Orthopedic

MAI · Fastener, Fixation, Biodegradable, Soft Tissue

Orthopedic · 21 CFR 888.3030 · Class 2

Overview

Product CodeMAI
Device NameFastener, Fixation, Biodegradable, Soft Tissue
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 (219)

RecordDevice NameApplicantDecision DateDecision
K260294SF Push-in AnchorSurgical Fusion Technologies GmbHMar 27, 2026SESE
K254055OSSIOfiber® Suture AnchorOSSIO , Ltd.Feb 24, 2026SESE
K251680Biosteon® ScrewBiocomposites, Ltd.Feb 17, 2026SESE
K252946BioBrace® Extra-Articular Ligament Augmentation KitConmed CorporationOct 15, 2025SESE
K252022OSSIOfiber® Interference ScrewOSSIO , Ltd.Aug 19, 2025SESE
K251309OSSIOfiber® Suture AnchorOSSIO , Ltd.May 27, 2025SESE
K250544Knotilus+ Biocomposite Knotless AnchorStryker EndoscopyMay 23, 2025SESE
K250528Stryker AlphaVent™ Knotless SP Biocomposite AnchorStryker EndoscopyMay 21, 2025SESE
K243760OSSIOfiber® Suture Anchor 2.5-3.5 mmOSSIO , Ltd.Apr 3, 2025SESE
K250526Arthrex 4.75 mm Double Loaded Knotless Corkscrew Suture AnchorArthrex, Inc.Mar 14, 2025SESE
K243790GRYPHON™ X Anchor; HEALIX TRANSTEND™ AnchorDepuy MitekFeb 5, 2025SESE
K243467Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching)Osteonic Co., Ltd.Dec 3, 2024SESE
K241010HEALIX ADVANCE Knotless anchors; HEALIX ADVANCE Self-Punching anchorsDepuy MitekSep 11, 2024SESE
K241912BIOCHARGENanofiber Solutions, LLCJul 29, 2024SESE
K233971Arthrex AlloSync PushLock Suture AnchorArthrex, Inc.Jun 4, 2024SESE
K240288SF Push- in AnchorSurgical Fusion Technologies GmbHApr 1, 2024SESE
K240441MILAGRO Interference Screw; MILAGRO ADVANCE Interference ScrewDepuy MitekMar 15, 2024SESE
K240090Argo Knotless GENESYS AnchorConmed CorporationMar 5, 2024SESE
K232513X-Twist Biocomposite Suture AnchorParcus MedicalSep 18, 2023SESE
K231787ecoFIX®Science & Bio Materials (S.B.M.) SasJul 26, 2023SESE
K231641Rotium Bioresorbable WickNanofiber Solutions, LLCJul 5, 2023SESE
K230892Fixone Biocomposite AnchorAju Pharm Co., Ltd.Jun 9, 2023SESE
K231326Fix2Lock(Biocomposite medial, lateral, Biocombi Self Punching)Osteonic Co., Ltd.May 31, 2023SESE
K230394EUROSCREW NG; EUROSCREW TCP NGTeknimedMay 12, 2023SESE
K230435Arthrex 3.9 mm SwiveLock AnchorArthrex, Inc.Mar 17, 2023SESE
K221468Citregen™ Tendon Interference Screw (TIS), Citrelock™ Tendon Fixation Device, Citrespline™ and Citrelock™ ACL ImplantsAcuitive Technologies, Inc.Feb 14, 2023SESE
K220833Citregen Tendon Interference Screw, Citrelock, Citrefix, Citrespline ACL, and Citrelock ACLAcuitive Technologies, Inc.Nov 4, 2022SESE
K221128Arthrex ACL TightRope®, PCL TightRope®, and TightRope® IIArthrex, Inc.Oct 5, 2022SESE
