JDR · Staple, Fixation, Bone
Orthopedic · 21 CFR 888.3030 · Class 2
Overview
| Product Code | JDR |
|---|---|
| Device Name | Staple, Fixation, Bone |
| Regulation | 21 CFR 888.3030 |
| Device Class | Class 2 |
| Review Panel | Orthopedic |
| Implant | Yes |
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 (231)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K250712 | Linkt Compression Staple System | Trax Surgical | May 14, 2025 | SESE |
| K243888 | Medline UNITE® REFLEX® Hybrid Nitinol Implant System | Medline Industries, LP | Apr 11, 2025 | SESE |
| K243742 | Arthrex DynaNite Nitinol Staples | Arthrex, Inc. | Jan 31, 2025 | SESE |
| K243658 | TMC Compression Implant System | Treace Medical Concepts | Dec 26, 2024 | SESE |
| K242415 | TMC Compression Implant System | Treace Medical Concepts | Sep 6, 2024 | SESE |
| K240212 | COGNiTiON Staple System | Ortho Solutions UK , Ltd. | Feb 23, 2024 | SESE |
| K232990 | ATOMIC Nitinol Fixation System | Rmr Ortho, LLC | Jan 12, 2024 | SESE |
| K230724 | arcad® 2.0 Duo & Quadro osteosynthesis compressive staples | Novastep | Dec 4, 2023 | SESE |
| K232905 | Medline UNITE® REFLEX® Nitinol Staple Kit | Medline Industries, LP | Oct 19, 2023 | SESE |
| K232324 | StealthFix Intraosseous Fixation System | Medartis, Inc. | Aug 30, 2023 | SESE |
| K232387 | Treace Medical Concepts (TMC) Compression Implant System | Treace Medical Concepts | Aug 28, 2023 | SESE |
| K231493 | NITINEX Memory Compression Staple | Vilex, LLC | Aug 11, 2023 | SESE |
| K231885 | Medline UNITE® REFLEX® Nitinol Staple System | Medline Industries, LP | Aug 9, 2023 | SESE |
| K231458 | Extremity Staple | Restor3D | Aug 3, 2023 | SESE |
| K230550 | JAWS Nitinol Staple System | Paragon 28, Inc. | May 11, 2023 | SESE |
| K223056 | JAWS Nitinol Staple System | Paragon 28, Inc. | Feb 16, 2023 | SESE |
| K222645 | Treace Medical Concepts (TMC) Implant Fixation System | Treace Medical Concepts | Nov 21, 2022 | SESE |
| K221947 | Tyber Medical Staple Fixation System (various) | Tyber Medical, LLC | Oct 20, 2022 | SESE |
| K220812 | DynaClip® Bone Staple | MedShape, Inc. | Aug 19, 2022 | SESE |
| K210582 | EasyClip® and EasyClip® Xpress | Stryker GmbH | Jun 10, 2022 | SESE |
| K220181 | StealthFix Intraosseous Fixation System | Nextremity Solutions, Inc. | Mar 22, 2022 | SESE |
| K203832 | FuseForce Flex Dynamic Compression System | Wright Medical | May 7, 2021 | SESE |
| K210482 | Medline UNITE REFLEX Nitinol Staple System | Medline Industries, Inc. | Apr 22, 2021 | SESE |
| K210456 | Ligament Staple | Medacta International S.A. | Apr 12, 2021 | SESE |
| K203180 | Arthrex DynaNite Nitinol Staples | Arthrex, Inc. | Dec 16, 2020 | SESE |
