FDA 510(k) Applications for Medical Device Product Code "MAI"
(Fastener, Fixation, Biodegradable, Soft Tissue)

FDA 510(k) Number Applicant Device Name Decision Date
K933948 ACUFEX MICROSURGICAL, INC. ACUFEX ENDOBUTTON SYSTEM 07/21/1994
K070178 AESCULAP IMPLANT SYSTEM, INC. AESCULAP RESORBABLE PIN, MODEL FR735 04/30/2007
K171299 AJU Pharm Co.,Ltd. Fixone Biocomposite Anchor 08/24/2017
K173788 Arthrex Inc. Arthrex Corkscrew FT 03/01/2018
K180662 Arthrex Inc. Arthrex FastThread Interference Screw 05/22/2018
K173240 Arthrex Inc. Arthrex PushLock 01/16/2018
K180768 Arthrex Inc. Arthrex SwiveLock Anchors 12/14/2018
K171141 Arthrex Inc. Arthrex SwiveLock Anchors 05/04/2017
K082810 ARTHREX, INC. ARTHREX BIO-COMPOSITE SUTURE ANCHORS: ARTHREX BIO-COMPOSITE PUSHLOCK, BIO-COMPOSITE TAK AND BIO-COMPOSITE CORKSCREW 01/23/2009
K091844 ARTHREX, INC. ARTHREX BIO-COMPOSITE SUTURETAK ANCHORS 08/28/2009
K011495 ARTHREX, INC. ARTHREX BIO-POST AND WASHER 08/01/2001
K110660 ARTHREX, INC. ARTHREX BIOCOMPOSITE SUTURETAK 03/31/2011
K112040 ARTHREX, INC. ARTHREX BIOCOMPOSITE TRANSFIX 12/15/2011
K062466 ARTHREX, INC. ARTHREX INTERFERENCE SCREW 11/29/2006
K983577 ARTHREX, INC. ARTHREX MENISCAL DART SYSTEM 08/13/1999
K082999 ARTHREX, INC. ARTHREX MENISCAL DART, ARTHREX MENISCAL DARTSTICK, ARTHREX CHONDRAL DART 12/30/2008
K990340 ARTHREX, INC. ARTHREX PLA TISSUETAK, MODEL # AR-1940 BU 01/28/2000
K071456 ARTHREX, INC. ARTHREX PROSTOP PLUS ARTHROEREISIS SUBTALAR IMPLANT 01/17/2008
K101679 ARTHREX, INC. ARTHREX PUSHLOCK ANCHORS 10/22/2010
K140855 ARTHREX, INC. ARTHREX SUTURETAK SUTURE ANCHORS 12/18/2014
K101823 ARTHREX, INC. ARTHREX SWIVELOCK ANCHORS 01/07/2011
K151342 ARTHREX, INC. Arthrex SwiveLock Anchors 03/24/2016
K003227 ARTHREX, INC. BIO-ABSORBABLE CORKSCREW MODEL AR-1920B 01/08/2001
K990987 ARTHREX, INC. BIO-ABSORBABLE CORKSCREW, MODEL AR-1920B 01/13/2000
K983843 ARTHREX, INC. BIO-BUTTON 6.5MM, BIO-BUTTON 8MM, MODEL #'S AR-2236B & AR-2238B 03/12/1999
K000506 ARTHREX, INC. BIO-FASTAK SUTURE ANCHOR, MODEL AR-1324B 05/01/2000
K971358 ARTHREX, INC. BIO-INTERFERENCE SCREW, 7 MM, 8 MM, 9 MM 07/09/1997
K120540 ARTHREX, INC. BIOBOLT 03/20/2012
K990361 ARTHREX, INC. HEADED BIO-ABSORBABLE CORKSCREW MODEL #AR-1921BU 04/14/1999
K180594 Arthrex, Inc. Knotless SutureTak Anchors 06/22/2018
K071176 ARTHREX, INC. MODIFICATION TO: ARTHREX INTERFERENCE SCREW 08/03/2007