K222263Arthrex Self Punching SwiveLock Suture AnchorsArthrex, Inc.Aug 26, 2022SESE
K221099Arthrex Self-Punching PushLock Suture AnchorArthrex, Inc.May 13, 2022SESE
K213958Bioabsorbable AnchorEmbody, Inc.Apr 8, 2022SESE
K213415OSSIOfiber Suture AnchorOSSIO , Ltd.Mar 28, 2022SESE
K203523Fixone hybrid knotless anchorAju Pharm Co., Ltd.Dec 25, 2021SESE
K212912OneFix Biocomposite Anchors, OneFix Biocomposite Small Anchors, OneFix All Suture Anchors, OneFix Interference Screws, OneFix Cannula SystemB-One Ortho, Corp.Nov 4, 2021SESE
K210122Sterile Bioabsorbable bone screw (Bioabsorbable ACL screw)Osteonic Co., Ltd.Aug 27, 2021SESE
K202806Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching)Osteonic Co., Ltd.Jun 17, 2021SESE
K203495Arthrex SwiveLock AnchorArthrex, Inc.Apr 19, 2021SESE
K210239CITRESPLINE and CITRELOCK ACL ImplantsAcuitive Technologies, Inc.Feb 24, 2021SESE
K203493MectaLock ExtensionMedacta International S.A.Feb 22, 2021SESE
K203334The Citrefix Knotless Suture AnchorAcuitive Technologies, Inc.Feb 5, 2021SESE
K202535Arthrex FastThread Interference ScrewArthrex, Inc.Nov 18, 2020SESE
K200725Citregen Tendon Interference Screw and CitrelockAcuitive TechnologiesOct 7, 2020SESE
K201749Arthrex SwiveLock AnchorArthrex, Inc.Aug 21, 2020SESE
K201786Arthrex Mini Hip PushLockArthrex, Inc.Jul 30, 2020SESE
K201414Rotium Bioresorbable WickNanofiber Solutions, LLCJun 25, 2020SESE
K193558HEALICOIL Knotless Suture AnchorsSmith & Nephew, Inc.Mar 18, 2020SESE
K192484Fixone Biocomposite AnchorAju Pharm Co., Ltd.Mar 11, 2020SESE
K192032Fixone Biocomposite Small AnchorAju Pharm Co., Ltd.Mar 3, 2020SESE
K193503Arthrex SwiveLock Suture AnchorArthrex, Inc.Jan 15, 2020SESE
K193157Arthrex 3.9mm Corkscrew Suture AnchorArthrex, Inc.Dec 12, 2019SESE
K192824Parcus Knotless AP Suture AnchorsParcus Medical, LLCNov 2, 2019SESE
K192532Arthrex SwiveLock AnchorArthrex, Inc.Oct 19, 2019SESE
K192441Arthrex SwiveLock AnchorsArthrex, Inc.Oct 17, 2019SESE
K191242HEALIX ADVANCE SP BIOCOMPOSITE AnchorMedos International SARLAug 22, 2019SESE
K191226Arthrex SwiveLock Suture AnchorArthrex, Inc.Jun 11, 2019SESE
K183501Parcus Twist AP Suture AnchorsParcus Medical, LLCMar 15, 2019SESE
K183236Rotium Bioresorbable WickNanofiber Solutions, LLCMar 11, 2019SESE
K183506HEALIX ADVANCE Anchor with DYNACORD SutureMedos International SARLFeb 14, 2019SESE
K180768Arthrex SwiveLock AnchorsArthrex, Inc.Dec 14, 2018SESE
K181746MICRORAPTOR Knotless Suture AnchorSmith and Nephew, Inc.Sep 28, 2018SESE
K181809GRYPHON® Anchors with DYNACORD™ SutureMedos International SARLAug 3, 2018SESE
