Product Code: MAI FDA class 2 21 CFR 888.3030

Fastener, Fixation, Biodegradable, Soft Tissue

Orthopedic

The biodegradable soft tissue fixation fastener is a surgically implanted orthopedic device used to anchor soft tissue, such as tendons and ligaments, to bone during reconstructive procedures. It is classified as FDA Class II under regulation 21 CFR 888.3030, requiring 510(k) premarket clearance to demonstrate substantial equivalence to a legally marketed predicate device. The product code is MAI and it falls within the Orthopedic medical specialty. As an implanted device it carries an implant flag, and full GMP quality system requirements apply.

View on FDA

510(k)s

220

FEI Numbers

147

Registration Numbers

147

Unique Applicants

Years Active

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Basic Information

Product Code: MAI
Device Class: FDA class 2
Regulation Number: 888.3030
Medical Specialty: Orthopedic
Review Panel: OR
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✓

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 220 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K253931	Arthrex Bioabsorbable PushLock Suture Anchors	May 28, 2026	Substantially Equivalent	Arthrex, Inc.
K260294	SF Push-in Anchor	Mar 27, 2026	Substantially Equivalent	Surgical Fusion Technologies GmbH
K254055	OSSIOfiber® Suture Anchor	Feb 24, 2026	Substantially Equivalent	OSSIO , Ltd.
K251680	Biosteon® Screw	Feb 17, 2026	Substantially Equivalent	Biocomposites, Ltd.
K252946	BioBrace® Extra-Articular Ligament Augmentation Kit	Oct 15, 2025	Substantially Equivalent	Conmed Corporation
K252022	OSSIOfiber® Interference Screw	Aug 19, 2025	Substantially Equivalent	OSSIO , Ltd.
K251309	OSSIOfiber® Suture Anchor	May 27, 2025	Substantially Equivalent	OSSIO , Ltd.
K250544	Knotilus+ Biocomposite Knotless Anchor	May 23, 2025	Substantially Equivalent	Stryker Endoscopy
K250528	Stryker AlphaVent Knotless SP Biocomposite Anchor	May 21, 2025	Substantially Equivalent	Stryker Endoscopy
K243760	OSSIOfiber® Suture Anchor 2.5-3.5 mm	Apr 03, 2025	Substantially Equivalent	OSSIO , Ltd.
K250526	Arthrex 4.75 mm Double Loaded Knotless Corkscrew Suture Anchor	Mar 14, 2025	Substantially Equivalent	Arthrex, Inc.
K243790	GRYPHON X Anchor; HEALIX TRANSTEND Anchor	Feb 05, 2025	Substantially Equivalent	Depuy Mitek
K243467	Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching)	Dec 03, 2024	Substantially Equivalent	Osteonic Co., Ltd.
K241010	HEALIX ADVANCE Knotless anchors; HEALIX ADVANCE Self-Punching anchors	Sep 11, 2024	Substantially Equivalent	Depuy Mitek
K241912	BIOCHARGE	Jul 29, 2024	Substantially Equivalent	Nanofiber Solutions, LLC
K233971	Arthrex AlloSync PushLock Suture Anchor	Jun 04, 2024	Substantially Equivalent	Arthrex, Inc.
K240288	SF Push- in Anchor	Apr 01, 2024	Substantially Equivalent	Surgical Fusion Technologies GmbH
K240441	MILAGRO Interference Screw; MILAGRO ADVANCE Interference Screw	Mar 15, 2024	Substantially Equivalent	Depuy Mitek
K240090	Argo Knotless GENESYS Anchor	Mar 05, 2024	Substantially Equivalent	Conmed Corporation
K232513	X-Twist Biocomposite Suture Anchor	Sep 18, 2023	Substantially Equivalent	Parcus Medical
