Staple, Fixation, Bone
FDA product code JDR · Class II (moderate risk) · 21 CFR 888.3030 · Orthopedic
233510(k) clearances
0PMA approvals
35recalls
Implantimplanted device
Manufacturers
- Mitek Surgical Products, Inc. 16
- Acufex Microsurgical, Inc. 9
- Depuy Mitek, A Johnson & Johnson Company 7
- Biomedical Ent., Inc. 6
- Arthrex, Inc. 6
- Howmedica Corp. 5
- Dallen Medical, Inc. 4
- Medline Industries, LP 4
- Neoligaments, Ltd. 4
- American Medical Electronics, Inc. 4
- Treace Medical Concepts, Inc. 4
- New Deal, S.A. 4
- Depuy Mitek 4
- Orthopaedic Biosystems, Ltd. 4
- Biomedical Enterprises, Inc. 4
- Arthrotek, Inc. 4
- Biomet Manufacturing Corp 4
- Paragon 28, Inc. 4
- Stryker Corporation 3
- O'Tec Corp. 3
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262451 | Arthrex DynaNite StaplesJDR · Traditional | Arthrex, Inc. | 09/01/2026SE |
| K261121 | Megalodon Dynamic Compression SystemJDR · Traditional | Paragon 28, Inc. | 08/06/2026SE |
| K250712 | Linkt Compression Staple SystemJDR · Traditional | Trax Surgical | 05/14/2025SE |
| K243888 | Medline UNITE® REFLEX® Hybrid Nitinol Implant SystemJDR · Traditional | Medline Industries, LP | 04/11/2025SE |
| K243742 | Arthrex DynaNite Nitinol StaplesJDR · Traditional | Arthrex, Inc. | 01/31/2025SE |
| K243658 | TMC Compression Implant SystemJDR · Special | Treace Medical Concepts | 12/26/2024SE |
| K242415 | TMC Compression Implant SystemJDR · Special | Treace Medical Concepts | 09/06/2024SE |
| K240212 | COGNiTiON Staple SystemJDR · Special | Ortho Solutions UK , Ltd. | 02/23/2024SE |
| K232990 | ATOMIC Nitinol Fixation SystemJDR · Traditional | Rmr Ortho, LLC | 01/12/2024SE |
| K230724 | arcad® 2.0 Duo & Quadro osteosynthesis compressive staplesJDR · Traditional | Novastep | 12/04/2023SE |
| K232905 | Medline UNITE® REFLEX® Nitinol Staple KitJDR · Special | Medline Industries, LP | 10/19/2023SE |
| K232324 | StealthFix Intraosseous Fixation SystemJDR · Special | Medartis, Inc. | 08/30/2023SE |
| K232387 | Treace Medical Concepts (TMC) Compression Implant SystemJDR · Special | Treace Medical Concepts | 08/28/2023SE |
| K231493 | NITINEX Memory Compression StapleJDR · Traditional | Vilex, LLC | 08/11/2023SE |
| K231885 | Medline UNITE® REFLEX® Nitinol Staple SystemJDR · Traditional | Medline Industries, LP | 08/09/2023SE |
| K231458 | Extremity StapleJDR · Traditional | Restor3D | 08/03/2023SE |
| K230550 | JAWS Nitinol Staple SystemJDR · Traditional | Paragon 28, Inc. | 05/11/2023SE |
| K223056 | JAWS Nitinol Staple SystemJDR · Traditional | Paragon 28, Inc. | 02/16/2023SE |
| K222645 | Treace Medical Concepts (TMC) Implant Fixation SystemJDR · Traditional | Treace Medical Concepts | 11/21/2022SE |
| K221947 | Tyber Medical Staple Fixation System (various)JDR · Traditional | Tyber Medical, LLC | 10/20/2022SE |
| K220812 | DynaClip® Bone StapleJDR · Traditional | MedShape, Inc. | 08/19/2022SE |
| K210582 | EasyClip® and EasyClip® XpressJDR · Traditional | Stryker GmbH | 06/10/2022SE |
| K220181 | StealthFix Intraosseous Fixation SystemJDR · Traditional | Nextremity Solutions, Inc. | 03/22/2022SE |
| K203832 | FuseForce Flex Dynamic Compression SystemJDR · Traditional | Wright Medical | 05/07/2021SE |
| K210482 | Medline UNITE REFLEX Nitinol Staple SystemJDR · Traditional | Medline Industries, Inc. | 04/22/2021SE |
| K210456 | Ligament StapleJDR · Traditional | Medacta International S.A. | 04/12/2021SE |
| K203180 | Arthrex DynaNite Nitinol StaplesJDR · Traditional | Arthrex, Inc. | 12/16/2020SE |
| K193305 | DynaClip Bone StapleJDR · Traditional | MedShape, Inc. | 04/23/2020SE |
| K192447 | Superelastic StapleJDR · Traditional | Neosteo | 02/28/2020SE |