K051219 ARTHREX, INC. PUSHLOCK 06/29/2005
K041698 AXYA MEDICAL, INC. AXYA MEDICAL, INC. MODEL 5000 AXYALOOP BIO-ABSORBABLE BONE ANCHOR 10/05/2004
K051250 AXYA MEDICAL, INC. AXYA, MODEL 6500 AXYALOOP BIO-ABSORBABLE BONE ANCHOR 06/09/2005
K051983 AXYA MEDICAL, INC. MODEL 3000 AXYALOOP BIO-ABSORBABLE BONE ANCHOR 08/05/2005
K053492 BIODUCT, LLC BIODUCT 04/12/2007
K002020 BIOMET MANUFACTURING, INC. LACTOSORB MENISCAL SCREW 08/25/2000
K982095 BIOMET, INC. LACTOSORB MENISCAL REPAIR DEVICE 01/27/1999
K003273 BIOMET, INC. LACTOSORB SCREW ANCHOR 01/11/2001
K991009 BIOMET, INC. RC BUTTRESS 06/23/1999
K001378 BIONX IMPLANTS, INC. BIOCUFF, MODELS 225718, 225728, 225736, 235718, 235728, 235736 07/28/2000
K013057 BIONX IMPLANTS, INC. BIOCUFF,C, MODELS 236018, 236028, 236036 10/12/2001
K972783 BIONX IMPLANTS, INC. BIOFIX BIODEGRADABLE THREADED SUTURE ANCHOR 04/14/1998
K974876 BIONX IMPLANTS, INC. BIONX DISTAL RADIUS SCREW 03/20/1998
K003970 BIONX IMPLANTS, INC. CONTOUR LABRAL NAIL, MODEL 533520A 01/12/2001
K012334 BIONX IMPLANTS, INC. CONTOUR MENISCUS ARROW, MODELS 541110, 541113, AND 541116 09/19/2001
K992567 BIONX IMPLANTS, LTD. ANATOMICAL BANKART TACK, MODEL 523520A 08/27/1999
K993453 BIONX IMPLANTS, LTD. MENISCUS ARROW, MODELS 531110, 531113, 531116 11/09/1999
K993074 BIONX IMPLANTS, LTD. SMART NAIL MODELS 521516, 521520,521525, 531516, 531520. 531525 12/10/1999
K993073 BIONX IMPLANTS, LTD. SMART SCREW ACL MODELS 237020, 237025, 237030, 238020, 238025, 238030, 239020, 239025, 239030 12/06/1999
K000616 BIONX IMPLANTS, LTD. SMARTWEDGE ACL, MODELS 430623, 430628, 430723, 430728, 430823, 430828 03/23/2000
K130716 BIORETEC LTD BIORETEC ACTIVASCREW INTERFERENCE 08/28/2013
K952471 BIOSCIENCE, INC. BIOFIX BIOABSORABABLE SELF-REINFORCED POLY-L-LACTIDE, THREADED FIXATION ROD 08/07/1995
K955768 BIOSCIENCE, INC. BIOFIX BIODEGRADABLE MENISCUS ARROW SYSTEM 03/04/1996
K955003 BIOSCIENCE, INC. BIOFIX BIODEGRADABLE SELF-REINFORCED POLY-L-LACTIDE (SR-PLLA) MINI-TACK 01/31/1996
K052799 BONUTTI RESEARCH, INC. MULTITAK 6.0 MM ABSORBABLE ANCHOR SYSTEM 12/16/2005
K012465 BONUTTI RESEARCH, INC. MULTITAK SPLINTER 3.0 MM RESORBABLE ANCHOR 10/29/2001
K993115 BONUTTI RESEARCH, INC. MULTITAK SS 12/17/1999
K170501 ConMed Corporation CrossFT Knotless Biocomposite Suture Anchor with Disposable Driver 03/17/2017
K171592 ConMed Corporation CrossFTÖ Knotless Biocomposite Suture Anchor with Disposable Driver 08/29/2017