| K193305 | DynaClip Bone Staple | MedShape, Inc. | Apr 23, 2020 | SESE |
| K192447 | Superelastic Staple | Neosteo | Feb 28, 2020 | SESE |
| K191463 | DePuy Synthes Hammertoe Continuous Compression Implant | Synthes (USA) Products, LLC | Feb 26, 2020 | SESE |
| K191636 | APTUS Foot System | Medartis AG | Aug 16, 2019 | SESE |
| K190722 | TriMAX Implant System | Crossroads Extemity Systems, LLC | Aug 16, 2019 | SESE |
| K190166 | TriMed Nitinol Staple System | TriMed, Inc. | Jul 1, 2019 | SESE |
| K182943 | VERTEX Nitinol Staple System | Nvision Biomedical Technologies, LLC | Apr 4, 2019 | SESE |
| K182212 | Geo Staple System | Gramercy Extremity Orthopedics, LLC | Jan 11, 2019 | SESE |
| K181781 | DynaClipTM Bone Staple | MedShape, Inc. | Nov 5, 2018 | SESE |
| K181815 | DynaBridge | Fusion Orthopedics, LLC | Oct 15, 2018 | SESE |
| K181866 | MotoCLIP/HiMAX Step Staple Implant System | Crossroads Extremity Systems, LLC | Aug 9, 2018 | SESE |
| K180544 | DePuy Synthes Static Staples | Synthes (USA) Products, LLC | Jul 24, 2018 | SESE |
| K181410 | MotoCLIP/HiMAX Implant System | Crossroads Extremity Systems, LLC | Jun 29, 2018 | SESE |
| K173775 | Clench Compression Staple | F & A Foundation, LLC D.B.A. Reign Medical | Apr 6, 2018 | SESE |
| K173693 | Orbitum Bone Staple Implant, X and VI | Orthovestments, LLC | Feb 23, 2018 | SESE |
| K172205 | ExoToe Staple | Exotoe, LLC | Jan 11, 2018 | SESE |
| K172052 | Arthrex DynaNite Nitinol Staple | Arthrex, Inc. | Dec 13, 2017 | SESE |
| K172405 | SNIPER STAPLE SYSTEM, NON-STERILE | Trilliant Surgical | Dec 11, 2017 | SESE |
| K171473 | Compressyn Staple | Dallen Medical, Inc. | Nov 7, 2017 | SESE |
| K170923 | JAWS(TM) Nitinol Staple System | Paragon 28 | Jul 24, 2017 | SESE |
| K163226 | EPIC Extremely Small Staple | Epic Extremely, LLC | May 16, 2017 | SESE |
| K162354 | Sniper Staple System | Trilliant Surgical, Ltd. | Apr 20, 2017 | SESE |
| K162321 | EasyClip Xpress | Restore Surgical, LLC Dba Instratek | Feb 10, 2017 | SESE |
| K163440 | Stealth Staple System | First Ray, LLC | Feb 1, 2017 | SESE |
| K161587 | Memodyn Staple | Austin & Associates, Inc./Telos Medical Equipment | Feb 1, 2017 | SESE |
| K161426 | NeoSpan Compression Staple Impant w/instruments | In2bones USA, LLC | Oct 24, 2016 | SESE |
| K160813 | EasyStep | Stryker GmbH | Jul 26, 2016 | SESE |
| K153622 | First Ray Internal Bone Staple System | First Ray, LLC | Apr 8, 2016 | SESE |
| K153770 | OS2(R)-VP Varisation Staple | In2bones Sas | Mar 21, 2016 | SESE |
| K153395 | OS2-C Compression Staple | In2bones Sas | Feb 18, 2016 | SESE |
| K153129 | dynaMX Tabbed Staple | Mx Orthopedics, Corp. | Jan 28, 2016 | SESE |
| K151762 | PediatrOS RigidTack/FlexTack | Merete Medical GmbH | Dec 28, 2015 | SESE |