| K191463 | DePuy Synthes Hammertoe Continuous Compression ImplantJDR · Traditional | Synthes (USA) Products, LLC | 02/26/2020SE |
| K191636 | APTUS Foot SystemJDR · Traditional | Medartis AG | 08/16/2019SE |
| K190722 | TriMAX Implant SystemJDR · Traditional | Crossroads Extemity Systems, LLC | 08/16/2019SE |
| K190166 | TriMed Nitinol Staple SystemJDR · Traditional | TriMed, Inc. | 07/01/2019SE |
| K182943 | VERTEX Nitinol Staple SystemJDR · Traditional | Nvision Biomedical Technologies, LLC | 04/04/2019SE |
| K182212 | Geo Staple SystemJDR · Traditional | Gramercy Extremity Orthopedics, LLC | 01/11/2019SE |
| K181781 | DynaClipTM Bone StapleJDR · Traditional | MedShape, Inc. | 11/05/2018SE |
| K181815 | DynaBridgeJDR · Traditional | Fusion Orthopedics, LLC | 10/15/2018SE |
| K181866 | MotoCLIP/HiMAX Step Staple Implant SystemJDR · Special | Crossroads Extremity Systems, LLC | 08/09/2018SE |
| K180544 | DePuy Synthes Static StaplesJDR · Traditional | Synthes (USA) Products, LLC | 07/24/2018SE |
| K181410 | MotoCLIP/HiMAX Implant SystemJDR · Special | Crossroads Extremity Systems, LLC | 06/29/2018SE |
| K173775 | Clench Compression StapleJDR · Traditional | F & A Foundation, LLC D.B.A. Reign Medical | 04/06/2018SE |
| K173693 | Orbitum Bone Staple Implant, X and VIJDR · Traditional | Orthovestments, LLC | 02/23/2018SE |
| K172205 | ExoToe StapleJDR · Traditional | Exotoe, LLC | 01/11/2018SE |
| K172052 | Arthrex DynaNite Nitinol StapleJDR · Traditional | Arthrex, Inc. | 12/13/2017SE |
| K172405 | Sniper Staple System, Non-SterileJDR · Traditional | Trilliant Surgical | 12/11/2017SE |
| K171473 | Compressyn StapleJDR · Traditional | Dallen Medical, Inc. | 11/07/2017SE |
| K170923 | JAWS(TM) Nitinol Staple SystemJDR · Traditional | Paragon 28 | 07/24/2017SE |
| K163226 | EPIC Extremely Small StapleJDR · Traditional | Epic Extremely, LLC | 05/16/2017SE |
| K162354 | Sniper Staple SystemJDR · Traditional | Trilliant Surgical, Ltd. | 04/20/2017SE |
| K162321 | EasyClip XpressJDR · Traditional | Restore Surgical, LLC Dba Instratek | 02/10/2017SE |
| K163440 | Stealth Staple SystemJDR · Traditional | First Ray, LLC | 02/01/2017SE |
| K161587 | Memodyn StapleJDR · Special | Austin & Associates, Inc./Telos Medical Equipment | 02/01/2017SE |
| K161426 | NeoSpan Compression Staple Impant w/instrumentsJDR · Traditional | In2bones USA, LLC | 10/24/2016SE |
| K160813 | EasyStepJDR · Traditional | Stryker GmbH | 07/26/2016SE |
| K153622 | First Ray Internal Bone Staple SystemJDR · Traditional | First Ray, LLC | 04/08/2016SE |
| K153770 | OS2(R)-VP Varisation StapleJDR · Traditional | In2bones Sas | 03/21/2016SE |
| K153395 | OS2-C Compression StapleJDR · Traditional | In2bones Sas | 02/18/2016SE |
| K153129 | dynaMX Tabbed StapleJDR · Traditional | Mx Orthopedics, Corp. | 01/28/2016SE |
| K151762 | PediatrOS RigidTack/FlexTackJDR · Traditional | Merete Medical GmbH | 12/28/2015SE |
| K151615 | TiTHON Staple with OsseoTi TechnologyJDR · Traditional | Biomet Manufacturing Corp | 10/02/2015SE |
| K151160 | Arcus Staple SystemJDR · Traditional | Nextremity Solutions, Inc. | 09/04/2015SE |
| K143622 | dynaMX Compression StapleJDR · Traditional | Mx Orthopedics, Corp. | 06/17/2015SE |
| K150125 | Elite Nitinol Fixation SystemJDR · Traditional | Biomedical Enterprises, Inc. | 05/11/2015SE |
| K143323 | OS2-V Varisation StapleJDR · Traditional | In2bones Sas | 02/26/2015SE |
| K143037 | SnapShot Fixation SystemJDR · Traditional | Biomet Manufacturing Corp | 01/20/2015SE |
| K142111 | Arcad Compressive Osteosynthesis Staple, Express Compressive Osteosynthesis StapleJDR · Traditional | Novatsep | 12/19/2014SE |
| K141263 | Toggleloc and Juggerloc Implants/Instruments/KitsJDR · Traditional | Biomet Manufacturing Corp | 11/19/2014SE |