K231787	ecoFIX®	Jul 26, 2023	Substantially Equivalent	Science & Bio Materials (S.B.M.) Sas
K231641	Rotium Bioresorbable Wick	Jul 05, 2023	Substantially Equivalent	Nanofiber Solutions, LLC
K230892	Fixone Biocomposite Anchor	Jun 09, 2023	Substantially Equivalent	Aju Pharm Co., Ltd.
K231326	Fix2Lock(Biocomposite medial, lateral, Biocombi Self Punching)	May 31, 2023	Substantially Equivalent	Osteonic Co., Ltd.
K230394	EUROSCREW NG; EUROSCREW TCP NG	May 12, 2023	Substantially Equivalent	Teknimed
K230435	Arthrex 3.9 mm SwiveLock Anchor	Mar 17, 2023	Substantially Equivalent	Arthrex, Inc.
K221468	Citregen Tendon Interference Screw (TIS), Citrelock Tendon Fixation Device, Citrespline and Citrelock ACL Implants	Feb 14, 2023	Substantially Equivalent	Acuitive Technologies, Inc.
K220833	Citregen Tendon Interference Screw, Citrelock, Citrefix, Citrespline ACL, and Citrelock ACL	Nov 04, 2022	Substantially Equivalent	Acuitive Technologies, Inc.
K221128	Arthrex ACL TightRope®, PCL TightRope®, and TightRope® II	Oct 05, 2022	Substantially Equivalent	Arthrex, Inc.
K222263	Arthrex Self Punching SwiveLock Suture Anchors	Aug 26, 2022	Substantially Equivalent	Arthrex, Inc.
K221099	Arthrex Self-Punching PushLock Suture Anchor	May 13, 2022	Substantially Equivalent	Arthrex, Inc.
K213958	Bioabsorbable Anchor	Apr 08, 2022	Substantially Equivalent	Embody, Inc.
K213415	OSSIOfiber Suture Anchor	Mar 28, 2022	Substantially Equivalent	OSSIO , Ltd.
K203523	Fixone hybrid knotless anchor	Dec 25, 2021	Substantially Equivalent	Aju Pharm Co., Ltd.
K212912	OneFix Biocomposite Anchors, OneFix Biocomposite Small Anchors, OneFix All Suture Anchors, OneFix Interference Screws, OneFix Cannula System	Nov 04, 2021	Substantially Equivalent	B-One Ortho, Corp.
K210122	Sterile Bioabsorbable bone screw (Bioabsorbable ACL screw)	Aug 27, 2021	Substantially Equivalent	Osteonic Co., Ltd.
K202806	Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching)	Jun 17, 2021	Substantially Equivalent	Osteonic Co., Ltd.
K203495	Arthrex SwiveLock Anchor	Apr 19, 2021	Substantially Equivalent	Arthrex, Inc.
K210239	CITRESPLINE and CITRELOCK ACL Implants	Feb 24, 2021	Substantially Equivalent	Acuitive Technologies, Inc.
K203493	MectaLock Extension	Feb 22, 2021	Substantially Equivalent	Medacta International S.A.
K203334	The Citrefix Knotless Suture Anchor	Feb 05, 2021	Substantially Equivalent	Acuitive Technologies, Inc.
K202535	Arthrex FastThread Interference Screw	Nov 18, 2020	Substantially Equivalent	Arthrex, Inc.
K200725	Citregen Tendon Interference Screw and Citrelock	Oct 07, 2020	Substantially Equivalent	Acuitive Technologies
K201749	Arthrex SwiveLock Anchor	Aug 21, 2020	Substantially Equivalent	Arthrex, Inc.
K201786	Arthrex Mini Hip PushLock	Jul 30, 2020	Substantially Equivalent	Arthrex, Inc.
K201414	Rotium Bioresorbable Wick	Jun 25, 2020	Substantially Equivalent	Nanofiber Solutions, LLC
K193558	HEALICOIL Knotless Suture Anchors	Mar 18, 2020	Substantially Equivalent	Smith & Nephew, Inc.
K192484	Fixone Biocomposite Anchor	Mar 11, 2020	Substantially Equivalent	Aju Pharm Co., Ltd.
K192032	Fixone Biocomposite Small Anchor	Mar 03, 2020	Substantially Equivalent	Aju Pharm Co., Ltd.