| K151615 | TiTHON Staple with OsseoTi Technology | Biomet Manufacturing Corp | Oct 2, 2015 | SESE |
| K151160 | Arcus Staple System | Nextremity Solutions, Inc. | Sep 4, 2015 | SESE |
| K143622 | dynaMX Compression Staple | Mx Orthopedics, Corp. | Jun 17, 2015 | SESE |
| K150125 | Elite Nitinol Fixation System | Biomedical Enterprises, Inc. | May 11, 2015 | SESE |
| K143323 | OS2-V Varisation Staple | In2bones Sas | Feb 26, 2015 | SESE |
| K143037 | SnapShot Fixation System | Biomet Manufacturing Corp | Jan 20, 2015 | SESE |
| K142111 | ARCAD COMPRESSIVE OSTEOSYNTHESIS STAPLE, EXPRESS COMPRESSIVE OSTEOSYNTHESIS STAPLE | Novatsep | Dec 19, 2014 | SESE |
| K141263 | TOGGLELOC AND JUGGERLOC IMPLANTS/INSTRUMENTS/KITS | Biomet Manufacturing Corp | Nov 19, 2014 | SESE |
| K142292 | Speed, Speed Shift, Speed Titan, Speed Arc | Biomedical Enterprises, Inc. | Nov 17, 2014 | SESE |
| K142727 | CrossCLIP Implant System | Orthodiscovery Group, LLC(D.B.A. Crossroads Extremity Systems | Oct 24, 2014 | SESE |
| K142148 | ORTHOHELIX STAPLE SYSTEM | Orthohelix Surgical Designs, Inc. | Aug 21, 2014 | SESE |
| K141550 | INSTAFIX SHAPE MEMORY FIXATION SYSTEM | Ot Medical | Jul 11, 2014 | SESE |
| K140358 | COMPRESSYN STAPLE | Dallen Medical, Inc. | Jun 2, 2014 | SESE |
| K133270 | SPEED ARC | Biomedical Enterprises, Inc. | Apr 17, 2014 | SESE |
| K133844 | SPEED TRIAD | Biomedical Ent., Inc. | Apr 7, 2014 | SESE |
| K133780 | SPEED XL | Biomedical Ent., Inc. | Mar 19, 2014 | SESE |
| K133523 | STAPIX SUPERELASTIC IMPLANT BONE STAPLES | Instratek, Inc. | Feb 6, 2014 | SESE |
| K132875 | COMPRESSYN STAPLE | Dallen Medical, Inc. | Dec 30, 2013 | SESE |
| K131061 | RESTORE BUNION CORRECTION SYSTEM | Nextremity Solutions | Aug 28, 2013 | SESE |
| K130832 | ORTHOHELIX STAPLE SYSTEM | Orthohelix Surgical Designs, Inc. | Aug 15, 2013 | SESE |
| K124045 | FUSEFORCE IMPLANT SYSTEM | Solana Surgical, LLC | Jul 10, 2013 | SESE |
| K124022 | SPEED SHIFT | Biomedical Enterprises, Inc. | May 14, 2013 | SESE |
| K123926 | METASURG NITINOL STAPLE IMPLANT | Metasurg | May 3, 2013 | SESE |
| K122113 | MEMORY METAL STAPLES, EASYCLIP | Stryker Corp. | Mar 12, 2013 | SESE |
| K122871 | COMPRESSYN STAPLE | Dallen Medical, Inc. | Feb 7, 2013 | SESE |
| K123363 | SUPER STAPLE(TM) CLASSIC | Metric Medical Devices, Inc. | Jan 3, 2013 | SESE |
| K112837 | VILEX EZ-STAPLE (MEMORY BONE FIXATION STAPLE) | Vilex, Inc. | Oct 9, 2012 | SESE |
| K102387 | MEDISCOPE COMPRESSIOPN STAPLE AND ACCESSORIES | Mediscope Manufacturing, Inc. | Oct 24, 2011 | SESE |
| K102143 | SUSPENSION ACROMIOCLAVICULAR (AC) REPAIR SYSTEM | Suspension Orthopaedic Solutions, LLC | Dec 8, 2010 | SESE |