| K142292 | Speed, Speed Shift, Speed Titan, Speed ArcJDR · Traditional | Biomedical Enterprises, Inc. | 11/17/2014SE |
| K142727 | CrossCLIP Implant SystemJDR · Traditional | Orthodiscovery Group, LLC(D.B.A. Crossroads… | 10/24/2014SE |
| K142148 | Orthohelix Staple SystemJDR · Special | Orthohelix Surgical Designs, Inc. | 08/21/2014SE |
| K141550 | Instafix Shape Memory Fixation SystemJDR · Special | Ot Medical | 07/11/2014SE |
| K140358 | Compressyn StapleJDR · Traditional | Dallen Medical, Inc. | 06/02/2014SE |
| K133270 | Speed ArcJDR · Traditional | Biomedical Enterprises, Inc. | 04/17/2014SE |
| K133844 | Speed TriadJDR · Special | Biomedical Ent., Inc. | 04/07/2014SE |
| K133780 | Speed XLJDR · Traditional | Biomedical Ent., Inc. | 03/19/2014SE |
| K133523 | Stapix Superelastic Implant Bone StaplesJDR · Traditional | Instratek, Inc. | 02/06/2014SE |
| K132875 | Compressyn StapleJDR · Traditional | Dallen Medical, Inc. | 12/30/2013SE |
| K131061 | Restore Bunion Correction SystemJDR · Traditional | Nextremity Solutions | 08/28/2013SE |
| K130832 | Orthohelix Staple SystemJDR · Traditional | Orthohelix Surgical Designs, Inc. | 08/15/2013SE |
| K124045 | Fuseforce Implant SystemJDR · Traditional | Solana Surgical, LLC | 07/10/2013SE |
| K124022 | Speed ShiftJDR · Traditional | Biomedical Enterprises, Inc. | 05/14/2013SE |
| K123926 | Metasurg Nitinol Staple ImplantJDR · Traditional | Metasurg | 05/03/2013SE |
| K122113 | Memory Metal Staples, EasyclipJDR · Traditional | Stryker Corp. | 03/12/2013SE |
| K122871 | Compressyn StapleJDR · Traditional | Dallen Medical, Inc. | 02/07/2013SE |
| K123363 | Super Staple(Tm) ClassicJDR · Traditional | Metric Medical Devices, Inc. | 01/03/2013SE |
| K112837 | Vilex Ez-Staple (Memory Bone Fixation Staple)JDR · Traditional | Vilex, Inc. | 10/09/2012SE |
| K102387 | Mediscope Compressiopn Staple and AccessoriesJDR · Traditional | Mediscope Manufacturing, Inc. | 10/24/2011SE |
| K102143 | Suspension Acromioclavicular (Ac) Repair SystemJDR · Traditional | Suspension Orthopaedic Solutions, LLC | 12/08/2010SE |
| K102107 | Osstaple ChillJDR · Special | Biomedical Ent., Inc. | 09/03/2010SE |
| K082215 | Osteoraptor Suture AnchorJDR · Traditional | Smith & Nephew Inc., Endoscopy Division | 11/03/2008SE |
| K081172 | Composite Hitch Suture AnchorJDR · Traditional | Biomet Manufacturing Corp | 07/17/2008SE |
| K081098 | Endobutton Continuous Loop (CL)JDR · Traditional | Smith & Nephew Inc., Endoscopy Division | 07/16/2008SE |
| K073281 | Cais StapleJDR · Traditional | Depuy Mitek, A Johnson & Johnson Company | 05/02/2008SE |
| K080111 | Arthrex Compression StapleJDR · Traditional | Arthrex, Inc. | 02/13/2008SE |
| K072298 | Biopro Memory Staple, Models 18062-18073JDR · Traditional | Biopro, Inc. | 10/29/2007SE |
| K071477 | Reverto 55 and 37 Shape Memory StaplesJDR · Traditional | Core Essence Orthopaedics, LLC | 08/15/2007SE |
| K071637 | Intrinsic Therapeutics Fixation StapleJDR · Traditional | Intrinsic Therapeutics Incorporated | 08/03/2007SE |
| K071479 | Sbi StafixJDR · Traditional | Small Bone Innovations, Inc. | 08/02/2007SE |
| K071257 | Mini Quickanchor and Quickanchor Plus with OrthocordJDR · Traditional | Depuy Mitek, A Johnson & Johnson Company | 06/29/2007SE |
| K070688 | Nexfix Compression StapleJDR · Traditional | Nexa Orthopedics, Inc. | 05/18/2007SE |
| K070033 | Memometal Varisation, Models AV26-08, AV26-10, AV90-08 and AV90-10JDR · Traditional | Memometal Technologies | 03/19/2007SE |
| K070031 | Memometal Memory StaplesJDR · Traditional | Memometal Technologies | 03/19/2007SE |
| K063273 | Panalok Quickanchor Plus, Panalok RC Quickanchor Plus Dual Suture, Panalok AnchorJDR · Special | Depuy Miltek, A Johnson & Johnson Co. | 11/22/2006SE |
