FDA 510(k) Applications for Medical Device Product Code "KTT"
(Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K071852 | AAP IMPLANTATE AG | AAP APS SYSTEM | 08/29/2007 |
| K101170 | ACUTE INNOVATIONS LLC | ACUTE INNOVATIONS STERNAL FIXATION SYSTEM | 09/17/2010 |
| K141912 | ADVANCED ORTHOPAEDIC SOLUTIONS, INC. | AOS SMALL BONE EXTERNAL FIXATION, THREADED HALF PINS, AOS SMALL BONE EXTERNAL FIXATION, CARBON FIBER RODS, AOS SMALL BON | 10/29/2014 |
| K080408 | ADVANCED ORTHOPAEDIC SOLUTIONS, INC. | EXTERNAL FIXATION CLAMP 5.0 MM PIN X9.5MM ROD, MODEL 1151-100, EXTERNAL FIXATON CLAMP, 9.5MM ROD | 04/25/2008 |
| K102057 | AESCULAP IMPLANT SYSTEMS, LLC | TARGON FN SYSTEM | 12/21/2010 |
| K200491 | Aike (Shanghai) Medical Instrument Co., Ltd. | Bfix Orthopedic External Fixator Systems | 01/05/2021 |
| K051554 | ALLIANCE MEDICAL CORP. | ALLIANCE MEDICAL CORPORATION REPROCESSED EXTERNAL FIXATION DEVICES | 06/29/2005 |
| K052062 | ALLIANCE MEDICAL CORP. | ALLIANCE MEDICAL CORPORATION REPROCESSED EXTERNAL FIXATION DEVICES | 08/25/2005 |
| K052064 | ALLIANCE MEDICAL CORP. | ALLIANCE MEDICAL CORPORATION REPROCESSED EXTERNAL FIXATION DEVICES | 08/25/2005 |
| K052065 | ALLIANCE MEDICAL CORP. | ALLIANCE MEDICAL CORPORATION REPROCESSED EXTERNAL FIXATION DEVICES | 08/22/2005 |
| K032058 | ALLIANCE MEDICAL CORP. | MODIFICATION TO REPROCESSED SYNTHES EXTERNAL FIXATION DEVICES | 07/30/2003 |
| K012623 | ALLIANCE MEDICAL CORP. | REPROCESSED EXTERNAL FIXATION DEVICE | 06/24/2002 |
| K023714 | ALLIANCE MEDICAL CORP. | REPROCESSED EXTERNAL FIXATION DEVICE | 02/03/2003 |
| K052918 | ALLIANCE MEDICAL CORP. | REPROCESSED EXTERNAL FIXATION DEVICES | 01/27/2006 |
| K012648 | ALLIANCE MEDICAL CORP. | REPROCESSED HOWMEDICA EXTERNAL FIXATION DEVICES | 06/24/2002 |
| K964400 | ALPHATEC MFG., INC. | ALPHATEC EXTERNAL FIXATION SYSTEM | 04/28/1997 |
| K993873 | ALPHATEC MFG., INC. | ALPHATEC EXTERNAL FIXATION SYSTEM COMPRESSION/DISTRACTION ROD | 01/03/2000 |
| K091619 | ANGLEFIX | ANGLEFIX T LOCKING PLATE, MODELS AF-001 (PLATE), ST-1 (LOCKING SCREW) | 09/08/2009 |
| K200123 | Arrowhead DE, LLC | Accessories for the SixFix« Hexapod Fixator | 09/22/2020 |
| K162032 | Arrowhead DE, LLC | Arrowhead Mini-Rail Fixator | 02/21/2017 |
| K190069 | Arrowhead DE, LLC | SixFixÖ Hexapod Fixator and Deformity Analysis and Correction Software (DACS) | 05/14/2019 |
| K232897 | Arthrex Inc | Arthrex Small External Fixation System | 10/18/2023 |