| K102107 | OSSTAPLE CHILL | Biomedical Ent., Inc. | Sep 3, 2010 | SESE |
| K082215 | OSTEORAPTOR SUTURE ANCHOR | Smith & Nephew Inc., Endoscopy Division | Nov 3, 2008 | SESE |
| K081172 | COMPOSITE HITCH SUTURE ANCHOR | Biomet Manufacturing Corp | Jul 17, 2008 | SESE |
| K081098 | ENDOBUTTON CONTINUOUS LOOP (CL) | Smith & Nephew Inc., Endoscopy Division | Jul 16, 2008 | SESE |
| K073281 | CAIS STAPLE | Depuy Mitek, A Johnson & Johnson Company | May 2, 2008 | SESE |
| K080111 | ARTHREX COMPRESSION STAPLE | Arthrex, Inc. | Feb 13, 2008 | SESE |
| K072298 | BIOPRO MEMORY STAPLE, MODELS 18062-18073 | Biopro, Inc. | Oct 29, 2007 | SESE |
| K071477 | REVERTO 55 AND 37 SHAPE MEMORY STAPLES | Core Essence Orthopaedics, LLC | Aug 15, 2007 | SESE |
| K071637 | INTRINSIC THERAPEUTICS FIXATION STAPLE | Intrinsic Therapeutics Incorporated | Aug 3, 2007 | SESE |
| K071479 | SBI STAFIX | Small Bone Innovations, Inc. | Aug 2, 2007 | SESE |
| K071257 | MINI QUICKANCHOR AND QUICKANCHOR PLUS WITH ORTHOCORD | Depuy Mitek, A Johnson & Johnson Company | Jun 29, 2007 | SESE |
| K070688 | NEXFIX COMPRESSION STAPLE | Nexa Orthopedics, Inc. | May 18, 2007 | SESE |
| K070033 | MEMOMETAL VARISATION, MODELS AV26-08, AV26-10, AV90-08 AND AV90-10 | Memometal Technologies | Mar 19, 2007 | SESE |
| K070031 | MEMOMETAL MEMORY STAPLES | Memometal Technologies | Mar 19, 2007 | SESE |
| K063273 | PANALOK QUICKANCHOR PLUS, PANALOK RC QUICKANCHOR PLUS DUAL SUTURE, PANALOK ANCHOR | Depuy Miltek, A Johnson & Johnson Co. | Nov 22, 2006 | SESE |
| K062734 | ADJUST-RIGHT FIXATION DEVICES | Valpo Orthopedic Technology, Inc. | Nov 22, 2006 | SESE |
| K061776 | ARTHROTEK MAXFIRE MENISCAL REPAIR DEVICE | Arthrotek, Inc. | Sep 25, 2006 | SESE |
| K062170 | BIOKNOTLESS AND LUPINE PLUS ANCHORS | Depuy Mitek, A Johnson & Johnson Company | Aug 22, 2006 | SESE |
| K061798 | BIOPRO MEMORY STAPLE | Biopro, Inc. | Aug 21, 2006 | SESE |
| K061801 | 2.8 & 3.5MM LACTOSCREW SUTURE ANCHORS | Arthrotek, Inc. | Aug 7, 2006 | SESE |
| K061657 | HITCH LACTOSORB SUTURE ANCHOR | Arthrotek, Inc. | Jul 25, 2006 | SESE |
| K061389 | ALLTHREAD LACTOSORB SUTURE ANCHOR | Arthrotek, Inc. | Jul 19, 2006 | SESE |
| K060970 | AXYALOOP NONABSORBABLE BONE ANCHOR | Axya Medical, Inc. | Jul 5, 2006 | SESE |
| K061594 | LARGE UNI-CLIP STAPLE | New Deal, S.A. | Jul 3, 2006 | SESE |
| K060746 | MEMORY STAPLE | DePuy Orthopaedics, Inc. | May 25, 2006 | SESE |
| K060553 | RC LOOP /DUAL ORTHOCORD SUTURE,RC LOOP W/ETHIBOND SUTURE,RC LOOP W/PANACRYL SUTURE | Depuy Mitek, A Johnson & Johnson Company | May 4, 2006 | SESE |
| K060014 | INTELIFUSE, INC., WARMSYSTEM WITH STIMULINKS | Intelifuse, Inc. | Apr 3, 2006 | SESE |