K180960FIXIT / ComposiTCP Threaded Anchor SystemS.B.M. Sas Sciences For Bio MaterialsJul 25, 2018SESE
K180763CuffLink Implant System BiocompositeConmed CorporationJul 19, 2018SESE
K180594Knotless SutureTak AnchorsArthrex, Inc.Jun 22, 2018SESE
K180361MICRORAPTOR REGENESORB Suture AnchorSmith and Nephew, Inc.May 30, 2018SESE
K180662Arthrex FastThread Interference ScrewArthrex, Inc.May 22, 2018SESE
K180101HEALIX ADVANCE KNOTLESS BR AnchorMedos International SARLMay 10, 2018SESE
K173859HEALIX ADVANCE Anchor with DYNACORD SutureMedos International SARLApr 11, 2018SESE
K173788Arthrex Corkscrew FTArthrex, Inc.Mar 1, 2018SESE
K171228Fiji AnchorSportwelding GmbHJan 19, 2018SESE
K173240Arthrex PushLockArthrex, Inc.Jan 16, 2018SESE
K170868FIXIT Threaded Anchor SystemS.B.M Sas Science For Bio MaterialsNov 30, 2017SESE
K171114HEALIX ADVANCE KNOTLESS AnchorMedos International SARLNov 27, 2017SESE
K171592CrossFT™ Knotless Biocomposite Suture Anchor with Disposable DriverConmed CorporationAug 29, 2017SESE
K171299Fixone Biocomposite AnchorAju Pharm Co., Ltd.Aug 24, 2017SESE
K170639HEALIX ADVANCE Anchor with PERMATAPE SutureMedos International SARLMay 18, 2017SESE
K163672Nanova Screw-In Suture Anchor, Nanova Push-In Suture AnchorNanova Biomaterials, Inc.May 5, 2017SESE
K171141Arthrex SwiveLock AnchorsArthrex, Inc.May 4, 2017SESE
K170501CrossFT Knotless Biocomposite Suture Anchor with Disposable DriverConmed CorporationMar 17, 2017SESE
K162429ZipE Knotless Tissue Repair and Attachment DevicesZiptek, LLCMar 13, 2017SESE
K161174Nanova Interference ScrewNanova Biomaterials, Inc.Nov 3, 2016SESE
K160804INTRAFIX(TM) Advance Tibial Fastener SystemMedos International SARLJul 19, 2016SESE
K151342Arthrex SwiveLock AnchorsArthrex, Inc.Mar 24, 2016SESE
K150209Healix 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 QuickAnchor Plus Dual Suture, PanaLok RC QuickAnchor Plus w/Orthocord; PanaLok RC QuickAnchor Plus Dual Suture w/Orthocord, PanaLok Loop Anchor, Lupine Loop Anchor, PanaLok RC Lop Anchor, BioKnotless Anchor, BioKnotless RC Anchor, RC Loop AncDepuy Mitek, A Johnson and Johnson CompanyOct 6, 2015SESE
K151105Smith 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 - Osteoraptor Suture Anchor, Smith and Nephew Suture Anchors - Twinfix Ultra HA Suture Anchor, Smith and Nephew Suture Anchors - OSTEORAPTOR Curved Suture Anchors, Smith and Nephew Suture Anchors - Ultra Fast-Fix Meniscal Repair System, Ultra FaSmith & Nephew, Inc.Jul 28, 2015SESE
K143660Milagro / Milagro Advance Interference ScrewDepuy Mitek, A Johnson & Johnson CompanyMay 21, 2015SESE