| K140463 | ASCENSION ORTHOPEDIC | INTEGRA EXTERNAL FIXATION SYSTEM | 10/10/2014 |
| K160830 | Ascension Orthopedics | Integra External Fixation System | 07/06/2016 |
| K061759 | ASCENT HEALTHCARE SOLUTIONS | REPROCESSED EXTERNAL FIXATION DEVICE | 09/05/2006 |
| K181528 | Austin Miller Trauma LLC | Austin Miller Large External Fixation System | 02/28/2019 |
| K221787 | Auxein Medical Private Limited | Auxein's DHS/DCS Plate System | 11/30/2023 |
| K071395 | BIOMET MANUFACTURING CORP. | BIOMET VISION FOOTRING SYSTEM | 07/09/2007 |
| K081244 | BIOMET TRAUMA | LOWER EXTREMITY EXTERNAL FIXATION - EXPANDED INDICATIONS | 07/30/2008 |
| K102843 | BIOMET TRAUMA (AKA EBI LLC) | MAC MALE ADAPTER | 05/03/2011 |
| K980370 | BIOMET, INC. | BIOSYMMETRIC PROXIMAL INTERPHALANGEAL JOINT FIXATOR | 04/14/1998 |
| K110426 | BK MEDITECH CO., LTD. | DYNA-EXTOR II | 11/02/2011 |
| K150579 | CARDINAL HEALTH | Cardinal Health External Fixation System | 04/29/2015 |
| K113384 | CITIEFFE | EXTERNAL FIXATOR ST.A R 90 F4 | 05/01/2012 |
| K163323 | CITIEFFE s.r.l | Dolphix« External Fixation System MR Conditional | 03/20/2017 |
| K132363 | CITIEFFE S.R.L. | DOLPHIX EXTERNAL FIXATION SYSTEM | 01/16/2014 |
| K973231 | CORIN U.S.A. | THE CORIFIX DYNAMIC HIP SCREW SYSTEM | 11/20/1997 |
| K113106 | D.N.E., LLC | DNE EXTERNAL FIXATION SYSTEM | 01/04/2012 |
| K140158 | D.N.E., LLC | S.E.A.L. FRACTURE FUSION TUBE | 05/29/2014 |
| K052498 | DAVID J. SLUTSKY MD | FRAGMENT SPECIFIC FIXATOR | 10/17/2005 |
| K083789 | DEPUY ORTHOPAEDICS, INC. | ACE FISCHER EXTERNAL FIXATION SYSTEM | 03/23/2009 |
| K112218 | DEPUY ORTHOPAEDICS, INC. | ACE-FISCHER(R), TEMPFIX(R), HOFFMAN CLASSIC(TM) EXTERNAL FIXATORS | 12/15/2011 |
| K003397 | DEPUY ORTHOPAEDICS, INC. | COLLES C SERIES FRAME STERILE PACK | 01/29/2001 |
| K063509 | DEPUY ORTHOPAEDICS, INC. | DEPUY PEAK FX HIP PLATE | 01/04/2007 |
| K013503 | DEPUY ORTHOPAEDICS, INC. | MODIFICATION TO: STERILE COLLES CLASSIC FIXATOR | 11/16/2001 |
| K021933 | DEPUY ORTHOPAEDICS, INC. | TEMPFIX EXTERNAL FIXATION SYSTEM | 08/26/2002 |
| K043113 | DEPUY ORTHOPAEDICS, INC. | TEMPFIX EXTERNAL FIXATION SYSTEM, MR SAFE | 01/21/2005 |
| K172872 | DePuy Synthes | DePuy Synthes Femoral Neck System | 03/05/2018 |
| K231922 | Depuy Synthes | DEPUY SYNTHES MAXFRAME AUTOSTRUT System | 07/26/2023 |
| K972629 | DEPUY, INC. | DEPUY AE TK2 HIP SCREW SYSTEM | 10/09/1997 |