| K062734 | Adjust-Right Fixation DevicesJDR · Traditional | Valpo Orthopedic Technology, Inc. | 11/22/2006SE |
| K061776 | Arthrotek Maxfire Meniscal Repair DeviceJDR · Traditional | Arthrotek, Inc. | 09/25/2006SE |
| K062170 | Bioknotless and Lupine Plus AnchorsJDR · Special | Depuy Mitek, A Johnson & Johnson Company | 08/22/2006SE |
| K061798 | Biopro Memory StapleJDR · Traditional | Biopro, Inc. | 08/21/2006SE |
| K061801 | 2.8 & 3.5MM Lactoscrew Suture AnchorsJDR · Traditional | Arthrotek, Inc. | 08/07/2006SE |
| K061657 | Hitch Lactosorb Suture AnchorJDR · Traditional | Arthrotek, Inc. | 07/25/2006SE |
| K061389 | Allthread Lactosorb Suture AnchorJDR · Traditional | Arthrotek, Inc. | 07/19/2006SE |
| K060970 | Axyaloop Nonabsorbable Bone AnchorJDR · Traditional | Axya Medical, Inc. | 07/05/2006SE |
| K061594 | Large Uni-Clip StapleJDR · Special | New Deal, S.A. | 07/03/2006SE |
| K060746 | Memory StapleJDR · Traditional | DePuy Orthopaedics, Inc. | 05/25/2006SE |
| K060553 | RC Loop /Dual Orthocord Suture,Rc Loop W/Ethibond Suture,Rc Loop W/Panacryl SutureJDR · Special | Depuy Mitek, A Johnson & Johnson Company | 05/04/2006SE |
| K060014 | Intelifuse, Inc., Warmsystem with StimulinksJDR · Traditional | Intelifuse, Inc. | 04/03/2006SE |
| K052631 | Super Quickanchor Plus (with Orthocord Suture)JDR · Special | Depuy Mitek, A Johnson & Johnson Company | 10/21/2005SE |
| K051989 | Gii Quickanchor Plus with Orthocord SutureJDR · Special | Depuy Mitek, A Johnson & Johnson Company | 08/05/2005SE |
| K051408 | Intelifuse, Inc. Warm System with StimulinksJDR · Traditional | Intelifuse, Inc. | 06/29/2005SE |
| K043059 | Compression Staple and Simple StapleJDR · Traditional | Wrightmedicaltechnologyinc | 01/18/2005SE |
| K041988 | Arthrotek Meniscal Hybrid DeviceJDR · Traditional | Biomet, Inc. | 10/20/2004SE |
| K041117 | Panalok RC Quickanchor Plus, Model 212130, 212730; Dual Suture Panalok RC Quickanchor…JDR · Special | Depuy Mitek | 05/28/2004SE |
| K041116 | Super Quickanchor PlusJDR · Special | Depuy Mitek | 05/28/2004SE |
| K041115 | Gii Quickanchor PlusJDR · Special | Depuy Mitek, A Johnson & Johnson Company | 05/28/2004SE |
| K041064 | Bioknotless RC AnchorJDR · Special | Depuy Mitek | 05/13/2004SE |
| K041065 | Panalok RC Loop AnchorJDR · Special | Depuy Mitek | 05/07/2004SE |
| K031127 | Orthopedic WireJDR · Special | Howmedica Osteonics Corp. | 04/28/2003SE |
| K023388 | Mitek Rapidloc-Pds Meniscal Repair SystemJDR · Special | Mitek Worldwide | 12/27/2002SE |
| K021953 | Mitek Pds/Pga StapleJDR · Traditional | Mitek Worldwide | 12/20/2002SE |
| K023417 | Suretac III, Models 7209900, 7209901JDR · Special | Smith & Nephew, Inc. | 11/07/2002SE |
| K023203 | OsstapleJDR · Special | Biomedical Ent., Inc. | 10/17/2002SE |
| K020948 | Smith & Nephew Suretac - Expanded Indications IIJDR · Traditional | Smith & Nephew, Inc. | 10/09/2002SE |
| K012081 | Dynamic Compression Shape Memory Alloy (Sma) Staple SystemJDR · Traditional | Medtronic Sofamor Danek, Inc. | 10/01/2001SE |
| K011716 | The Uni-Clip StapleJDR · Traditional | New Deal, S.A. | 08/30/2001SE |
| K010051 | Poly-Tapes with the Fastlok Fixation DeviceJDR · Traditional | Xiros Plc | 07/13/2001SE |
| K002695 | Memodyn StapleJDR · Traditional | Telos Medical Equipment | 06/13/2001SE |
| K003033 | Scaphix, Staple, Fixation, BoneJDR · Traditional | Avanta Orthopaedics, Inc. | 05/30/2001SE |
| K001354 | Memograph; Osstaple - Orthopedic Uses for Small Bone and Fragment Fixation for the…JDR · Traditional | Biomedical Ent., Inc. | 03/13/2001SE |
| K000797 | Obl 2.0 MM Mini Tac Anchor, Model 10-1629-01JDR · Special | Orthopaedic Biosystems, Ltd. | 04/03/2000SE |