K180763 CONMED Corporation CuffLink Implant System Biocomposite 07/19/2018
K092898 CONMED LINVATEC CONMED LINVATEC PRESTO PRELOADED WITH ONE OR TWO #2 HI-FI SUTURES 10/19/2009
K101100 CONMED LINVATEC CROSSFT OC SUTURE ANCHOR MODE CFC-4502, CFC-5502, CFC-6502, CFC-4503, CFC-5503, CFC-6503 08/26/2010
K120078 DEPUY MITEK INC., JOHNSON AND JOHNSON COMPANY HEALIX ADVANCE BR ANCHOR 02/29/2012
K133794 DEPUY MITEK, A JOHNSON & JOHNSON COMPANY 4.5MM HEALIX ADVANCE BR ANCHOR, WITH 2 OR 3 STRANDS OF #2 PERMACORD SUTURE, 5.5MM HEALIX ADVANCE BR ANCHOR, WITH 2 OR 3 02/04/2014
K103831 DEPUY MITEK, A JOHNSON & JOHNSON COMPANY DEPUY MITEK MILAGRO INTERFERENCE SCREW MODEL 231803, 231804, 231807, 231809 07/21/2011
K132241 DEPUY MITEK, A JOHNSON & JOHNSON COMPANY GRYPHON BR ANCHOR W/ PROKNOT TECHNOLOGY, GRYPHON BR ANCHOR W/ PROKNOT TECHNOLOGY - HIP, GRYPHON PEEK ANCHOR W/ PROKNOT T 11/05/2013
K141259 DEPUY MITEK, A JOHNSON & JOHNSON COMPANY GRYPHON BR ANCHOR WITH PERMACORD, GRYPHON BR DS ANCHOR WITH PERMACORD,GRYPHON PEEK ANCHOR WITH PERMACORD, GRYPHON PEEK 06/10/2014
K073412 DEPUY MITEK, A JOHNSON & JOHNSON COMPANY GRYPHON BR AND HEALIX BR ANCHORS 01/17/2008
K090124 DEPUY MITEK, A JOHNSON & JOHNSON COMPANY GRYPHON P BR DS ANCHOR W/ORTHOCORD,GRYPHON P BR ANCHOR W/ORTHOCORD, MODEL 210813,210814 03/11/2009
K100012 DEPUY MITEK, A JOHNSON & JOHNSON COMPANY GRYPHON T BR DS ANCHOR W/ORTHOCORD, GRYPHON T BR ANCHOR W /ORTHOCORD, GRYPHON P BR DS ANCHOR W/ORTHOCORD, GRYPHON P BR A 04/30/2010
K130917 DEPUY MITEK, A JOHNSON & JOHNSON COMPANY HEALIX ADVANCE KNOTLESS BR ANCHOR 05/24/2013
K131974 DEPUY MITEK, A JOHNSON & JOHNSON COMPANY HEALIX ADVANCE KNOTLESS BR ANCHOR (6.5MM) 07/25/2013
K113534 DEPUY MITEK, A JOHNSON & JOHNSON COMPANY HEALIX KNOTLESS ANCHOR 12/20/2011
K112249 DEPUY MITEK, A JOHNSON & JOHNSON COMPANY HEALIX KNOTLESS(TM) ANCHOR 10/25/2011
K143660 DEPUY MITEK, A JOHNSON & JOHNSON COMPANY Milagro / Milagro Advance Interference Screw 05/21/2015
K122869 DEPUY MITEK, A JOHNSON & JOHNSON COMPANY MILAGRO INTERFERENCE SCREWS 12/13/2012
K120589 DEPUY MITEK, A JOHNSON & JOHNSON COMPANY MILAGRO INTERFERENCE SCREWS 04/24/2012
K070925 DEPUY MITEK, A JOHNSON & JOHNSON COMPANY MODIFICATION TO: BIOKNOTLESS BR ANCHOR / LUPINE BR ANCHOR 05/02/2007
K040827 DEPUY MITEK, A JOHNSON & JOHNSON COMPANY PANALOK LOOP ANCHOR 04/30/2004