K143172ACL SMART SystemSmith & Nephew, Inc.Feb 4, 2015SESE
K142948BIOSURE REGENESORB interference ScrewSmith & Nephew, Inc.Jan 13, 2015SESE
K140855ARTHREX SUTURETAK SUTURE ANCHORSArthrex, Inc.Dec 18, 2014SESE
K140643GRYPHON BR ANCHOR W/PROKNOT TECHNOLOGY,GRYPHON PEEK ANCHOR W/ PROKNOT TECHNOLOGYDepuy Mitek, A Johnson and Johnson CompanyJul 8, 2014SESE
K141259GRYPHON BR ANCHOR WITH PERMACORD, GRYPHON BR DS ANCHOR WITH PERMACORD,GRYPHON PEEK ANCHOR WITH PERMACORD, GRYPHON PEEKDepuy Mitek, A Johnson & Johnson CompanyJun 10, 2014SESE
K1337944.5MM HEALIX ADVANCE BR ANCHOR, WITH 2 OR 3 STRANDS OF #2 PERMACORD SUTURE, 5.5MM HEALIX ADVANCE BR ANCHOR, WITH 2 OR 3Depuy Mitek, A Johnson & Johnson CompanyFeb 4, 2014SESE
K132241GRYPHON BR ANCHOR W/ PROKNOT TECHNOLOGY, GRYPHON BR ANCHOR W/ PROKNOT TECHNOLOGY - HIP, GRYPHON PEEK ANCHOR W/ PROKNOT TDepuy Mitek, A Johnson & Johnson CompanyNov 5, 2013SESE
K130716BIORETEC ACTIVASCREW INTERFERENCEBioretec, Ltd.Aug 28, 2013SESE
K131974HEALIX ADVANCE KNOTLESS BR ANCHOR (6.5MM)Depuy Mitek, A Johnson & Johnson CompanyJul 25, 2013SESE
K130917HEALIX ADVANCE KNOTLESS BR ANCHORDepuy Mitek, A Johnson & Johnson CompanyMay 24, 2013SESE
K122635TORNIER INSITE FT BIOCOMPOSITE SUTURE ANCHORTornier, Inc.May 13, 2013SESE
K123393HEALICOIL SUTURE ANCHOR WITH REGENESORBSmith & Nephew, Inc.Apr 11, 2013SESE
K122869MILAGRO INTERFERENCE SCREWSDepuy Mitek, A Johnson & Johnson CompanyDec 13, 2012SESE
K122228LIGAFIX INTERFERENCE SCREWSbm Sciences For Bio MaterialsOct 3, 2012SESE
K121890GENESYS PRESSFT SUTURE ANCHORLinvatec Corporation D/B/A Conmed LinvatecAug 22, 2012SESE
K120589MILAGRO INTERFERENCE SCREWSDepuy Mitek, A Johnson & Johnson CompanyApr 24, 2012SESE
K120540BIOBOLTArthrex, Inc.Mar 20, 2012SESE
K120078HEALIX ADVANCE BR ANCHORDepuy Mitek Inc., Johnson and Johnson CompanyFeb 29, 2012SESE
K113534HEALIX KNOTLESS ANCHORDepuy Mitek, A Johnson & Johnson CompanyDec 20, 2011SESE
K112040ARTHREX BIOCOMPOSITE TRANSFIXArthrex, Inc.Dec 15, 2011SESE
K112249HEALIX KNOTLESS(TM) ANCHORDepuy Mitek, A Johnson & Johnson CompanyOct 25, 2011SESE
K103831DEPUY MITEK MILAGRO INTERFERENCE SCREW MODEL 231803, 231804, 231807, 231809Depuy Mitek, A Johnson & Johnson CompanyJul 21, 2011SESE
K110660ARTHREX BIOCOMPOSITE SUTURETAKArthrex, Inc.Mar 31, 2011SESE
K103309OSTEORAPTOR CURVED 2.3 SUTURE ANCHORSSmith & Nephew Endoscopy, Inc.Feb 3, 2011SESE
K101459OSTEORAPTOR II SUTURE ANCHOR OR TO BE DETERMINED MODEL: 72202764 72202765 72202766 72202767 72202768 72202769 72202770Smith & Nephew, Inc.Jan 27, 2011SESE