| K052631 | SUPER QUICKANCHOR PLUS (WITH ORTHOCORD SUTURE) | Depuy Mitek, A Johnson & Johnson Company | Oct 21, 2005 | SESE |
| K051989 | GII QUICKANCHOR PLUS WITH ORTHOCORD SUTURE | Depuy Mitek, A Johnson & Johnson Company | Aug 5, 2005 | SESE |
| K051408 | INTELIFUSE, INC. WARM SYSTEM WITH STIMULINKS | Intelifuse, Inc. | Jun 29, 2005 | SESE |
| K043059 | COMPRESSION STAPLE AND SIMPLE STAPLE | Wrightmedicaltechnologyinc | Jan 18, 2005 | SESE |
| K041988 | ARTHROTEK MENISCAL HYBRID DEVICE | Biomet, Inc. | Oct 20, 2004 | SESE |
| K041117 | PANALOK RC QUICKANCHOR PLUS, MODEL 212130, 212730; DUAL SUTURE PANALOK RC QUICKANCHOR PLLUS, MODELS 212132, 212732 | Depuy Mitek | May 28, 2004 | SESE |
| K041116 | SUPER QUICKANCHOR PLUS | Depuy Mitek | May 28, 2004 | SESE |
| K041115 | GII QUICKANCHOR PLUS | Depuy Mitek, A Johnson & Johnson Company | May 28, 2004 | SESE |
| K041064 | BIOKNOTLESS RC ANCHOR | Depuy Mitek | May 13, 2004 | SESE |
| K041065 | PANALOK RC LOOP ANCHOR | Depuy Mitek | May 7, 2004 | SESE |
| K031127 | ORTHOPEDIC WIRE | Howmedica Osteonics Corp. | Apr 28, 2003 | SESE |
| K023388 | MITEK RAPIDLOC-PDS MENISCAL REPAIR SYSTEM | Mitek Worldwide | Dec 27, 2002 | SESE |
| K021953 | MITEK PDS/PGA STAPLE | Mitek Worldwide | Dec 20, 2002 | SESE |
| K023417 | SURETAC III, MODELS 7209900, 7209901 | Smith & Nephew, Inc. | Nov 7, 2002 | SESE |
| K023203 | OSSTAPLE | Biomedical Ent., Inc. | Oct 17, 2002 | SESE |
| K020948 | SMITH & NEPHEW SURETAC - EXPANDED INDICATIONS II | Smith & Nephew, Inc. | Oct 9, 2002 | SESE |
| K012081 | DYNAMIC COMPRESSION SHAPE MEMORY ALLOY (SMA) STAPLE SYSTEM | Medtronic Sofamor Danek, Inc. | Oct 1, 2001 | SESE |
| K011716 | THE UNI-CLIP STAPLE | New Deal, S.A. | Aug 30, 2001 | SESE |
| K010051 | POLY-TAPES WITH THE FASTLOK FIXATION DEVICE | Xiros Plc | Jul 13, 2001 | SESE |
| K002695 | MEMODYN STAPLE | Telos Medical Equipment | Jun 13, 2001 | SESE |
| K003033 | SCAPHIX, STAPLE, FIXATION, BONE | Avanta Orthopaedics, Inc. | May 30, 2001 | SESE |
| K001354 | MEMOGRAPH; OSSTAPLE - ORTHOPEDIC USES FOR SMALL BONE AND FRAGMENT FIXATION FOR THE MEMOGRAPH STAPLE SYSTEM | Biomedical Ent., Inc. | Mar 13, 2001 | SESE |
| K000797 | OBL 2.0 MM MINI TAC ANCHOR, MODEL 10-1629-01 | Orthopaedic Biosystems, Ltd. | Apr 3, 2000 | SESE |
| K993714 | MEMOGRAPH STAPLE, WARM SYSTEM | Biomedical Ent., Inc. | Feb 25, 2000 | SESE |
| K991962 | EIS DYNAMIC MEMORY STAPLES SYSTEM | Groupe Lepine | Jan 10, 2000 | SESE |
| K991566 | SOLUSTAPLE | New Deal, S.A. | Aug 3, 1999 | SESE |
| K991482 | UNI-CLIP STAPLE | New Deal, S.A. | Jun 3, 1999 | SESE |
| K982996 | POLYMER OBL SB ANCHOR / SUTURE COMBINATION | Orthopaedic Biosystems, Ltd. | Mar 4, 1999 | SESE |
| K982420 | MITEK MICRO ANCHOR | Mitek Products | Aug 24, 1998 | SESE |