K193503	Arthrex SwiveLock Suture Anchor	Jan 15, 2020	Substantially Equivalent	Arthrex, Inc.
K193157	Arthrex 3.9mm Corkscrew Suture Anchor	Dec 12, 2019	Substantially Equivalent	Arthrex, Inc.
K192824	Parcus Knotless AP Suture Anchors	Nov 02, 2019	Substantially Equivalent	Parcus Medical, LLC
K192532	Arthrex SwiveLock Anchor	Oct 19, 2019	Substantially Equivalent	Arthrex, Inc.
K192441	Arthrex SwiveLock Anchors	Oct 17, 2019	Substantially Equivalent	Arthrex, Inc.
K191242	HEALIX ADVANCE SP BIOCOMPOSITE Anchor	Aug 22, 2019	Substantially Equivalent	Medos International SARL
K191226	Arthrex SwiveLock Suture Anchor	Jun 11, 2019	Substantially Equivalent	Arthrex, Inc.
K183501	Parcus Twist AP Suture Anchors	Mar 15, 2019	Substantially Equivalent	Parcus Medical, LLC
K183236	Rotium Bioresorbable Wick	Mar 11, 2019	Substantially Equivalent	Nanofiber Solutions, LLC
K183506	HEALIX ADVANCE Anchor with DYNACORD Suture	Feb 14, 2019	Substantially Equivalent	Medos International SARL
K180768	Arthrex SwiveLock Anchors	Dec 14, 2018	Substantially Equivalent	Arthrex, Inc.
K181746	MICRORAPTOR Knotless Suture Anchor	Sep 28, 2018	Substantially Equivalent	Smith and Nephew, Inc.
K181809	GRYPHON® Anchors with DYNACORD Suture	Aug 03, 2018	Substantially Equivalent	Medos International SARL
K180960	FIXIT / ComposiTCP Threaded Anchor System	Jul 25, 2018	Substantially Equivalent	S.B.M. Sas Sciences For Bio Materials
K180763	CuffLink Implant System Biocomposite	Jul 19, 2018	Substantially Equivalent	Conmed Corporation
K180594	Knotless SutureTak Anchors	Jun 22, 2018	Substantially Equivalent	Arthrex, Inc.
K180361	MICRORAPTOR REGENESORB Suture Anchor	May 30, 2018	Substantially Equivalent	Smith and Nephew, Inc.
K180662	Arthrex FastThread Interference Screw	May 22, 2018	Substantially Equivalent	Arthrex, Inc.
K180101	HEALIX ADVANCE KNOTLESS BR Anchor	May 10, 2018	Substantially Equivalent	Medos International SARL
K173859	HEALIX ADVANCE Anchor with DYNACORD Suture	Apr 11, 2018	Substantially Equivalent	Medos International SARL
K173788	Arthrex Corkscrew FT	Mar 01, 2018	Substantially Equivalent	Arthrex, Inc.
K171228	Fiji Anchor	Jan 19, 2018	Substantially Equivalent	Sportwelding GmbH
K173240	Arthrex PushLock	Jan 16, 2018	Substantially Equivalent	Arthrex, Inc.
K170868	FIXIT Threaded Anchor System	Nov 30, 2017	Substantially Equivalent	S.B.M Sas Science For Bio Materials
K171114	HEALIX ADVANCE KNOTLESS Anchor	Nov 27, 2017	Substantially Equivalent	Medos International SARL
K171592	CrossFT Knotless Biocomposite Suture Anchor with Disposable Driver	Aug 29, 2017	Substantially Equivalent	Conmed Corporation
K171299	Fixone Biocomposite Anchor	Aug 24, 2017	Substantially Equivalent	Aju Pharm Co., Ltd.
K170639	HEALIX ADVANCE Anchor with PERMATAPE Suture	May 18, 2017	Substantially Equivalent	Medos International SARL
K163672	Nanova Screw-In Suture Anchor, Nanova Push-In Suture Anchor	May 05, 2017	Substantially Equivalent	Nanova Biomaterials, Inc.
K171141	Arthrex SwiveLock Anchors	May 04, 2017	Substantially Equivalent	Arthrex, Inc.
K170501	CrossFT Knotless Biocomposite Suture Anchor with Disposable Driver	Mar 17, 2017	Substantially Equivalent	Conmed Corporation