| K993714 | Memograph Staple, Warm SystemJDR · Traditional | Biomedical Ent., Inc. | 02/25/2000SE |
| K991962 | Eis Dynamic Memory Staples SystemJDR · Traditional | Groupe Lepine | 01/10/2000SE |
| K991566 | SolustapleJDR · Traditional | New Deal, S.A. | 08/03/1999SE |
| K991482 | Uni-Clip StapleJDR · Traditional | New Deal, S.A. | 06/03/1999SE |
| K982996 | Polymer Obl SB Anchor / Suture CombinationJDR · Traditional | Orthopaedic Biosystems, Ltd. | 03/04/1999SE |
| K982420 | Mitek Micro AnchorJDR · Traditional | Mitek Products | 08/24/1998SE |
| K981798 | Lactosorb Pop RivetJDR · Traditional | Biomet, Inc. | 07/13/1998SE |
| K964226 | Memory Staple (20 Sizes Available)JDR · Traditional | Landos, Inc. | 08/05/1997SE |
| K965175 | Howmedica Mainstay AnchorJDR · Traditional | Howmedica Corp. | 03/13/1997SE |
| K962793 | Mitek Micro AnchorJDR · Traditional | Mitek Products | 10/01/1996SE |
| K962705 | Mli Modular StapleJDR · Traditional | Medicinelodge, Inc. | 10/01/1996SE |
| K961585 | Surgical Dynamics Pop RivetJDR · Traditional | United States Surgical, A Division of Tyco Healthc | 07/10/1996SE |
| K961578 | Suture AnchorJDR · Traditional | United States Surgical, A Division of Tyco Healthc | 07/10/1996SE |
| K961555 | Acufex Tag Bioabsorbable AnchorsJDR · Traditional | Acufex Microsurgical, Inc. | 07/10/1996SE |
| K954443 | Lactosorb Suture AnchorJDR · Traditional | Poly-Medics,Inc. | 01/31/1996SN |
| K950272 | Panalok Absorbable Suture Anchor SystemJDR · Traditional | ETHICON, Inc. | 01/18/1996SN |
| K953276 | Acufex Tag Delivery SystemJDR · Traditional | Acufex Microsurgical, Inc. | 10/05/1995SE |
| K953531 | Howmedica Mainstay AnchorJDR · Traditional | Howmedica Corp. | 09/26/1995SN |
| K953764 | LMT Bone AnchorJDR · Traditional | Li Medical Technologies, Inc. | 08/25/1995SE |
| K942889 | SB AnchorJDR · Traditional | Orthopaedic Biosystems, Ltd. | 08/25/1995SE |
| K952348 | Ogden AnchorJDR · Traditional | American Medical Electronics, Inc. | 08/21/1995SE |
| K941772 | Cradle Fixation DeviceJDR · Traditional | Neoligaments, Ltd. | 08/07/1995SE |
| K951658 | Lactosorb Pop RivetJDR · Traditional | Poly-Medics,Inc. | 07/25/1995SN |
| K943950 | Ethicon Nonabsorbable Suture AnchorJDR · Traditional | ETHICON, Inc. | 05/30/1995SN |
| K950070 | Mitek Toggle Anchor(Tm)JDR · Traditional | Mitek Surgical Products, Inc. | 05/22/1995SE |
| K946346 | Acufex Tag(R) Bioabsorbable AnchorsJDR · Traditional | Acufex Microsurgical, Inc. | 04/26/1995SE |
| K944936 | Mitek G III Anchor, Mitek LS AnchorJDR · Traditional | Mitek Surgical Products, Inc. | 03/24/1995SE |
| K943548 | Bioabsorbable Interference ScrewJDR · Traditional | Acufex Microsurgical, Inc. | 03/20/1995SE |
| K945203 | Mitek Thraded Anchor (Mta)JDR · Traditional | Mitek Surgical Products, Inc. | 03/06/1995SE |
| K941029 | Ogden Anchor-Small (Tentative)JDR · Traditional | American Medical Electronics, Inc. | 02/09/1995SE |
| K934867 | Acufex Tag AnchorJDR · Traditional | Acufex Microsurgical, Inc. | 02/09/1995SE |
| K943492 | Arthrex StaplesJDR · Traditional | Arthrex, Inc. | 02/01/1995SN |
| K935065 | Ogden Anchor Additional ApplicationsJDR · Traditional | American Medical Electronics, Inc. | 01/30/1995SE |
| K942787 | Bone AnchorJDR · Traditional | Acu Med, Inc. | 12/15/1994SE |
| K935321 | Innovasive Suture Bone Fastener with SutureJDR · Traditional | Innovasive Devices, Inc. | 10/19/1994SE |
| K932041 | Xanchor Suture Attachment DeviceJDR · Traditional | Orthopaedic Biosystems | 08/12/1994SN |
| K931782 | Mitek Giii AnchorJDR · Traditional | Mitek Surgical Products, Inc. | 07/22/1994SN |
| K935167 | Ogden Anchor (Modification)JDR · Traditional | American Medical Electronics, Inc. | 07/12/1994SN |