K101823ARTHREX SWIVELOCK ANCHORSArthrex, Inc.Jan 7, 2011SESE
K102982ENDOBUTTON DIRECTSmith & Nephew Inc., Endoscopy DivisionJan 5, 2011SESE
K101679ARTHREX PUSHLOCK ANCHORSArthrex, Inc.Oct 22, 2010SESE
K101100CROSSFT OC SUTURE ANCHOR MODE CFC-4502, CFC-5502, CFC-6502, CFC-4503, CFC-5503, CFC-6503Conmed LinvatecAug 26, 2010SESE
K100012GRYPHON T BR DS ANCHOR W/ORTHOCORD, GRYPHON T BR ANCHOR W /ORTHOCORD, GRYPHON P BR DS ANCHOR W/ORTHOCORD, GRYPHON P BR ADepuy Mitek, A Johnson & Johnson CompanyApr 30, 2010SESE
K093844SMITH & NEPHEW TWINFIX ULTRA HA SUTURE ANCHORSmith & Nephew, Inc.Apr 1, 2010SESE
K092898CONMED LINVATEC PRESTO PRELOADED WITH ONE OR TWO #2 HI-FI SUTURESConmed LinvatecOct 19, 2009SESE
K091844ARTHREX BIO-COMPOSITE SUTURETAK ANCHORSArthrex, Inc.Aug 28, 2009SESE
K091041RIGIDFIX BIOCRYL 2.7MM BTB (210815), FEMORAL 3.3MM ST (210816), AND TIBIAL 3.3MM ST (210817) CROSS PIN KITSDepuy Mitek, A Johnson & Johnson CompanyAug 7, 2009SESE
K090835CONMED LINVATEC BIO MINI-REVO SUTURE ANCHOR, MODEL C6170CRLinvatec Corp.Jun 22, 2009SESE
K090186CONMED LINVATEC PALADIN, PRELOADED WITH TWO #2 HI-FI SUTURESLinvatec Corp.Apr 10, 2009SESE
K090669RIGIDFIX BIOCRYL CROSS PIN KITSDepuy Mitek, A Johnson & Johnson CompanyApr 3, 2009SESE
K090124GRYPHON P BR DS ANCHOR W/ORTHOCORD,GRYPHON P BR ANCHOR W/ORTHOCORD, MODEL 210813,210814Depuy Mitek, A Johnson & Johnson CompanyMar 11, 2009SESE
K083268TORNIER, INC., INSITE SUTURE ANCHORSTornier, Inc.Feb 12, 2009SESE
K082810ARTHREX BIO-COMPOSITE SUTURE ANCHORS: ARTHREX BIO-COMPOSITE PUSHLOCK, BIO-COMPOSITE TAK AND BIO-COMPOSITE CORKSCREWArthrex, Inc.Jan 23, 2009SESE
K082999ARTHREX MENISCAL DART, ARTHREX MENISCAL DARTSTICK, ARTHREX CHONDRAL DARTArthrex, Inc.Dec 30, 2008SESE
K073412GRYPHON BR AND HEALIX BR ANCHORSDepuy Mitek, A Johnson & Johnson CompanyJan 17, 2008SESE
K071456ARTHREX PROSTOP PLUS ARTHROEREISIS SUBTALAR IMPLANTArthrex, Inc.Jan 17, 2008SESE
K071176MODIFICATION TO: ARTHREX INTERFERENCE SCREWArthrex, Inc.Aug 3, 2007SESE
K070925MODIFICATION TO: BIOKNOTLESS BR ANCHOR / LUPINE BR ANCHORDepuy Mitek, A Johnson & Johnson CompanyMay 2, 2007SESE
K070178AESCULAP RESORBABLE PIN, MODEL FR735Aesculap Implant System, Inc.Apr 30, 2007SESE
K053492BIODUCTBioduct, LLCApr 12, 2007SESE
K063497MODIFICATION TO SCANDIUS TRITIS ABSORBABLE TIBIAL RECONSTRUCTION SYSTEMScandius Biomedical, Inc.Dec 19, 2006SESE
K062466ARTHREX INTERFERENCE SCREWArthrex, Inc.Nov 29, 2006SESE
K062782INION ANCHRON PLUS BIODEGRADABLE ANCHOR SYSTEM, MODEL ANC-6001Inion OYNov 9, 2006SESE
K060522SCANDIUS TRITIS ABSORBABLE TIBIAL RECONSTRUCTION SYSTEMScandius Biomedical, Inc.Apr 11, 2006SESE