K162429	ZipE Knotless Tissue Repair and Attachment Devices	Mar 13, 2017	Substantially Equivalent	Ziptek, LLC
K161174	Nanova Interference Screw	Nov 03, 2016	Substantially Equivalent	Nanova Biomaterials, Inc.
K160804	INTRAFIX(TM) Advance Tibial Fastener System	Jul 19, 2016	Substantially Equivalent	Medos International SARL
K151342	Arthrex SwiveLock Anchors	Mar 24, 2016	Substantially Equivalent	Arthrex, Inc.
K150209	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 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 Anc	Oct 06, 2015	Substantially Equivalent	Depuy Mitek, A Johnson and Johnson Company
K151105	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 - 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 Fa	Jul 28, 2015	Substantially Equivalent	Smith & Nephew, Inc.
K143660	Milagro / Milagro Advance Interference Screw	May 21, 2015	Substantially Equivalent	Depuy Mitek, A Johnson & Johnson Company
K143172	ACL SMART System	Feb 04, 2015	Substantially Equivalent	Smith & Nephew, Inc.
K142948	BIOSURE REGENESORB interference Screw	Jan 13, 2015	Substantially Equivalent	Smith & Nephew, Inc.
K140855	ARTHREX SUTURETAK SUTURE ANCHORS	Dec 18, 2014	Substantially Equivalent	Arthrex, Inc.
K140643	GRYPHON BR ANCHOR W/PROKNOT TECHNOLOGY,GRYPHON PEEK ANCHOR W/ PROKNOT TECHNOLOGY	Jul 08, 2014	Substantially Equivalent	Depuy Mitek, A Johnson and Johnson Company
K141259	GRYPHON BR ANCHOR WITH PERMACORD, GRYPHON BR DS ANCHOR WITH PERMACORD,GRYPHON PEEK ANCHOR WITH PERMACORD, GRYPHON PEEK	Jun 10, 2014	Substantially Equivalent	Depuy Mitek, A Johnson & Johnson Company
K133794	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	Feb 04, 2014	Substantially Equivalent	Depuy Mitek, A Johnson & Johnson Company
K132241	GRYPHON BR ANCHOR W/ PROKNOT TECHNOLOGY, GRYPHON BR ANCHOR W/ PROKNOT TECHNOLOGY - HIP, GRYPHON PEEK ANCHOR W/ PROKNOT T	Nov 05, 2013	Substantially Equivalent	Depuy Mitek, A Johnson & Johnson Company
K130716	BIORETEC ACTIVASCREW INTERFERENCE	Aug 28, 2013	Substantially Equivalent	Bioretec, Ltd.
K131974	HEALIX ADVANCE KNOTLESS BR ANCHOR (6.5MM)	Jul 25, 2013	Substantially Equivalent	Depuy Mitek, A Johnson & Johnson Company
K130917	HEALIX ADVANCE KNOTLESS BR ANCHOR	May 24, 2013	Substantially Equivalent	Depuy Mitek, A Johnson & Johnson Company
K122635	TORNIER INSITE FT BIOCOMPOSITE SUTURE ANCHOR	May 13, 2013	Substantially Equivalent	Tornier, Inc.
K123393	HEALICOIL SUTURE ANCHOR WITH REGENESORB	Apr 11, 2013	Substantially Equivalent	Smith & Nephew, Inc.
K122869	MILAGRO INTERFERENCE SCREWS	Dec 13, 2012	Substantially Equivalent	Depuy Mitek, A Johnson & Johnson Company
K122228	LIGAFIX INTERFERENCE SCREW	Oct 03, 2012	Substantially Equivalent	Sbm Sciences For Bio Materials
K121890	GENESYS PRESSFT SUTURE ANCHOR	Aug 22, 2012	Substantially Equivalent	Linvatec Corporation D/B/A Conmed Linvatec
K120589	MILAGRO INTERFERENCE SCREWS	Apr 24, 2012	Substantially Equivalent	Depuy Mitek, A Johnson & Johnson Company
K120540	BIOBOLT	Mar 20, 2012	Substantially Equivalent	Arthrex, Inc.
K120078	HEALIX ADVANCE BR ANCHOR	Feb 29, 2012	Substantially Equivalent	Depuy Mitek Inc., Johnson and Johnson Company
K113534	HEALIX KNOTLESS ANCHOR	Dec 20, 2011	Substantially Equivalent	Depuy Mitek, A Johnson & Johnson Company