K091041 DEPUY MITEK, A JOHNSON & JOHNSON COMPANY RIGIDFIX BIOCRYL 2.7MM BTB (210815), FEMORAL 3.3MM ST (210816), AND TIBIAL 3.3MM ST (210817) CROSS PIN KITS 08/07/2009
K090669 DEPUY MITEK, A JOHNSON & JOHNSON COMPANY RIGIDFIX BIOCRYL CROSS PIN KITS 04/03/2009
K140643 DEPUY MITEK, A JOHNSON AND JOHNSON COMPANY GRYPHON BR ANCHOR W/PROKNOT TECHNOLOGY,GRYPHON PEEK ANCHOR W/ PROKNOT TECHNOLOGY 07/08/2014
K150209 Depuy Mitek, a Johnson and Johnson Company Healix BR Anchor, Healix PEEK Anchor, Healix Transtend, Gryphon T and P BR Anchor, Gryphon PEEK Anchor, VersaLok Anchor, Bioknotless BR Anchor, Lupine BR Anchor, PanaLok Anchor,PanaLok Anchor with Orthocord, PanaLok RC QuickAnchor Plus; PanaLok RC QuickAn 10/06/2015
K964521 DEPUY, INC. DEPUY DUPONT PHANTOM SUTURE ANCHOR 02/06/1997
K982900 DEPUY, INC. PHANTOM SOFTHREAD SOFT TISSUE INTERFERENCE SCREW 08/31/1998
K990999 ELECTRO-BIOLOGY, INC. MODIFICATION OF: EBI SPINELINK SYSTEM 04/14/1999
K970896 ETHICON, INC. MITEK 3.5 MM PANALOK WEDGE ABSORBABLE SUTURE ANCHOR SYSTEM 06/09/1997
K952687 ETHICON, INC. PANALOK WEDGE ABSORABLE SUTURE ANCHOR SYSTEM 02/06/1996
K973849 HOGAN & HARTSON BIOABSORBABLE BANKART TACK 01/06/1998
K051362 INION OY INION ANCHRON BIODEGRADABLE ANCHOR SYSTEM, MODEL ANC-6000 08/04/2005
K062782 INION OY INION ANCHRON PLUS BIODEGRADABLE ANCHOR SYSTEM, MODEL ANC-6001 11/09/2006
K973381 INNOVASIVE DEVICES, INC. BIOROC EZ SUTURE BONE FASTENER 02/18/1998
K981340 INNOVASIVE DEVICES, INC. INNOVASIVE DEVICES MENISCAL DART REPAIR SYSTEM 06/22/1998
K984490 INNOVASIVE DEVICES, INC. SUTURELESS ANCHOR 03/01/1999
K994269 INNOVASIVE DEVICES, INC. TITAN RC TACK 01/10/2000
K943249 INSTRUMENT MAKAR, INC. BIOABSORBABLE INTERFERENCE SCREW 07/31/1995
K960555 INSTRUMENT MAKAR, INC. BIOASBSORBABLE MINI-SCREW SUTURE ANCHOR 07/09/1996
K963396 INSTRUMENT MAKAR, INC. BIOSPHERE SUTURE ANCHOR 05/06/1997
K944544 JOHNSON & JOHNSON PROFESSIONALS, INC. ABSORBABLE BONE SCREW 01/26/1996
K983435 LI MEDICAL TECHNOLOGIES, INC. ROTORBLADE 04/29/1999
K992938 LI MEDICAL TECHNOLOGIES, INC. ROTORBLADE SUTURE ANCHOR 09/23/1999
K993373 LI MEDICAL TECHNOLOGIES, INC. ROTORBLADE SUTURE ANCHOR 10/27/1999
K002413 LI MEDICAL TECHNOLOGIES, INC. ULTRASORB SUTURE ANCHOR 09/19/2000
K031981 LINVATEC BIOMATERIALS, LTD. 2.4 SMARTNAIL, MODELS 532416, 532425, 532435, 532445 07/25/2003