K052799MULTITAK 6.0 MM ABSORBABLE ANCHOR SYSTEMBonutti Research, Inc.Dec 16, 2005SESE
K051983MODEL 3000 AXYALOOP BIO-ABSORBABLE BONE ANCHORAxya Medical, Inc.Aug 5, 2005SESE
K051362INION ANCHRON BIODEGRADABLE ANCHOR SYSTEM, MODEL ANC-6000Inion OYAug 4, 2005SESE
K051219PUSHLOCKArthrex, Inc.Jun 29, 2005SESE
K051250AXYA, MODEL 6500 AXYALOOP BIO-ABSORBABLE BONE ANCHORAxya Medical, Inc.Jun 9, 2005SESE
K042966DUET SUTURE ANCHOR, MODELS BXS4216, BXS4216H; IMPACT SUTURE ANCHOR, MODELS BXS4218, BXS4218HLinvatec Biomaterials, Ltd.Nov 19, 2004SESE
K041698AXYA MEDICAL, INC. MODEL 5000 AXYALOOP BIO-ABSORBABLE BONE ANCHORAxya Medical, Inc.Oct 5, 2004SESE
K041128SUTURE ARROWLinvatec Corp.Jul 29, 2004SESE
K041307MODIFICATION TO STRYKER XCEL ANCHOR SYSTEMStryker EndoscopyJun 14, 2004SESE
K041305STRYKER BIOZIP SUTURE ANCHOR SYSTEMStryker EndoscopyJun 14, 2004SESE
K040827PANALOK LOOP ANCHORDepuy Mitek, A Johnson & Johnson CompanyApr 30, 2004SESE
K032197TWIN FIX AB 6.5 MM SUTURE ANCHOR, MODELS 720209, 7210210, 7210211, 7210212Smith & Nephew, Inc.Aug 8, 2003SESE
K0319812.4 SMARTNAIL, MODELS 532416, 532425, 532435, 532445Linvatec Biomaterials, Ltd.Jul 25, 2003SESE
K031519CUFFLOK ANCHORMitek WorldwideJun 6, 2003SESE
K011985SMITH & NEPHEW PHOENIX 5.0 ALLOGRAFT ANCHOR KITSmith & Nephew, Inc.Nov 2, 2001SESE
K012465MULTITAK SPLINTER 3.0 MM RESORBABLE ANCHORBonutti Research, Inc.Oct 29, 2001SESE
K013057BIOCUFF,C, MODELS 236018, 236028, 236036Bionx Implants, Inc.Oct 12, 2001SESE
K012334CONTOUR MENISCUS ARROW, MODELS 541110, 541113, AND 541116Bionx Implants, Inc.Sep 19, 2001SESE
K011495ARTHREX BIO-POST AND WASHERArthrex, Inc.Aug 1, 2001SESE
K011299SMITH AND NEPHEW 5.00MM ABSORBABLE POLYMER ANCHORSmith & Nephew, Inc.Jun 27, 2001SESE
K003984SUPER REVO SUTURE ANCHORLinvatec Corp.Mar 19, 2001SESE
K002406MITEK 2GII MENISCAL REPAIR SYSTEMMitek ProductsFeb 15, 2001SESE
K003743SYNTHES MODIFIED BIORESORBABLE SUTURE ANCHOR SYSTEMSynthes (Usa)Feb 9, 2001SESE
K003970CONTOUR LABRAL NAIL, MODEL 533520ABionx Implants, Inc.Jan 12, 2001SESE
K003273LACTOSORB SCREW ANCHORBiomet, Inc.Jan 11, 2001SESE
K003227BIO-ABSORBABLE CORKSCREW MODEL AR-1920BArthrex, Inc.Jan 8, 2001SESE
K003076MITEK CUFFTACKMitek ProductsOct 27, 2000SESE
K002413ULTRASORB SUTURE ANCHORLi Medical Technologies, Inc.Sep 19, 2000SESE
K002020LACTOSORB MENISCAL SCREWBiomet Manufacturing, Inc.Aug 25, 2000SESE
K994161SYNTHES BIORESORBABLE SUTURE ANCHORSynthes (Usa)Jul 28, 2000SESE
K001378BIOCUFF, MODELS 225718, 225728, 225736, 235718, 235728, 235736Bionx Implants, Inc.Jul 28, 2000SESE