K112040	ARTHREX BIOCOMPOSITE TRANSFIX	Dec 15, 2011	Substantially Equivalent	Arthrex, Inc.
K112249	HEALIX KNOTLESS(TM) ANCHOR	Oct 25, 2011	Substantially Equivalent	Depuy Mitek, A Johnson & Johnson Company
K103831	DEPUY MITEK MILAGRO INTERFERENCE SCREW MODEL 231803, 231804, 231807, 231809	Jul 21, 2011	Substantially Equivalent	Depuy Mitek, A Johnson & Johnson Company
K110660	ARTHREX BIOCOMPOSITE SUTURETAK	Mar 31, 2011	Substantially Equivalent	Arthrex, Inc.
K103309	OSTEORAPTOR CURVED 2.3 SUTURE ANCHORS	Feb 03, 2011	Substantially Equivalent	Smith & Nephew Endoscopy, Inc.
K101459	OSTEORAPTOR II SUTURE ANCHOR OR TO BE DETERMINED MODEL: 72202764 72202765 72202766 72202767 72202768 72202769 72202770	Jan 27, 2011	Substantially Equivalent	Smith & Nephew, Inc.
K101823	ARTHREX SWIVELOCK ANCHORS	Jan 07, 2011	Substantially Equivalent	Arthrex, Inc.
K102982	ENDOBUTTON DIRECT	Jan 05, 2011	Substantially Equivalent	Smith & Nephew Inc., Endoscopy Division
K101679	ARTHREX PUSHLOCK ANCHORS	Oct 22, 2010	Substantially Equivalent	Arthrex, Inc.
K101100	CROSSFT OC SUTURE ANCHOR MODE CFC-4502, CFC-5502, CFC-6502, CFC-4503, CFC-5503, CFC-6503	Aug 26, 2010	Substantially Equivalent	Conmed Linvatec
K100012	GRYPHON T BR DS ANCHOR W/ORTHOCORD, GRYPHON T BR ANCHOR W /ORTHOCORD, GRYPHON P BR DS ANCHOR W/ORTHOCORD, GRYPHON P BR A	Apr 30, 2010	Substantially Equivalent	Depuy Mitek, A Johnson & Johnson Company
K093844	SMITH & NEPHEW TWINFIX ULTRA HA SUTURE ANCHOR	Apr 01, 2010	Substantially Equivalent	Smith & Nephew, Inc.
K092898	CONMED LINVATEC PRESTO PRELOADED WITH ONE OR TWO #2 HI-FI SUTURES	Oct 19, 2009	Substantially Equivalent	Conmed Linvatec
K091844	ARTHREX BIO-COMPOSITE SUTURETAK ANCHORS	Aug 28, 2009	Substantially Equivalent	Arthrex, Inc.
K091041	RIGIDFIX BIOCRYL 2.7MM BTB (210815), FEMORAL 3.3MM ST (210816), AND TIBIAL 3.3MM ST (210817) CROSS PIN KITS	Aug 07, 2009	Substantially Equivalent	Depuy Mitek, A Johnson & Johnson Company
K090835	CONMED LINVATEC BIO MINI-REVO SUTURE ANCHOR, MODEL C6170CR	Jun 22, 2009	Substantially Equivalent	Linvatec Corp.
K090186	CONMED LINVATEC PALADIN, PRELOADED WITH TWO #2 HI-FI SUTURES	Apr 10, 2009	Substantially Equivalent	Linvatec Corp.
K090669	RIGIDFIX BIOCRYL CROSS PIN KITS	Apr 03, 2009	Substantially Equivalent	Depuy Mitek, A Johnson & Johnson Company
K090124	GRYPHON P BR DS ANCHOR W/ORTHOCORD,GRYPHON P BR ANCHOR W/ORTHOCORD, MODEL 210813,210814	Mar 11, 2009	Substantially Equivalent	Depuy Mitek, A Johnson & Johnson Company
K083268	TORNIER, INC., INSITE SUTURE ANCHORS	Feb 12, 2009	Substantially Equivalent	Tornier, Inc.
K082810	ARTHREX BIO-COMPOSITE SUTURE ANCHORS: ARTHREX BIO-COMPOSITE PUSHLOCK, BIO-COMPOSITE TAK AND BIO-COMPOSITE CORKSCREW	Jan 23, 2009	Substantially Equivalent	Arthrex, Inc.
K082999	ARTHREX MENISCAL DART, ARTHREX MENISCAL DARTSTICK, ARTHREX CHONDRAL DART	Dec 30, 2008	Substantially Equivalent	Arthrex, Inc.
K073412	GRYPHON BR AND HEALIX BR ANCHORS	Jan 17, 2008	Substantially Equivalent	Depuy Mitek, A Johnson & Johnson Company
K071456	ARTHREX PROSTOP PLUS ARTHROEREISIS SUBTALAR IMPLANT	Jan 17, 2008	Substantially Equivalent	Arthrex, Inc.
K071176	MODIFICATION TO: ARTHREX INTERFERENCE SCREW	Aug 03, 2007	Substantially Equivalent	Arthrex, Inc.
