X and VI | 02/23/2018 |
| K141550 | OT MEDICAL | INSTAFIX SHAPE MEMORY FIXATION SYSTEM | 07/11/2014 |
| K170923 | Paragon 28 | JAWS(TM) Nitinol Staple System | 07/24/2017 |
| K230550 | Paragon 28 Inc | JAWS Nitinol Staple System | 05/11/2023 |
| K223056 | Paragon 28, Inc. | JAWS Nitinol Staple System | 02/16/2023 |
| K954443 | POLY-MEDICS,INC. | LACTOSORB SUTURE ANCHOR | 01/31/1996 |
| K231458 | restor3d | Extremity Staple | 08/03/2023 |
| K162321 | RESTORE SURGICAL LLC dba Instratek | EasyClip Xpress | 02/10/2017 |
| K071479 | SMALL BONE INNOVATIONS INC. | SBI STAFIX | 08/02/2007 |
| K081098 | SMITH & NEPHEW INC., ENDOSCOPY DIVISION | ENDOBUTTON CONTINUOUS LOOP (CL) | 07/16/2008 |
| K082215 | SMITH & NEPHEW INC., ENDOSCOPY DIVISION | OSTEORAPTOR SUTURE ANCHOR | 11/03/2008 |
| K020948 | SMITH & NEPHEW, INC. | SMITH & NEPHEW SURETAC - EXPANDED INDICATIONS II | 10/09/2002 |
| K023417 | SMITH & NEPHEW, INC. | SURETAC III, MODELS 7209900, 7209901 | 11/07/2002 |
| K124045 | SOLANA SURGICAL, LLC | FUSEFORCE IMPLANT SYSTEM | 07/10/2013 |
| K122113 | STRYKER CORP. | MEMORY METAL STAPLES, EASYCLIP | 03/12/2013 |
| K210582 | Stryker GmbH | EasyClip« and EasyClip« Xpress | 06/10/2022 |
| K160813 | STRYKER GMBH | EasyStep | 07/26/2016 |
| K102143 | SUSPENSION ORTHOPAEDIC SOLUTIONS, LLC | SUSPENSION ACROMIOCLAVICULAR (AC) REPAIR SYSTEM | 12/08/2010 |
| K191463 | Synthes (USA) Products, LLC | DePuy Synthes Hammertoe Continuous Compression Implant | 02/26/2020 |
| K180544 | Synthes (USA) Products, LLC | DePuy Synthes Static Staples | 07/24/2018 |
| K002695 | TELOS MEDICAL EQUIPMENT | MEMODYN STAPLE | 06/13/2001 |
| K232387 | Treace Medical Concepts | Treace Medical Concepts (TMC) Compression Implant System | 08/28/2023 |
| K222645 | Treace Medical Concepts | Treace Medical Concepts (TMC) Implant Fixation System | 11/21/2022 |
| K172405 | Trilliant Surgical | SNIPER STAPLE SYSTEM, NON-STERILE | 12/11/2017 |
| K162354 | TRILLIANT SURGICAL LTD | Sniper Staple System | 04/20/2017 |
| K190166 | TriMed, Inc. | TriMed Nitinol Staple System | 07/01/2019 |
| K221947 | Tyber Medical, LLC. | Tyber Medical Staple Fixation System (various) | 10/20/2022 |
| K961585 | UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC | SURGICAL DYNAMICS POP RIVET | 07/10/1996 |
| K961578 | UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC | SUTURE ANCHOR | 07/10/1996 |
| K062734 | VALPO ORTHOPEDIC TECHNOLOGY, INC. | ADJUST-RIGHT FIXATION DEVICES | 11/22/2006 |
| K112837 | VILEX, INC. | VILEX EZ-STAPLE (MEMORY BONE FIXATION STAPLE) | 10/09/2012 |
| K231493 | Vilex, LLC | NITINEX Memory Compression Staple | 08/11/2023 |
| K203832 | Wright Medical | FuseForceÖ Flex Dynamic Compression System | 05/07/2021 |
| K043059 | WRIGHT MEDICAL TECHNOLOGY, INC. | COMPRESSION STAPLE AND SIMPLE STAPLE | 01/18/2005 |
| K010051 | XIROS PLC | POLY-TAPES WITH THE FASTLOK FIXATION DEVICE | 07/13/2001 |
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