K000506BIO-FASTAK SUTURE ANCHOR, MODEL AR-1324BArthrex, Inc.May 1, 2000SESE
K000616SMARTWEDGE ACL, MODELS 430623, 430628, 430723, 430728, 430823, 430828Bionx Implants, Ltd.Mar 23, 2000SESE
K990340ARTHREX PLA TISSUETAK, MODEL # AR-1940 BUArthrex, Inc.Jan 28, 2000SESE
K990987BIO-ABSORBABLE CORKSCREW, MODEL AR-1920BArthrex, Inc.Jan 13, 2000SESE
K994269TITAN RC TACKInnovasive Devices, Inc.Jan 10, 2000SESE
K993115MULTITAK SSBonutti Research, Inc.Dec 17, 1999SESE
K993339ENDOPEARL WITH THREADERLinvatec Corp.Dec 10, 1999SESE
K993074SMART NAIL MODELS 521516, 521520,521525, 531516, 531520. 531525Bionx Implants, Ltd.Dec 10, 1999SESE
K993073SMART SCREW ACL MODELS 237020, 237025, 237030, 238020, 238025, 238030, 239020, 239025, 239030Bionx Implants, Ltd.Dec 6, 1999SESE
K993061STRYKER LEIBINGER RESORBABLE FIXATION SYSTEMStryker InstrumentsNov 19, 1999SESE
K993453MENISCUS ARROW, MODELS 531110, 531113, 531116Bionx Implants, Ltd.Nov 9, 1999SESE
K993373ROTORBLADE SUTURE ANCHORLi Medical Technologies, Inc.Oct 27, 1999SESE
K992938ROTORBLADE SUTURE ANCHORLi Medical Technologies, Inc.Sep 23, 1999SESE
K992567ANATOMICAL BANKART TACK, MODEL 523520ABionx Implants, Ltd.Aug 27, 1999SESE
K983577ARTHREX MENISCAL DART SYSTEMArthrex, Inc.Aug 13, 1999SESE
K991715BIOSTINGER-V BIOABSORBABLE MENISCAL REPAIR DEVICELinvatec Corp.Aug 6, 1999SESE
K991009RC BUTTRESSBiomet, Inc.Jun 23, 1999SESE
K984171ENDOPEARLLinvatec Corp.Apr 29, 1999SESE
K983435ROTORBLADELi Medical Technologies, Inc.Apr 29, 1999SESE
K990999MODIFICATION OF: EBI SPINELINK SYSTEMElectro-Biology, Inc.Apr 14, 1999SESE
K990361HEADED BIO-ABSORBABLE CORKSCREW MODEL #AR-1921BUArthrex, Inc.Apr 14, 1999SESE
K983843BIO-BUTTON 6.5MM, BIO-BUTTON 8MM, MODEL #'S AR-2236B & AR-2238BArthrex, Inc.Mar 12, 1999SESE
K984490SUTURELESS ANCHORInnovasive Devices, Inc.Mar 1, 1999SESE
K982095LACTOSORB MENISCAL REPAIR DEVICEBiomet, Inc.Jan 27, 1999SESE
K983186BIO-ANCHOR, PRE-LOADED BIOABSORBABLE SUTURE ANCHORLinvatec Corp.Oct 21, 1998SESE
K982900PHANTOM SOFTHREAD SOFT TISSUE INTERFERENCE SCREWDepuy, Inc.Aug 31, 1998SESE
K981340INNOVASIVE DEVICES MENISCAL DART REPAIR SYSTEMInnovasive Devices, Inc.Jun 22, 1998SESE
K972783BIOFIX BIODEGRADABLE THREADED SUTURE ANCHORBionx Implants, Inc.Apr 14, 1998SESE
K974876BIONX DISTAL RADIUS SCREWBionx Implants, Inc.Mar 20, 1998SESE
K973381BIOROC EZ SUTURE BONE FASTENERInnovasive Devices, Inc.Feb 18, 1998SESE
K973849BIOABSORBABLE BANKART TACKHogan & HartsonJan 6, 1998SESE
K965228FASTERNER, FIXATION, BIODEGRADABLE SOFT TISSUEUnited States Surgical, A Division of Tyco HealthcNov 10, 1997SESE

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