FDA 510(k) Applications for Medical Device Product Code "JDR"
(Staple, Fixation, Bone)

FDA 510(k) Number Applicant Device Name Decision Date
K840566 3M COMPANY BONE STAPLING FIXATION SYS 11/23/1984
K902567 A. HENNISS STAPLE, SERRATED, FIXATION W/SPIKES, VARIOUS SIZES 07/10/1990
K931519 ACUFEX MICROSURGICAL, INC. ACUFEX SURETAC 06/16/1994
K930538 ACUFEX MICROSURGICAL, INC. ACUFEX SURETAC(R) PAC 09/13/1993
K934867 ACUFEX MICROSURGICAL, INC. ACUFEX TAG ANCHOR 02/09/1995
K961555 ACUFEX MICROSURGICAL, INC. ACUFEX TAG BIOABSORBABLE ANCHORS 07/10/1996
K953276 ACUFEX MICROSURGICAL, INC. ACUFEX TAG DELIVERY SYSTEM 10/05/1995
K946346 ACUFEX MICROSURGICAL, INC. ACUFEX TAG(R) BIOABSORBABLE ANCHORS 04/26/1995
K911293 ACUFEX MICROSURGICAL, INC. ACUFEX(R) TAG(TM) 07/21/1993
K943548 ACUFEX MICROSURGICAL, INC. BIOABSORBABLE INTERFERENCE SCREW 03/20/1995
K911837 ACUFEX MICROSURGICAL, INC. SURETAC POLYGLYCONATE ABSORBABLE FIXATION DEVICE 11/15/1991
K942787 ACUMED, INC. BONE ANCHOR 12/15/1994
K924367 ADVANCED SURGICAL IMPLANTS, INC. OGDEN ANCHOR 07/26/1993
K952348 AMERICAN MEDICAL ELECTRONICS, INC. OGDEN ANCHOR 08/21/1995
K935167 AMERICAN MEDICAL ELECTRONICS, INC. OGDEN ANCHOR (MODIFICATION) 07/12/1994
K935065 AMERICAN MEDICAL ELECTRONICS, INC. OGDEN ANCHOR ADDITIONAL APPLICATIONS 01/30/1995
K941029 AMERICAN MEDICAL ELECTRONICS, INC. OGDEN ANCHOR-SMALL (TENTATIVE) 02/09/1995
K172052 Arthrex Inc. Arthrex DynaNite Nitinol Staple 12/13/2017
K080111 ARTHREX, INC. ARTHREX COMPRESSION STAPLE 02/13/2008
K943492 ARTHREX, INC. ARTHREX STAPLES 02/01/1995
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
K930967 BAUMER ORTOPEDIA LTD. BAUMER STAPLES 03/07/1994
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
K861137 BIOMEDICAL EXPORTS, INC. ORTHOMED ORTHOPAEDIC FIXATION STAPLES 04/17/1986
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
K926037 BIOMET, INC. HARPOON SUTURE ANCHOR 05/05/1993
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
K894929 CONCEPT, INC. STAPLE FIXATION SYSTEM 08/30/1989
K071477 CORE ESSENCE ORTHOPAEDICS, LLC REVERTO 55 AND 37 SHAPE MEMORY STAPLES 08/15/2007
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
K943950 ETHICON, INC. ETHICON NONABSORBABLE SUTURE ANCHOR 05/30/1995
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
K991962 GROUPE LEPINE EIS DYNAMIC MEMORY STAPLES SYSTEM 01/10/2000
K822943 HOWMEDICA CORP. ELLISON VITALLIUM FIXATION STAPLE SYS 10/27/1982
K792204 HOWMEDICA CORP. HOWMEDICA COMPRESSION STAPLE SYSTEM 12/05/1979
K965175 HOWMEDICA CORP. HOWMEDICA MAINSTAY ANCHOR 03/13/1997
K953531 HOWMEDICA CORP. HOWMEDICA MAINSTAY ANCHOR 09/26/1995
K895117 HOWMEDICA CORP. HTO COMPRESSING STAPLE 05/09/1990
K031127 HOWMEDICA OSTEONICS CORP. ORTHOPEDIC WIRE 04/28/2003
K153770 IN2BONES SAS OS2(R)-VP Varisation Staple 03/21/2016