| K140822 | DEVISE ORTHO, INC. | DRIVE RAIL SYSTEM | 05/29/2014 |
| K031401 | DISCO-O-TECH MEDICAL TECHNOLOGIES, LTD. | FIXION DYNAMIC HIP SCREW SYSTEM (FIXION DHS) | 08/06/2003 |
| K151580 | DNE, LLC | D.N.E. External Fixation System | 02/16/2016 |
| K093057 | EBI, L.P. | BIOMET VISION FOOTRING SYSTEM | 12/01/2009 |
| K021312 | EBI, L.P. | EBI DFS OPTIROM ELBOW FIXATOR | 05/23/2002 |
| K021695 | EBI, L.P. | EBI DYNAFIX DIAPHYSEAL CORRECTION SYSTEM | 06/20/2002 |
| K052239 | EBI, L.P. | EBI DYNAFIX VISION FOOTPLATE SYSTEM | 09/21/2005 |
| K970290 | EBI, L.P. | EBI X FIX DYNAFIX MINI EXTERNAL FIXATION SYSTEM | 04/01/1997 |
| K011697 | EBI, L.P. | EBI XFIX ACCESS PELVIC FIXATOR | 06/27/2001 |
| K013540 | EBI, L.P. | EBI XFIX ACCESS PELVIC FIXATOR | 11/20/2001 |
| K001358 | EBI, L.P. | EBI XFIX DFS METAPHYSEAL CORRECTION SYSTEM | 05/23/2000 |
| K992515 | EBI, L.P. | EBI XFIX DFS OPTIROM ELBOW FIXATOR | 08/17/1999 |
| K000083 | EBI, L.P. | EBI XFIX DFS RAIL SYSTEM | 02/03/2000 |
| K000319 | EBI, L.P. | EBI XFIX DFS SYSTEM | 02/25/2000 |
| K012024 | EBI, L.P. | EBI XFIX DFS SYSTEM | 07/25/2001 |
| K013378 | EBI, L.P. | EBI XFIX DFS SYSTEM | 11/08/2001 |
| K021091 | EBI, L.P. | EBI XFIX DFS SYSTEM | 05/03/2002 |
| K022319 | EBI, L.P. | EBI XFIX DFS SYSTEM | 08/12/2002 |
| K023399 | EBI, L.P. | EBI XFIX DFS SYSTEM | 10/25/2002 |
| K031645 | EBI, L.P. | EBI XFIX DFS SYSTEM | 06/25/2003 |
| K031919 | EBI, L.P. | EBI XFIX DFS SYSTEM | 09/04/2003 |
| K040935 | EBI, L.P. | EBI XFIX DFS SYSTEM | 07/06/2004 |
| K993649 | EBI, L.P. | EBI XFIX DFS WRISTFIX SYSTEM | 11/19/1999 |
| K031093 | EBI, L.P. | EBI XFIX OPTIROM KNEE FIXATOR | 07/10/2003 |
| K021031 | EBI, L.P. | EBI XFIX RAIL SYSTEM | 05/16/2002 |
| K993886 | EBI, L.P. | EBI XFIX VISION FIXATION SYSTEM | 12/14/1999 |
| K030372 | EBI, L.P. | MODIFICATION TO EBI DYNAFIX DIAPHYSEAL CORRECTION SYSTEM | 03/06/2003 |
| K011711 | EBI, L.P. | MODIFICATION TO EBI EFIX VISION FIXATION SYSTEM | 06/29/2001 |
| K020403 | EBI, L.P. | MODIFICATION TO EBI XFIX DFS OPTIROM ELBOW FIXATOR | 03/08/2002 |
| K010437 | EBI, L.P. | MODIFICATION TO EBI XFIX DFS RAIL SYSTEM | 03/13/2001 |
| K014276 | EBI, L.P. | MODIFICATION TO EBI XFIX DFS SYSTEM | 03/01/2002 |
| K023324 | EBI, L.P. | MODIFICATION TO EBI XFIX DFS SYSTEM | 10/18/2002 |
| K024129 | EBI, L.P. | MODIFICATION TO EBI XFIX DFS SYSTEM | 01/15/2003 |
| K024248 | EBI, L.P. | MODIFICATION TO EBI XFIX DFS SYSTEM METAPHYSEAL CORRECTION SYSTEM | 01/22/2003 |