| K981798 | LACTOSORB POP RIVET | Biomet, Inc. | Jul 13, 1998 | SESE |
| K964226 | MEMORY STAPLE (20 SIZES AVAILABLE) | Landos, Inc. | Aug 5, 1997 | SESE |
| K965175 | HOWMEDICA MAINSTAY ANCHOR | Howmedica Corp. | Mar 13, 1997 | SESE |
| K962793 | MITEK MICRO ANCHOR | Mitek Products | Oct 1, 1996 | SESE |
| K962705 | MLI MODULAR STAPLE | Medicinelodge, Inc. | Oct 1, 1996 | SESE |
| K961585 | SURGICAL DYNAMICS POP RIVET | United States Surgical, A Division of Tyco Healthc | Jul 10, 1996 | SESE |
| K961578 | SUTURE ANCHOR | United States Surgical, A Division of Tyco Healthc | Jul 10, 1996 | SESE |
| K961555 | ACUFEX TAG BIOABSORBABLE ANCHORS | Acufex Microsurgical, Inc. | Jul 10, 1996 | SESE |
| K954443 | LACTOSORB SUTURE ANCHOR | Poly-Medics,Inc. | Jan 31, 1996 | SN |
| K950272 | PANALOK ABSORBABLE SUTURE ANCHOR SYSTEM | ETHICON, Inc. | Jan 18, 1996 | SN |
| K953276 | ACUFEX TAG DELIVERY SYSTEM | Acufex Microsurgical, Inc. | Oct 5, 1995 | SESE |
| K953531 | HOWMEDICA MAINSTAY ANCHOR | Howmedica Corp. | Sep 26, 1995 | SN |
| K953764 | LMT BONE ANCHOR | Li Medical Technologies, Inc. | Aug 25, 1995 | SESE |
| K942889 | SB ANCHOR | Orthopaedic Biosystems, Ltd. | Aug 25, 1995 | SESE |
| K952348 | OGDEN ANCHOR | American Medical Electronics, Inc. | Aug 21, 1995 | SESE |
| K941772 | CRADLE FIXATION DEVICE | Neoligaments, Ltd. | Aug 7, 1995 | SESE |
| K951658 | LACTOSORB POP RIVET | Poly-Medics,Inc. | Jul 25, 1995 | SN |
| K943950 | ETHICON NONABSORBABLE SUTURE ANCHOR | ETHICON, Inc. | May 30, 1995 | SN |
| K950070 | MITEK TOGGLE ANCHOR(TM) | Mitek Surgical Products, Inc. | May 22, 1995 | SESE |
| K946346 | ACUFEX TAG(R) BIOABSORBABLE ANCHORS | Acufex Microsurgical, Inc. | Apr 26, 1995 | SESE |
| K944936 | MITEK G III ANCHOR, MITEK LS ANCHOR | Mitek Surgical Products, Inc. | Mar 24, 1995 | SESE |
| K943548 | BIOABSORBABLE INTERFERENCE SCREW | Acufex Microsurgical, Inc. | Mar 20, 1995 | SESE |
| K945203 | MITEK THRADED ANCHOR (MTA) | Mitek Surgical Products, Inc. | Mar 6, 1995 | SESE |
| K941029 | OGDEN ANCHOR-SMALL (TENTATIVE) | American Medical Electronics, Inc. | Feb 9, 1995 | SESE |
| K934867 | ACUFEX TAG ANCHOR | Acufex Microsurgical, Inc. | Feb 9, 1995 | SESE |
| K943492 | ARTHREX STAPLES | Arthrex, Inc. | Feb 1, 1995 | SN |
| K935065 | OGDEN ANCHOR ADDITIONAL APPLICATIONS | American Medical Electronics, Inc. | Jan 30, 1995 | SESE |
| K942787 | BONE ANCHOR | Acu Med, Inc. | Dec 15, 1994 | SESE |
| K935321 | INNOVASIVE SUTURE BONE FASTENER WITH SUTURE | Innovasive Devices, Inc. | Oct 19, 1994 | SESE |
| K932041 | XANCHOR SUTURE ATTACHMENT DEVICE | Orthopaedic Biosystems | Aug 12, 1994 | SN |
| K931782 | MITEK GIII ANCHOR | Mitek Surgical Products, Inc. | Jul 22, 1994 | SN |