K042966 LINVATEC BIOMATERIALS, LTD. DUET SUTURE ANCHOR, MODELS BXS4216, BXS4216H; IMPACT SUTURE ANCHOR, MODELS BXS4218, BXS4218H 11/19/2004
K955486 LINVATEC CORP. BIO-ANCHOR 02/29/1996
K963369 LINVATEC CORP. BIO-ANCHOR 05/22/1997
K964805 LINVATEC CORP. BIO-ANCHOR 06/09/1997
K983186 LINVATEC CORP. BIO-ANCHOR, PRE-LOADED BIOABSORBABLE SUTURE ANCHOR 10/21/1998
K991715 LINVATEC CORP. BIOSTINGER-V BIOABSORBABLE MENISCAL REPAIR DEVICE 08/06/1999
K090835 LINVATEC CORP. CONMED LINVATEC BIO MINI-REVO SUTURE ANCHOR, MODEL C6170CR 06/22/2009
K090186 LINVATEC CORP. CONMED LINVATEC PALADIN, PRELOADED WITH TWO #2 HI-FI SUTURES 04/10/2009
K984171 LINVATEC CORP. ENDOPEARL 04/29/1999
K993339 LINVATEC CORP. ENDOPEARL WITH THREADER 12/10/1999
K003984 LINVATEC CORP. SUPER REVO SUTURE ANCHOR 03/19/2001
K041128 LINVATEC CORP. SUTURE ARROW 07/29/2004
K121890 LINVATEC CORPORATION D/B/A CONMED LINVATEC GENESYS PRESSFT SUTURE ANCHOR 08/22/2012
K181809 Medos International SARL GRYPHON« Anchors with DYNACORDÖ Suture 08/03/2018
K173859 Medos International SARL HEALIX ADVANCE Anchor with DYNACORD Suture 04/11/2018
K170639 Medos International SARL HEALIX ADVANCE Anchor with PERMATAPE Suture 05/18/2017
K171114 Medos International SARL HEALIX ADVANCE KNOTLESS Anchor 11/27/2017
K180101 Medos International SARL HEALIX ADVANCE KNOTLESS BR Anchor 05/10/2018
K160804 MEDOS INTERNATIONAL SARL INTRAFIX(TM) Advance Tibial Fastener System 07/19/2016
K002406 MITEK PRODUCTS MITEK 2GII MENISCAL REPAIR SYSTEM 02/15/2001
K964013 MITEK PRODUCTS MITEK ABSORBABLE TOGGLE ANCHOR 02/24/1997
K003076 MITEK PRODUCTS MITEK CUFFTACK 10/27/2000
K031519 MITEK WORLDWIDE CUFFLOK ANCHOR 06/06/2003
K161174 NANOVA BIOMATERIALS INC. Nanova Interference Screw 11/03/2016
K163672 NANOVA BIOMATERIALS, INC. Nanova Screw-In Suture Anchor, Nanova Push-In Suture Anchor 05/05/2017
K170868 S.B.M SAS Science for Bio Materials FIXIT Threaded Anchor System 11/30/2017
K180960 S.B.M. SAS Sciences for Bio Materials FIXIT / ComposiTCP Threaded Anchor System 07/25/2018
K122228 SBM SCIENCES FOR BIO MATERIALS LIGAFIX INTERFERENCE SCREW 10/03/2012
K063497 SCANDIUS BIOMEDICAL, INC. MODIFICATION TO SCANDIUS TRITIS ABSORBABLE TIBIAL RECONSTRUCTION SYSTEM 12/19/2006
K060522 SCANDIUS BIOMEDICAL, INC. SCANDIUS TRITIS ABSORBABLE TIBIAL RECONSTRUCTION SYSTEM 04/11/2006
K103309 SMITH & NEPHEW ENDOSCOPY, INC. OSTEORAPTOR CURVED 2.3 SUTURE ANCHORS 02/03/2011