K070925	MODIFICATION TO: BIOKNOTLESS BR ANCHOR / LUPINE BR ANCHOR	May 02, 2007	Substantially Equivalent	Depuy Mitek, A Johnson & Johnson Company
K070178	AESCULAP RESORBABLE PIN, MODEL FR735	Apr 30, 2007	Substantially Equivalent	Aesculap Implant System, Inc.
K053492	BIODUCT	Apr 12, 2007	Substantially Equivalent	Bioduct, LLC
K063497	MODIFICATION TO SCANDIUS TRITIS ABSORBABLE TIBIAL RECONSTRUCTION SYSTEM	Dec 19, 2006	Substantially Equivalent	Scandius Biomedical, Inc.
K062466	ARTHREX INTERFERENCE SCREW	Nov 29, 2006	Substantially Equivalent	Arthrex, Inc.
K062782	INION ANCHRON PLUS BIODEGRADABLE ANCHOR SYSTEM, MODEL ANC-6001	Nov 09, 2006	Substantially Equivalent	Inion OY
K060522	SCANDIUS TRITIS ABSORBABLE TIBIAL RECONSTRUCTION SYSTEM	Apr 11, 2006	Substantially Equivalent	Scandius Biomedical, Inc.
K052799	MULTITAK 6.0 MM ABSORBABLE ANCHOR SYSTEM	Dec 16, 2005	Substantially Equivalent	Bonutti Research, Inc.
K051983	MODEL 3000 AXYALOOP BIO-ABSORBABLE BONE ANCHOR	Aug 05, 2005	Substantially Equivalent	Axya Medical, Inc.
K051362	INION ANCHRON BIODEGRADABLE ANCHOR SYSTEM, MODEL ANC-6000	Aug 04, 2005	Substantially Equivalent	Inion OY
K051219	PUSHLOCK	Jun 29, 2005	Substantially Equivalent	Arthrex, Inc.
K051250	AXYA, MODEL 6500 AXYALOOP BIO-ABSORBABLE BONE ANCHOR	Jun 09, 2005	Substantially Equivalent	Axya Medical, Inc.
K042966	DUET SUTURE ANCHOR, MODELS BXS4216, BXS4216H; IMPACT SUTURE ANCHOR, MODELS BXS4218, BXS4218H	Nov 19, 2004	Substantially Equivalent	Linvatec Biomaterials, Ltd.
K041698	AXYA MEDICAL, INC. MODEL 5000 AXYALOOP BIO-ABSORBABLE BONE ANCHOR	Oct 05, 2004	Substantially Equivalent	Axya Medical, Inc.
K041128	SUTURE ARROW	Jul 29, 2004	Substantially Equivalent	Linvatec Corp.
K041307	MODIFICATION TO STRYKER XCEL ANCHOR SYSTEM	Jun 14, 2004	Substantially Equivalent	Stryker Endoscopy
K041305	STRYKER BIOZIP SUTURE ANCHOR SYSTEM	Jun 14, 2004	Substantially Equivalent	Stryker Endoscopy
K040827	PANALOK LOOP ANCHOR	Apr 30, 2004	Substantially Equivalent	Depuy Mitek, A Johnson & Johnson Company
K032197	TWIN FIX AB 6.5 MM SUTURE ANCHOR, MODELS 720209, 7210210, 7210211, 7210212	Aug 08, 2003	Substantially Equivalent	Smith & Nephew, Inc.
K031981	2.4 SMARTNAIL, MODELS 532416, 532425, 532435, 532445	Jul 25, 2003	Substantially Equivalent	Linvatec Biomaterials, Ltd.
K031519	CUFFLOK ANCHOR	Jun 06, 2003	Substantially Equivalent	Mitek Worldwide
K011985	SMITH & NEPHEW PHOENIX 5.0 ALLOGRAFT ANCHOR KIT	Nov 02, 2001	Substantially Equivalent	Smith & Nephew, Inc.
K012465	MULTITAK SPLINTER 3.0 MM RESORBABLE ANCHOR	Oct 29, 2001	Substantially Equivalent	Bonutti Research, Inc.
K013057	BIOCUFF,C, MODELS 236018, 236028, 236036	Oct 12, 2001	Substantially Equivalent	Bionx Implants, Inc.
K012334	CONTOUR MENISCUS ARROW, MODELS 541110, 541113, AND 541116	Sep 19, 2001	Substantially Equivalent	Bionx Implants, Inc.
K011495	ARTHREX BIO-POST AND WASHER	Aug 01, 2001	Substantially Equivalent	Arthrex, Inc.
K011299	SMITH AND NEPHEW 5.00MM ABSORBABLE POLYMER ANCHOR	Jun 27, 2001	Substantially Equivalent	Smith & Nephew, Inc.
K003984	SUPER REVO SUTURE ANCHOR	Mar 19, 2001	Substantially Equivalent	Linvatec Corp.
