Atlas FDA

JDR

232 FDA 510(k) clearances · Product code

90 daysmedian time to decision
313 days90th percentile
232clearances measured

FDA profile

Official device name
Staple, Fixation, Bone
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3030
Medical specialty
Orthopedic
Flags
Implant
Adverse events (MAUDE)
2021: 210 · 2022: 202 · 2023: 175 · 2024: 206 · 2025: 318 · 2026: 256
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Megalodon Dynamic Compression System (K261121)Paragon 28, Inc.2026-08-06
Linkt Compression Staple System (K250712)Trax Surgical2025-05-14
Medline UNITE® REFLEX® Hybrid Nitinol Implant System (K243888)Medline Industries, LP2025-04-11
Arthrex DynaNite Nitinol Staples (K243742)Arthrex, Inc.2025-01-31
TMC Compression Implant System (K243658)Treace Medical Concepts2024-12-26
TMC Compression Implant System (K242415)Treace Medical Concepts2024-09-06
COGNiTiON™ Staple System (K240212)Ortho Solutions UK , Ltd.2024-02-23
A’TOMIC™ Nitinol Fixation System (K232990)Rmr Ortho, LLC2024-01-12
arcad® 2.0 Duo & Quadro osteosynthesis compressive staples (K230724)Novastep2023-12-04
Medline UNITE® REFLEX® Nitinol Staple Kit (K232905)Medline Industries, LP2023-10-19
StealthFix Intraosseous Fixation System (K232324)Medartis, Inc.2023-08-30
Treace Medical Concepts (TMC) Compression Implant System (K232387)Treace Medical Concepts2023-08-28
NITINEX Memory Compression Staple (K231493)Vilex, LLC2023-08-11
Medline UNITE® REFLEX® Nitinol Staple System (K231885)Medline Industries, LP2023-08-09
Extremity Staple (K231458)Restor3D2023-08-03
JAWS Nitinol Staple System (K230550)Paragon 28, Inc.2023-05-11
JAWS Nitinol Staple System (K223056)Paragon 28, Inc.2023-02-16
Treace Medical Concepts (TMC) Implant Fixation System (K222645)Treace Medical Concepts2022-11-21
Tyber Medical Staple Fixation System (various) (K221947)Tyber Medical, LLC2022-10-20
DynaClip® Bone Staple (K220812)MedShape, Inc.2022-08-19
EasyClip® and EasyClip® Xpress (K210582)Stryker GmbH2022-06-10
StealthFix Intraosseous Fixation System (K220181)Nextremity Solutions, Inc.2022-03-22
FuseForce™ Flex Dynamic Compression System (K203832)Wright Medical2021-05-07
Medline UNITE REFLEX Nitinol Staple System (K210482)Medline Industries, Inc.2021-04-22
Ligament Staple (K210456)Medacta International S.A.2021-04-12
Arthrex DynaNite Nitinol Staples (K203180)Arthrex, Inc.2020-12-16
DynaClip Bone Staple (K193305)MedShape, Inc.2020-04-23
Superelastic Staple (K192447)Neosteo2020-02-28
DePuy Synthes Hammertoe Continuous Compression Implant (K191463)Synthes (USA) Products, LLC2020-02-26
APTUS Foot System (K191636)Medartis AG2019-08-16
TriMAX Implant System (K190722)Crossroads Extemity Systems, LLC2019-08-16
TriMed Nitinol Staple System (K190166)TriMed, Inc.2019-07-01
VERTEX Nitinol Staple System (K182943)Nvision Biomedical Technologies, LLC2019-04-04
Geo Staple System (K182212)Gramercy Extremity Orthopedics, LLC2019-01-11
DynaClipTM Bone Staple (K181781)MedShape, Inc.2018-11-05
DynaBridge (K181815)Fusion Orthopedics, LLC2018-10-15
MotoCLIP/HiMAX Step Staple Implant System (K181866)Crossroads Extremity Systems, LLC2018-08-09
DePuy Synthes Static Staples (K180544)Synthes (USA) Products, LLC2018-07-24
MotoCLIP/HiMAX Implant System (K181410)Crossroads Extremity Systems, LLC2018-06-29
Clench Compression Staple (K173775)F & A Foundation, LLC D.B.A. Reign Medical2018-04-06
Orbitum Bone Staple Implant, X and VI (K173693)Orthovestments, LLC2018-02-23
ExoToe Staple (K172205)Exotoe, LLC2018-01-11
Arthrex DynaNite Nitinol Staple (K172052)Arthrex, Inc.2017-12-13
SNIPER STAPLE SYSTEM, NON-STERILE (K172405)Trilliant Surgical2017-12-11
Compressyn™ Staple (K171473)Dallen Medical, Inc.2017-11-07
JAWS(TM) Nitinol Staple System (K170923)Paragon 282017-07-24
EPIC Extremely Small Staple (K163226)Epic Extremely, LLC2017-05-16
Sniper Staple System (K162354)Trilliant Surgical, Ltd.2017-04-20