| K931519 | Acufex SuretacJDR · Traditional | Acufex Microsurgical, Inc. | 06/16/1994SE |
| K931253 | Quickanchor IIJDR · Traditional | Mitek Surgical Products, Inc. | 06/16/1994SE |
| K932925 | Bone Anchor for Soft Tissue AttachmentJDR · Traditional | Vesitec Medical, Inc. | 04/26/1994SE |
| K930967 | Baumer StaplesJDR · Traditional | Baumer Ortopedia , Ltd. | 03/07/1994SE |
| K930892 | Mitek Mini Anchor, ModificationJDR · Traditional | Mitek Surgical Products, Inc. | 01/07/1994SE |
| K930893 | Mitek Super Quickanchor, ModificationJDR · Traditional | Mitek Surgical Products, Inc. | 12/08/1993SE |
| K926384 | Statak & Mini-Statak Soft Tissue Attachment DeviceJDR · Traditional | Zimmer, Inc. | 11/16/1993SE |
| K926270 | Mitek Ligament AnchorJDR · Traditional | Mitek Surgical Products, Inc. | 10/22/1993SE |
| K930538 | Acufex Suretac(R) PacJDR · Traditional | Acufex Microsurgical, Inc. | 09/13/1993SE |
| K924034 | Minvasive Suture Bone FastenerJDR · Traditional | Innovasive Devices, Inc. | 08/24/1993SE |
| K924367 | Ogden AnchorJDR · Traditional | Advanced Surgical Implants, Inc. | 07/26/1993SE |
| K911293 | Acufex(R) Tag(Tm)JDR · Traditional | Acufex Microsurgical, Inc. | 07/21/1993SE |
| K931182 | Vesitec Drill GuideJDR · Traditional | Vesitec Medical, Inc. | 06/09/1993SE |
| K924941 | Concept 4MM Cancellous Screw with EyeletJDR · Traditional | Linvatec Corp. | 06/04/1993SE |
| K926037 | Harpoon Suture AnchorJDR · Traditional | Biomet, Inc. | 05/05/1993SE |
| K924665 | QuickanchorJDR · Traditional | Mitek Surgical Products, Inc. | 10/27/1992SE |
| K915889 | Mitek Bone Anchor, ModificationJDR · Traditional | Mitek Surgical Products, Inc. | 10/22/1992SE |
| K921873 | Quickanchor, ModificationJDR · Traditional | Mitek Surgical Products, Inc. | 06/09/1992SE |
| K920213 | Mitek Anchor, Mitek Anchor IIJDR · Traditional | Mitek Surgical Products, Inc. | 05/01/1992SE |
| K911837 | Suretac Polyglyconate Absorbable Fixation DeviceJDR · Traditional | Acufex Microsurgical, Inc. | 11/15/1991SE |
| K913461 | Fastlok (Staple & Buckle) Fixation SystemJDR · Traditional | Neoligaments, Ltd. | 10/15/1991SE |
| K911445 | Fastlok (Staple and Buckle) Fixation SystemJDR · Traditional | Neoligaments, Ltd. | 06/28/1991SE |
| K911031 | The Tramond PinJDR · Traditional | Sport Service, Inc. | 05/29/1991SE |
| K911026 | Staple Blade for Tibial Osteo/Staple Blade L'UnionJDR · Traditional | Sport Service, Inc. | 05/29/1991SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-3211-2026 | Reign Medical Clench Staple System (Compression), Description/REF: 9mm x 7mm/152-30907…Bone fixation staple requires a new 510(k); the performance characteristics of this device have not been… | F & A Foundation | 07/15/2026Open, Classified |
| Z-2355-2026 Class II | NeoSpan SuperElastic Compression Staple w/Instruments Catalog Number and Product Name…Due to the Magnetic Resonance Conditional Symbol missing on the carton, inner tray, and patient label. | In2bones USA, LLC | 05/11/2026Open, Classified |
| Z-0101-2023 Class II | DePuy Synthes Hammertoe Continuous Compression Implants, Product No. 46.239.001The subject products are being recalled because they contain the incorrect size drill guide and will not… | Synthes (USA) Products LLC | 09/27/2022Open, Classified |
| Z-0100-2023 Class II | SPEED 9X10X10mm Continuous Compression Implant, Product No. SE-0910The subject products are being recalled because they contain the incorrect size drill guide and will not… | Synthes (USA) Products LLC | 09/27/2022Open, Classified |
| Z-0099-2023 Class II | SPEED 15X12X12mm Continuous Compression Implant, Product No. SE-1512The subject products are being recalled because they contain the incorrect size drill guide and will not… | Synthes (USA) Products LLC | 09/27/2022Open, Classified |