| K935167 | OGDEN ANCHOR (MODIFICATION) | American Medical Electronics, Inc. | Jul 12, 1994 | SN |
| K931519 | ACUFEX SURETAC | Acufex Microsurgical, Inc. | Jun 16, 1994 | SESE |
| K931253 | QUICKANCHOR II | Mitek Surgical Products, Inc. | Jun 16, 1994 | SESE |
| K932925 | BONE ANCHOR FOR SOFT TISSUE ATTACHMENT | Vesitec Medical, Inc. | Apr 26, 1994 | SESE |
| K930967 | BAUMER STAPLES | Baumer Ortopedia , Ltd. | Mar 7, 1994 | SESE |
| K930892 | MITEK MINI ANCHOR, MODIFICATION | Mitek Surgical Products, Inc. | Jan 7, 1994 | SESE |
| K930893 | MITEK SUPER QUICKANCHOR, MODIFICATION | Mitek Surgical Products, Inc. | Dec 8, 1993 | SESE |
| K926384 | STATAK & MINI-STATAK SOFT TISSUE ATTACHMENT DEVICE | Zimmer, Inc. | Nov 16, 1993 | SESE |
| K926270 | MITEK LIGAMENT ANCHOR | Mitek Surgical Products, Inc. | Oct 22, 1993 | SESE |
| K930538 | ACUFEX SURETAC(R) PAC | Acufex Microsurgical, Inc. | Sep 13, 1993 | SESE |
| K924034 | MINVASIVE SUTURE BONE FASTENER | Innovasive Devices, Inc. | Aug 24, 1993 | SESE |
| K924367 | OGDEN ANCHOR | Advanced Surgical Implants, Inc. | Jul 26, 1993 | SESE |
| K911293 | ACUFEX(R) TAG(TM) | Acufex Microsurgical, Inc. | Jul 21, 1993 | SESE |
| K931182 | VESITEC DRILL GUIDE | Vesitec Medical, Inc. | Jun 9, 1993 | SESE |
| K924941 | CONCEPT 4MM CANCELLOUS SCREW WITH EYELET | Linvatec Corp. | Jun 4, 1993 | SESE |
| K926037 | HARPOON SUTURE ANCHOR | Biomet, Inc. | May 5, 1993 | SESE |
| K924665 | QUICKANCHOR | Mitek Surgical Products, Inc. | Oct 27, 1992 | SESE |
| K915889 | MITEK BONE ANCHOR, MODIFICATION | Mitek Surgical Products, Inc. | Oct 22, 1992 | SESE |
| K921873 | QUICKANCHOR, MODIFICATION | Mitek Surgical Products, Inc. | Jun 9, 1992 | SESE |
| K920213 | MITEK ANCHOR, MITEK ANCHOR II | Mitek Surgical Products, Inc. | May 1, 1992 | SESE |
| K911837 | SURETAC POLYGLYCONATE ABSORBABLE FIXATION DEVICE | Acufex Microsurgical, Inc. | Nov 15, 1991 | SESE |
| K913461 | FASTLOK (STAPLE & BUCKLE) FIXATION SYSTEM | Neoligaments, Ltd. | Oct 15, 1991 | SESE |
| K911445 | FASTLOK (STAPLE AND BUCKLE) FIXATION SYSTEM | Neoligaments, Ltd. | Jun 28, 1991 | SESE |
| K911031 | THE TRAMOND PIN | Sport Service, Inc. | May 29, 1991 | SESE |
| K911026 | STAPLE BLADE FOR TIBIAL OSTEO/STAPLE BLADE L'UNION | Sport Service, Inc. | May 29, 1991 | SESE |
| K911020 | LIGAMENTOPLASTIC STAPLE OF L'UNION | Sport Service, Inc. | May 29, 1991 | SESE |
| K910723 | BIODEGRADABLE SURGICAL STAPLE | Instrument Makar, Inc. | Mar 12, 1991 | SESE |
Top Applicants
- Mitek Surgical Products, Inc. — 16 clearances
- Acufex Microsurgical, Inc. — 9 clearances
- Depuy Mitek, A Johnson & Johnson Company — 7 clearances
- Biomedical Ent., Inc. — 6 clearances
- Howmedica Corp. — 5 clearances