EasyClip Xpress (K162321)Restore Surgical, LLC Dba Instratek2017-02-10
Stealth Staple System (K163440)First Ray, LLC2017-02-01
Memodyn Staple (K161587)Austin & Associates, Inc./Telos Medical Equipment2017-02-01
NeoSpan Compression Staple Impant w/instruments (K161426)In2bones USA, LLC2016-10-24
EasyStep (K160813)Stryker GmbH2016-07-26
First Ray Internal Bone Staple System (K153622)First Ray, LLC2016-04-08
OS2(R)-VP Varisation Staple (K153770)In2bones Sas2016-03-21
OS2-C Compression Staple (K153395)In2bones Sas2016-02-18
dynaMX Tabbed Staple (K153129)Mx Orthopedics, Corp.2016-01-28
PediatrOS RigidTack/FlexTack (K151762)Merete Medical GmbH2015-12-28
TiTHON Staple with OsseoTi Technology (K151615)Biomet Manufacturing Corp2015-10-02
Arcus Staple System (K151160)Nextremity Solutions, Inc.2015-09-04
dynaMX Compression Staple (K143622)Mx Orthopedics, Corp.2015-06-17
Elite Nitinol Fixation System (K150125)Biomedical Enterprises, Inc.2015-05-11
OS2-V Varisation Staple (K143323)In2bones Sas2015-02-26
SnapShot Fixation System (K143037)Biomet Manufacturing Corp2015-01-20
ARCAD COMPRESSIVE OSTEOSYNTHESIS STAPLE, EXPRESS COMPRESSIVE OSTEOSYNTHESIS STAPLE (K142111)Novatsep2014-12-19
TOGGLELOC AND JUGGERLOC IMPLANTS/INSTRUMENTS/KITS (K141263)Biomet Manufacturing Corp2014-11-19
Speed, Speed Shift, Speed Titan, Speed Arc (K142292)Biomedical Enterprises, Inc.2014-11-17
CrossCLIP Implant System (K142727)Orthodiscovery Group, LLC(D.B.A. Crossroads Extremity Systems2014-10-24
ORTHOHELIX STAPLE SYSTEM (K142148)Orthohelix Surgical Designs, Inc.2014-08-21
INSTAFIX SHAPE MEMORY FIXATION SYSTEM (K141550)Ot Medical2014-07-11
COMPRESSYN STAPLE (K140358)Dallen Medical, Inc.2014-06-02
SPEED ARC (K133270)Biomedical Enterprises, Inc.2014-04-17
SPEED TRIAD (K133844)Biomedical Ent., Inc.2014-04-07
SPEED XL (K133780)Biomedical Ent., Inc.2014-03-19
STAPIX SUPERELASTIC IMPLANT BONE STAPLES (K133523)Instratek, Inc.2014-02-06
COMPRESSYN STAPLE (K132875)Dallen Medical, Inc.2013-12-30
RESTORE BUNION CORRECTION SYSTEM (K131061)Nextremity Solutions2013-08-28
ORTHOHELIX STAPLE SYSTEM (K130832)Orthohelix Surgical Designs, Inc.2013-08-15
FUSEFORCE IMPLANT SYSTEM (K124045)Solana Surgical, LLC2013-07-10
SPEED SHIFT (K124022)Biomedical Enterprises, Inc.2013-05-14
METASURG NITINOL STAPLE IMPLANT (K123926)Metasurg2013-05-03
MEMORY METAL STAPLES, EASYCLIP (K122113)Stryker Corp.2013-03-12
COMPRESSYN STAPLE (K122871)Dallen Medical, Inc.2013-02-07
SUPER STAPLE(TM) CLASSIC (K123363)Metric Medical Devices, Inc.2013-01-03
VILEX EZ-STAPLE (MEMORY BONE FIXATION STAPLE) (K112837)Vilex, Inc.2012-10-09
MEDISCOPE COMPRESSIOPN STAPLE AND ACCESSORIES (K102387)Mediscope Manufacturing, Inc.2011-10-24
SUSPENSION ACROMIOCLAVICULAR (AC) REPAIR SYSTEM (K102143)Suspension Orthopaedic Solutions, LLC2010-12-08
OSSTAPLE CHILL (K102107)Biomedical Ent., Inc.2010-09-03
OSTEORAPTOR SUTURE ANCHOR (K082215)Smith & Nephew Inc., Endoscopy Division2008-11-03
COMPOSITE HITCH SUTURE ANCHOR (K081172)Biomet Manufacturing Corp2008-07-17
ENDOBUTTON CONTINUOUS LOOP (CL) (K081098)Smith & Nephew Inc., Endoscopy Division2008-07-16
CAIS STAPLE (K073281)Depuy Mitek, A Johnson & Johnson Company2008-05-02
ARTHREX COMPRESSION STAPLE (K080111)Arthrex, Inc.2008-02-13
BIOPRO MEMORY STAPLE, MODELS 18062-18073 (K072298)Biopro, Inc.2007-10-29
REVERTO 55 AND 37 SHAPE MEMORY STAPLES (K071477)Core Essence Orthopaedics, LLC2007-08-15
INTRINSIC THERAPEUTICS FIXATION STAPLE (K071637)Intrinsic Therapeutics Incorporated2007-08-03
SBI STAFIX (K071479)Small Bone Innovations, Inc.2007-08-02
MINI QUICKANCHOR AND QUICKANCHOR PLUS WITH ORTHOCORD (K071257)Depuy Mitek, A Johnson & Johnson Company2007-06-29
NEXFIX COMPRESSION STAPLE (K070688)Nexa Orthopedics, Inc.2007-05-18
MEMOMETAL VARISATION, MODELS AV26-08, AV26-10, AV90-08 AND AV90-10 (K070033)Memometal Technologies2007-03-19
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Every clearance here is in the API, with alerts when new ones post.