K002406	MITEK 2GII MENISCAL REPAIR SYSTEM	Feb 15, 2001	Substantially Equivalent	Mitek Products
K003743	SYNTHES MODIFIED BIORESORBABLE SUTURE ANCHOR SYSTEM	Feb 09, 2001	Substantially Equivalent	Synthes (Usa)
K003970	CONTOUR LABRAL NAIL, MODEL 533520A	Jan 12, 2001	Substantially Equivalent	Bionx Implants, Inc.
K003273	LACTOSORB SCREW ANCHOR	Jan 11, 2001	Substantially Equivalent	Biomet, Inc.
K003227	BIO-ABSORBABLE CORKSCREW MODEL AR-1920B	Jan 08, 2001	Substantially Equivalent	Arthrex, Inc.
K003076	MITEK CUFFTACK	Oct 27, 2000	Substantially Equivalent	Mitek Products
K002413	ULTRASORB SUTURE ANCHOR	Sep 19, 2000	Substantially Equivalent	Li Medical Technologies, Inc.
K002020	LACTOSORB MENISCAL SCREW	Aug 25, 2000	Substantially Equivalent	Biomet Manufacturing, Inc.
K994161	SYNTHES BIORESORBABLE SUTURE ANCHOR	Jul 28, 2000	Substantially Equivalent	Synthes (Usa)
K001378	BIOCUFF, MODELS 225718, 225728, 225736, 235718, 235728, 235736	Jul 28, 2000	Substantially Equivalent	Bionx Implants, Inc.
K000506	BIO-FASTAK SUTURE ANCHOR, MODEL AR-1324B	May 01, 2000	Substantially Equivalent	Arthrex, Inc.
K000616	SMARTWEDGE ACL, MODELS 430623, 430628, 430723, 430728, 430823, 430828	Mar 23, 2000	Substantially Equivalent	Bionx Implants, Ltd.
K990340	ARTHREX PLA TISSUETAK, MODEL # AR-1940 BU	Jan 28, 2000	Substantially Equivalent	Arthrex, Inc.
K990987	BIO-ABSORBABLE CORKSCREW, MODEL AR-1920B	Jan 13, 2000	Substantially Equivalent	Arthrex, Inc.
K994269	TITAN RC TACK	Jan 10, 2000	Substantially Equivalent	Innovasive Devices, Inc.
K993115	MULTITAK SS	Dec 17, 1999	Substantially Equivalent	Bonutti Research, Inc.
K993339	ENDOPEARL WITH THREADER	Dec 10, 1999	Substantially Equivalent	Linvatec Corp.
K993074	SMART NAIL MODELS 521516, 521520,521525, 531516, 531520. 531525	Dec 10, 1999	Substantially Equivalent	Bionx Implants, Ltd.
K993073	SMART SCREW ACL MODELS 237020, 237025, 237030, 238020, 238025, 238030, 239020, 239025, 239030	Dec 06, 1999	Substantially Equivalent	Bionx Implants, Ltd.
K993061	STRYKER LEIBINGER RESORBABLE FIXATION SYSTEM	Nov 19, 1999	Substantially Equivalent	Stryker Instruments
K993453	MENISCUS ARROW, MODELS 531110, 531113, 531116	Nov 09, 1999	Substantially Equivalent	Bionx Implants, Ltd.
K993373	ROTORBLADE SUTURE ANCHOR	Oct 27, 1999	Substantially Equivalent	Li Medical Technologies, Inc.
K992938	ROTORBLADE SUTURE ANCHOR	Sep 23, 1999	Substantially Equivalent	Li Medical Technologies, Inc.
K992567	ANATOMICAL BANKART TACK, MODEL 523520A	Aug 27, 1999	Substantially Equivalent	Bionx Implants, Ltd.
K983577	ARTHREX MENISCAL DART SYSTEM	Aug 13, 1999	Substantially Equivalent	Arthrex, Inc.
K991715	BIOSTINGER-V BIOABSORBABLE MENISCAL REPAIR DEVICE	Aug 06, 1999	Substantially Equivalent	Linvatec Corp.
K991009	RC BUTTRESS	Jun 23, 1999	Substantially Equivalent	Biomet, Inc.
K984171	ENDOPEARL	Apr 29, 1999	Substantially Equivalent	Linvatec Corp.
K983435	ROTORBLADE	Apr 29, 1999	Substantially Equivalent	Li Medical Technologies, Inc.
K990999	MODIFICATION OF: EBI SPINELINK SYSTEM	Apr 14, 1999	Substantially Equivalent	Electro-Biology, Inc.
K990361	HEADED BIO-ABSORBABLE CORKSCREW MODEL #AR-1921BU	Apr 14, 1999	Substantially Equivalent	Arthrex, Inc.