| Z-0098-2023 Class II | SPEEDSHIFT20x20x20 Offset 10mm Implant Drill Kit, Product No. SE-2020-10. Used with…The subject products are being recalled because they contain the incorrect size drill guide and will not… | Synthes (USA) Products LLC | 09/27/2022Open, Classified |
| Z-0008-2023 Class II | Hammertoe Continuous Compression Implant (CCI) Kit Part Number: 46.239.001Drill Pin (drill bit) is not compatible with the Drill Template included in the kit due to a packaging… | Synthes (USA) Products LLC | 08/30/2022Open, Classified |
| Z-0853-2022 Class II | EasyFuse Dynamic Compression System Instrument PackThe drill and adjustable drill guide can jam/bind intraoperatively resulting in the drill guide breaking. | Wright Medical Technology, Inc. | 03/10/2022Terminated |
| Z-0812-2022 Class II | BIOMET TRAUMA Drill Bit, Tap, Guide Pin: [DVR Drill Bit, Item # 212000022, DVR 2.2MM…Packaging of various implants may not have sufficient adhesion on all sides, leading to loss of sterile… | Biomet, Inc. | 02/14/2022Terminated |
| Z-0811-2022 Class II | BIOMET TRAUMA A.L.P.S. FIBULA COMPOSITE LOCKING PLATE 8 HOLE, Item # 856204008. Devices…Packaging of various implants may not have sufficient adhesion on all sides, leading to loss of sterile… | Biomet, Inc. | 02/14/2022Terminated |
| Z-0810-2022 Class II | BIOMET Trauma, [Item # 13182-22-26, DVR CROSSLOCK EXTRA LONG PLATE LEFT], [Item #…Packaging of various implants may not have sufficient adhesion on all sides, leading to loss of sterile… | Biomet, Inc. | 02/14/2022Terminated |
| Z-0809-2022 Class II | BIOMET Sports Medicine JUGGERLOC SLOTTED REAMER: [Item # 110010371, 6MM], [Item…Packaging of various implants may not have sufficient adhesion on all sides, leading to loss of sterile… | Biomet, Inc. | 02/14/2022Terminated |
| Z-0650-2022 Class II | Merete PediatrOS RigidTack, REF CP20120, Size 20 mm, Sterile, Rx OnlyIncorrect marketing label (25 mm) was applied to product size 20 mm. | Merete Medical GmbH | 01/18/2022Terminated |
| Z-0457-2021 Class II | Osteosynthesis Compression Staple EasyClipThe device has the potential to release nickel above the acceptable margin of safety in pediatric patients… | Stryker GmbH | 09/25/2020Open, Classified |
| Z-0670-2019 Class II | NeoSpan SuperElastic Compression Staple w/Instruments, Size 10x10x10, Part Number T50…The NeoSpan Compression Staple (10x10x10) kits from two lots contain the wrong size drill bit. They contain… | In2bones USA, LLC | 11/14/2018Terminated |
| Z-2265-2018 Class II | Nitinol Staple, Elastic Staple Small-Symmetrical, Sterile R, Model #: a) ES-08x08; b)…During a retrospective review of sterilization records, TriMed has determined that evidence of quarterly… | TriMed Inc. | 04/13/2018Terminated |
| Z-2264-2018 Class II | Nitinol Staple, Elastic Staple Small-Asymmetrical, Sterile R, Model #: a) ES-10x13x15…During a retrospective review of sterilization records, TriMed has determined that evidence of quarterly… | TriMed Inc. | 04/13/2018Terminated |
| Z-2263-2018 Class II | Nitinol Staple, Elastic Staple Large-Symmetrical, Sterile R, Model #: a) ES-18x14; b)…During a retrospective review of sterilization records, TriMed has determined that evidence of quarterly… | TriMed Inc. | 04/13/2018Terminated |
| Z-2262-2018 Class II | Nitinol Staple, Elastic Staple Large-Asymmetrical, Sterile R, Model #: a) ES-18x15x17…During a retrospective review of sterilization records, TriMed has determined that evidence of quarterly… | TriMed Inc. | 04/13/2018Terminated |
| Z-2261-2018 Class II | P28 JAWS Nitinol Staple System kits are designed for use in an osteotomy, arthrodesis…Missing drill guide as stated in the package. | Paragon 28, Inc. | 12/19/2017Terminated |