K102982 SMITH & NEPHEW INC., ENDOSCOPY DIVISION ENDOBUTTON DIRECT 01/05/2011
K142948 Smith & Nephew, Inc BIOSURE REGENESORB interference Screw 01/13/2015
K143172 SMITH & NEPHEW, INC. ACL SMART System 02/04/2015
K123393 SMITH & NEPHEW, INC. HEALICOIL SUTURE ANCHOR WITH REGENESORB 04/11/2013
K101459 SMITH & NEPHEW, INC. OSTEORAPTOR II SUTURE ANCHOR OR TO BE DETERMINED MODEL: 72202764 72202765 72202766 72202767 72202768 72202769 72202770 01/27/2011
K011985 SMITH & NEPHEW, INC. SMITH & NEPHEW PHOENIX 5.0 ALLOGRAFT ANCHOR KIT 11/02/2001
K093844 SMITH & NEPHEW, INC. SMITH & NEPHEW TWINFIX ULTRA HA SUTURE ANCHOR 04/01/2010
K011299 SMITH & NEPHEW, INC. SMITH AND NEPHEW 5.00MM ABSORBABLE POLYMER ANCHOR 06/27/2001
K151105 Smith & Nephew, Inc. Smith and Nephew Suture Anchors - 5.0mm Absorbable Polymer Anchor, Smith and Nephew Suture Anchors - TAG Bioraptor Suture Anchor 7209317, 7209318, Smith and Nephew Suture Anchors - Bioraptor 2.3 PK Suture Anchor, Smith and Nephew Suture Anchors - Osteorap 07/28/2015
K032197 SMITH & NEPHEW, INC. TWIN FIX AB 6.5 MM SUTURE ANCHOR, MODELS 720209, 7210210, 7210211, 7210212 08/08/2003
K180361 Smith and Nephew, Inc MICRORAPTOR REGENESORB Suture Anchor 05/30/2018
K181746 Smith and Nephew, Inc. MICRORAPTOR Knotless Suture Anchor 09/28/2018
K171228 SportWelding GmbH Fiji Anchor 01/19/2018
K041307 Stryker Endoscopy MODIFICATION TO STRYKER XCEL ANCHOR SYSTEM 06/14/2004
K041305 Stryker Endoscopy STRYKER BIOZIP SUTURE ANCHOR SYSTEM 06/14/2004
K993061 STRYKER INSTRUMENTS STRYKER LEIBINGER RESORBABLE FIXATION SYSTEM 11/19/1999
K994161 SYNTHES (USA) SYNTHES BIORESORBABLE SUTURE ANCHOR 07/28/2000
K003743 SYNTHES (USA) SYNTHES MODIFIED BIORESORBABLE SUTURE ANCHOR SYSTEM 02/09/2001
K122635 TORNIER, INC. TORNIER INSITE FT BIOCOMPOSITE SUTURE ANCHOR 05/13/2013
K083268 TORNIER, INC. TORNIER, INC., INSITE SUTURE ANCHORS 02/12/2009
K965228 UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC FASTERNER, FIXATION, BIODEGRADABLE SOFT TISSUE 11/10/1997
K973281 UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC THE SURGICAL DYNAMICS* S.D. SORB* E-Z TAC* 11/03/1997
K950275 ZIMMER, INC. RESORBABLE SOFT TISSUE ATTACHMENT DEVICE 11/07/1995
K961789 ZIMMER, INC. RESORBABLE SOFT TISSUE ATTACHMENT DEVICE 08/01/1996
K162429 ZIPTEK, LLC ZipE Knotless Tissue Repair and Attachment Devices 03/13/2017


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