K153395 IN2BONES SAS OS2-C Compression Staple 02/18/2016
K143323 IN2Bones SAS OS2-V Varisation Staple 02/26/2015
K161426 IN2BONESUSA, LLC NeoSpan Compression Staple Impant w/instruments 10/24/2016
K935321 INNOVASIVE DEVICES, INC. INNOVASIVE SUTURE BONE FASTENER WITH SUTURE 10/19/1994
K924034 INNOVASIVE DEVICES, INC. MINVASIVE SUTURE BONE FASTENER 08/24/1993
K133523 INSTRATEK, INC. STAPIX SUPERELASTIC IMPLANT BONE STAPLES 02/06/2014
K910723 INSTRUMENT MAKAR, INC. BIODEGRADABLE SURGICAL STAPLE 03/12/1991
K830455 INSTRUMENT MAKAR, INC. STAPLES DESIGNED FOR ARTHROSCOPIC SURG 03/09/1983
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
K893203 KARLIN TECHNOLOGY, INC. BONE SCREW 04/04/1990
K854445 KIRSCHNER MEDICAL CORP. KIRSCHNER BONE FIXATION FASTENER SYSTEM 11/19/1985
K964226 LANDOS, INC. MEMORY STAPLE (20 SIZES AVAILABLE) 08/05/1997
K953764 LI MEDICAL TECHNOLOGIES, INC. LMT BONE ANCHOR 08/25/1995
K873507 LINK AMERICA, INC. LINK (R) AMERICAN-TYPE BONE STAPLE SYSTEM 09/16/1987
K853704 LINK AMERICA, INC. LINK DYNAMIC STAPLE 01/21/1986
K924941 LINVATEC CORP. CONCEPT 4MM CANCELLOUS SCREW WITH EYELET 06/04/1993
K962705 MEDICINE LODGE, INC. MLI MODULAR STAPLE 10/01/1996
K102387 MEDISCOPE MANUFACTURING, INC. MEDISCOPE COMPRESSIOPN STAPLE AND ACCESSORIES 10/24/2011
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
K892126 MITEK SURGICAL PRODUCTS, INC. MITEK ANCHOR 09/19/1989
K902751 MITEK SURGICAL PRODUCTS, INC. MITEK ANCHOR II 07/24/1990
K897155 MITEK SURGICAL PRODUCTS, INC. MITEK ANCHOR(TM) 04/04/1990
K920213 MITEK SURGICAL PRODUCTS, INC. MITEK ANCHOR, MITEK ANCHOR II 05/01/1992
K915889 MITEK SURGICAL PRODUCTS, INC. MITEK BONE ANCHOR, MODIFICATION 10/22/1992
K944936 MITEK SURGICAL PRODUCTS, INC. MITEK G III ANCHOR, MITEK LS ANCHOR 03/24/1995
K931782 MITEK SURGICAL PRODUCTS, INC. MITEK GIII ANCHOR 07/22/1994
K926270 MITEK SURGICAL PRODUCTS, INC. MITEK LIGAMENT ANCHOR 10/22/1993
K930892 MITEK SURGICAL PRODUCTS, INC. MITEK MINI ANCHOR, MODIFICATION 01/07/1994
K930893 MITEK SURGICAL PRODUCTS, INC. MITEK SUPER QUICKANCHOR, MODIFICATION 12/08/1993
K945203 MITEK SURGICAL PRODUCTS, INC. MITEK THRADED ANCHOR (MTA) 03/06/1995
K950070 MITEK SURGICAL PRODUCTS, INC. MITEK TOGGLE ANCHOR(TM) 05/22/1995
K924665 MITEK SURGICAL PRODUCTS, INC. QUICKANCHOR 10/27/1992
K931253 MITEK SURGICAL PRODUCTS, INC. QUICKANCHOR II 06/16/1994
K921873 MITEK SURGICAL PRODUCTS, INC. QUICKANCHOR, MODIFICATION 06/09/1992
K905112 MITEK SURGICAL PRODUCTS, INC. SNAP-PAK (TM) 01/04/1991
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
K941772 NEOLIGAMENTS, LTD. CRADLE FIXATION DEVICE 08/07/1995
K913461 NEOLIGAMENTS, LTD. FASTLOK (STAPLE & BUCKLE) FIXATION SYSTEM 10/15/1991
K911445 NEOLIGAMENTS, LTD. FASTLOK (STAPLE AND BUCKLE) FIXATION SYSTEM 06/28/1991