| Z-1487-2017 Class II | MotoCLIP(TM) Super Elastic Fusion System, Size 18mm x 14mm x 14mm, REF 1442-1814, Rx…Seven 18mm x 18mm x 18 mm implants had been placed in kits, packed and labeled as 18mm x 14mm x 14mm. | Crossroads Extremity Systems Llc | 02/16/2017Terminated |
| Z-1410-2017 Class III | The UNI-CP System; Model Number: 330230SND.The firm received one complaint from one non-US sales representative (France) that the label on the UNI-CP… | Integra LifeSciences Corp. | 01/25/2017Terminated |
| Z-0855-2016 Class II | Stryker Vitallium Wire (6 Pack) Non Sterile. For use in bone procedures.The wire packages are correctly marked with a "NON-STERILE" label, however, the enclosed Instructions For… | Stryker Howmedica Osteonics Corp. | 12/23/2015Terminated |
| Z-1364-2015 Class II | Ziploop Button Product Usage: The Ziploop Button is a non-resorbable system intended to…The firm is recalling ToggleLocs and Ziploops manufactured in May and July of 2014 as they were not… | Biomet, Inc. | 02/26/2015Terminated |
| Z-1363-2015 Class II | ToggleLoc; fastener, fixation, non degradable, soft tissue; Artificial Ligament Fixation…The firm is recalling ToggleLocs and Ziploops manufactured in May and July of 2014 as they were not… | Biomet, Inc. | 02/26/2015Terminated |
| Z-2228-2013 Class II | OSTEORAPTOR CURVED 2.3 mm Suture Anchor SA ULTRABRAID COBRAID Suture, Blue; Part Number:…Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. | Smith & Nephew, Inc. Endoscopy Division | 08/06/2013Terminated |
| Z-2227-2013 Class II | OSTEORAPTOR CURVED 2.3 mm Suture Anchor ULTRABRAID COBRAID Suture, Black; Part Number:…Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. | Smith & Nephew, Inc. Endoscopy Division | 08/06/2013Terminated |
| Z-2226-2013 Class II | OSTEORAPTOR 2.9 mm Suture Anchor with 1 ULTRABRAID Suture, White; Part Number: 72202165…Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. | Smith & Nephew, Inc. Endoscopy Division | 08/06/2013Terminated |
| Z-2225-2013 Class II | OSTEORAPTOR 2.9 mm Suture Anchor with 2 ULTRABRAID Suture, White / Black; Part Number:…Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. | Smith & Nephew, Inc. Endoscopy Division | 08/06/2013Terminated |
| Z-2224-2013 Class II | OSTOSTEORAPTOR 2.9 mm Suture Anchor with 1 ULTRABRAID COBRAID Suture, Blue; Part Number:…Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. | Smith & Nephew, Inc. Endoscopy Division | 08/06/2013Terminated |
| Z-2223-2013 Class II | OSTEORAPTOR 2.3 mm Suture Anchor with 1 ULTRABRAID COBRAID Suture, Black; Part Number:…Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. | Smith & Nephew, Inc. Endoscopy Division | 08/06/2013Terminated |
| Z-2222-2013 Class II | OSTEORAPTOR 2.3 mm with 1 ULTRABRAID Suture, White; Part Number: 72201991 Biodegradable…Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. | Smith & Nephew, Inc. Endoscopy Division | 08/06/2013Terminated |
| Z-2221-2013 Class II | OSTEORAPTOR 2.9 mm Suture Anchor with 2 ULTRABRAID Suture, White / Blue ; Part Number:…Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. | Smith & Nephew, Inc. Endoscopy Division | 08/06/2013Terminated |
| Z-2220-2013 Class II | OSTEORAPTOR 2.3 mm Suture Anchor with ULTRABRAID COBRAID Suture, Blue; Part Number:…Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. | Smith & Nephew, Inc. Endoscopy Division | 08/06/2013Terminated |
| Z-1810-2008 | Lupine BR Anchor w/Orthocord TCP/PLGA Absorbable Anchor, size 2 (5 metric) Braided…Lupine BR Anchor w/Orthocord was assembled with an incorrect suture configuration. The suture loop was not… | DePuy Mitek, Inc., a Johnson & Johnson Co. | 04/29/2008Terminated |