K983843	BIO-BUTTON 6.5MM, BIO-BUTTON 8MM, MODEL #'S AR-2236B & AR-2238B	Mar 12, 1999	Substantially Equivalent	Arthrex, Inc.
K984490	SUTURELESS ANCHOR	Mar 01, 1999	Substantially Equivalent	Innovasive Devices, Inc.
K982095	LACTOSORB MENISCAL REPAIR DEVICE	Jan 27, 1999	Substantially Equivalent	Biomet, Inc.
K983186	BIO-ANCHOR, PRE-LOADED BIOABSORBABLE SUTURE ANCHOR	Oct 21, 1998	Substantially Equivalent	Linvatec Corp.
K982900	PHANTOM SOFTHREAD SOFT TISSUE INTERFERENCE SCREW	Aug 31, 1998	Substantially Equivalent	Depuy, Inc.
K981340	INNOVASIVE DEVICES MENISCAL DART REPAIR SYSTEM	Jun 22, 1998	Substantially Equivalent	Innovasive Devices, Inc.
K972783	BIOFIX BIODEGRADABLE THREADED SUTURE ANCHOR	Apr 14, 1998	Substantially Equivalent	Bionx Implants, Inc.
K974876	BIONX DISTAL RADIUS SCREW	Mar 20, 1998	Substantially Equivalent	Bionx Implants, Inc.
K973381	BIOROC EZ SUTURE BONE FASTENER	Feb 18, 1998	Substantially Equivalent	Innovasive Devices, Inc.
K973849	BIOABSORBABLE BANKART TACK	Jan 06, 1998	Substantially Equivalent	Hogan & Hartson
K965228	FASTERNER, FIXATION, BIODEGRADABLE SOFT TISSUE	Nov 10, 1997	Substantially Equivalent	United States Surgical, A Division of Tyco Healthc
K973281	THE SURGICAL DYNAMICS* S.D. SORB* E-Z TAC*	Nov 03, 1997	Substantially Equivalent	United States Surgical, A Division of Tyco Healthc
K971358	BIO-INTERFERENCE SCREW, 7 MM, 8 MM, 9 MM	Jul 09, 1997	Substantially Equivalent	Arthrex, Inc.
K970896	MITEK 3.5 MM PANALOK WEDGE ABSORBABLE SUTURE ANCHOR SYSTEM	Jun 09, 1997	Substantially Equivalent	ETHICON, Inc.
K964805	BIO-ANCHOR	Jun 09, 1997	Substantially Equivalent	Linvatec Corp.
K963369	BIO-ANCHOR	May 22, 1997	Substantially Equivalent	Linvatec Corp.
K963396	BIOSPHERE SUTURE ANCHOR	May 06, 1997	Substantially Equivalent	Instrument Makar, Inc.
K964013	MITEK ABSORBABLE TOGGLE ANCHOR	Feb 24, 1997	Substantially Equivalent	Mitek Products
K964521	DEPUY DUPONT PHANTOM SUTURE ANCHOR	Feb 06, 1997	Substantially Equivalent	Depuy, Inc.
K961789	RESORBABLE SOFT TISSUE ATTACHMENT DEVICE	Aug 01, 1996	Substantially Equivalent	Zimmer, Inc.
K960555	BIOASBSORBABLE MINI-SCREW SUTURE ANCHOR	Jul 09, 1996	Substantially Equivalent	Instrument Makar, Inc.
K955768	BIOFIX BIODEGRADABLE MENISCUS ARROW SYSTEM	Mar 04, 1996	Substantially Equivalent for Some Indications	Bioscience, Inc.
K955486	BIO-ANCHOR	Feb 29, 1996	Substantially Equivalent for Some Indications	Linvatec Corp.
K952687	PANALOK WEDGE ABSORABLE SUTURE ANCHOR SYSTEM	Feb 06, 1996	Substantially Equivalent for Some Indications	ETHICON, Inc.
K955003	BIOFIX BIODEGRADABLE SELF-REINFORCED POLY-L-LACTIDE (SR-PLLA) MINI-TACK	Jan 31, 1996	Substantially Equivalent	Bioscience, Inc.
K944544	ABSORBABLE BONE SCREW	Jan 26, 1996	Substantially Equivalent	Johnson & Johnson Professionals, Inc.
K950275	RESORBABLE SOFT TISSUE ATTACHMENT DEVICE	Nov 07, 1995	Substantially Equivalent for Some Indications	Zimmer, Inc.
K952471	BIOFIX BIOABSORABABLE SELF-REINFORCED POLY-L-LACTIDE, THREADED FIXATION ROD	Aug 07, 1995	Substantially Equivalent	Bioscience, Inc.
K943249	BIOABSORBABLE INTERFERENCE SCREW	Jul 31, 1995	Substantially Equivalent	Instrument Makar, Inc.
K933948	ACUFEX ENDOBUTTON SYSTEM	Jul 21, 1994	Substantially Equivalent	Acufex Microsurgical, Inc.