K904340 NEOLIGAMENTS, LTD. FASTLOK (STAPLE AND BUCKLE) FIXATION SYSTEM 10/19/1990
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
K142111 NOVATSEP ARCAD COMPRESSIVE OSTEOSYNTHESIS STAPLE, EXPRESS COMPRESSIVE OSTEOSYNTHESIS STAPLE 12/19/2014
K905362 O'TEC CORP. BARBED SQUARE STAPLE 12/11/1990
K905363 O'TEC CORP. FIXATION STAPLE 12/11/1990
K905364 O'TEC CORP. ROUND STAPLE 12/11/1990
K903273 ONYX MEDICAL CORP. BARBED SQUARE STAPLE 07/30/1990
K903022 ONYX MEDICAL CORP. FIXATION STAPLE 08/09/1990
K903271 ONYX MEDICAL CORP. ROUND STAPLE 07/30/1990
K890962 ORTHO SPECTRUM, INC. ORTHOPAEDIC STAPLES 05/15/1989
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
K874914 ORTHOMET, INC. ORTHOMET ORTHOPEDIC STAPLES 02/04/1988
K932041 ORTHOPAEDIC BIOSYSTEMS XANCHOR SUTURE ATTACHMENT DEVICE 08/12/1994
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
K942889 ORTHOPAEDIC BIOSYSTEMS, LTD. SB ANCHOR 08/25/1995
K173693 Orthovestments, LLC Orbitum Bone Staple Implant, X and VI 02/23/2018
K811500 OSTEONICS CORP. COLBALT ALLOY ORTHOPAEDIC WIRE 06/18/1981
K141550 OT MEDICAL INSTAFIX SHAPE MEMORY FIXATION SYSTEM 07/11/2014
K170923 Paragon 28 JAWS(TM) Nitinol Staple System 07/24/2017
K951658 POLY-MEDICS,INC. LACTOSORB POP RIVET 07/25/1995
K954443 POLY-MEDICS,INC. LACTOSORB SUTURE ANCHOR 01/31/1996
K853267 PROTEK, INC. DAY STAPLE 09/06/1985
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
K911020 SPORT SERVICE, INC. LIGAMENTOPLASTIC STAPLE OF L'UNION 05/29/1991
K911026 SPORT SERVICE, INC. STAPLE BLADE FOR TIBIAL OSTEO/STAPLE BLADE L'UNION 05/29/1991
K911031 SPORT SERVICE, INC. THE TRAMOND PIN 05/29/1991
K122113 STRYKER CORP. MEMORY METAL STAPLES, EASYCLIP 03/12/2013
K160813 STRYKER GMBH EasyStep 07/26/2016
K102143 SUSPENSION ORTHOPAEDIC SOLUTIONS, LLC SUSPENSION ACROMIOCLAVICULAR (AC) REPAIR SYSTEM 12/08/2010
K904553 SYNTHES (USA) BONE STAPLE(S) 12/21/1990
K180544 Synthes (USA) Products, LLC DePuy Synthes Static Staples 07/24/2018
K813567 TECHMEDICA, INC. TECHMEDIA BONE STAPLE 01/12/1982
K002695 TELOS MEDICAL EQUIPMENT MEMODYN STAPLE 06/13/2001
K896471 TENSTAPLE, INC. TENSTAPLE ORTHOPEDIC STAPLING SYSTEM 07/24/1990
K172405 Trilliant Surgical SNIPER STAPLE SYSTEM, NON-STERILE 12/11/2017
K162354 TRILLIANT SURGICAL LTD Sniper Staple System 04/20/2017
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
K932925 VESITEC MEDICAL, INC. BONE ANCHOR FOR SOFT TISSUE ATTACHMENT 04/26/1994
K931182 VESITEC MEDICAL, INC. VESITEC DRILL GUIDE 06/09/1993
K112837 VILEX, INC. VILEX EZ-STAPLE (MEMORY BONE FIXATION STAPLE) 10/09/2012
K832884 WARSAW ORTHOPEDIC, INC. FIXATION STAPLE DRIVER/EXTRACTOR 10/20/1983
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
K926384 ZIMMER, INC. STATAK & MINI-STATAK SOFT TISSUE ATTACHMENT DEVICE 11/16/1993


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