| K014194 | EBI, L.P. | MODIFICATION TO EBI XFIX VISION FIXATION SYSTEM | 01/17/2002 |
| K020141 | EBI, L.P. | MODIFICATION TO EBI XFIX VISION FIXATION SYSTEM | 02/05/2002 |
| K033635 | EBI, L.P. | MODIFICATION TO EBI XFIX VISION FIXATION SYSTEM | 12/03/2003 |
| K040833 | EBI, L.P. | MODIFICATION TO EBI XFIX VISION FIXATION SYSTEM | 04/29/2004 |
| K111376 | EBI, LLC | CONSTRUX EXTERNAL FIXATION DEVICE | 08/03/2011 |
| K981483 | ELECTRO-BIOLOGY, INC. | EBI DFS JOINT FIXATOR, MODEL 02800 | 07/08/1998 |
| K961433 | ELECTRO-BIOLOGY, INC. | EBI X FIX DYNAFIX SYSTEM/EBI DFS DISTAL RADIUS FIXATOR SC BONE SCREWS | 06/28/1996 |
| K991941 | ELECTRO-BIOLOGY, INC. | EBI XFIX DFS RAIL SYSTEM | 08/19/1999 |
| K140675 | EMERGE MEDICAL, INC. | EMERGE EXTERNAL FIXATION SYSTEM | 06/10/2014 |
| K111155 | EXTRAORTHO INC | XTRAFIX EXTERNAL FIXATION SYSTEM | 10/20/2011 |
| K113383 | EXTRAORTHO, INC. | XTRAFIX EXTERNAL FIXATION SYSTEM | 06/26/2012 |
| K241563 | Extremity Medical, LLC | Extremity Medical External Fixation System | 02/21/2025 |
| K251128 | Extremity Medical, LLC | Extremity Medical External Fixation System | 05/07/2025 |
| K964094 | FERGUSON MEDICAL | MINIFIX | 11/27/1996 |
| K023314 | FIXANO SA | MICROFIX | 10/18/2002 |
| K012062 | FIXANO SA | PF2 | 09/27/2001 |
| K012078 | FIXANO SA | RADIOFIX | 09/27/2001 |
| K022771 | FIXANO SA | TWIN FIX | 09/23/2002 |
| K160972 | Gexfix International Corp. | Gexfix External Fixation | 12/28/2016 |
| K052605 | GEXFIX USA INC. | EXTERNAL FIXATION | 11/10/2005 |
| K172438 | Globus Medical Inc. | ARBOR External Fixation System | 01/12/2018 |
| K200343 | GLW Medical Innovation | FusionFrame Ring Lock System | 09/14/2020 |
| K033112 | HAND BIOMECHANICS LAB, INC. | WRISTJACK ORIF SYSTEM, WRISTJACK ORIF SYSTEM, NON-STERILE, MODELS CFD-347, CFD-347-NS | 11/05/2003 |
| K041081 | HAND INNOVATIONS, INC. | FRAGMENT PLATE SYSTEM, SCREWS, PINS AND K-WIRES | 07/01/2004 |
| K061748 | HAND INNOVATIONS, LLC. | FRAGMENT PLATE SYSTEM | 07/17/2006 |
| K163486 | HNM Total Recon, LLC | DRACO Locking Bone Screws; DRACO Compression Screws; DRACO MetaFuse L Plates; DRACO MetaFuse BLP Plates; DRACO MetaFuse MTP Plates, Tak· Plates, DuoTak· Plates, Open Wedge Plates, Osteoplate Plates, Plantar Plates, Calcaneus Offset Locking Plates | 07/24/2017 |
| K961213 | HOWMEDICA CORP. | ALTA DOME AND PLUNGER (MEC HIP BOLT) | 06/13/1996 |
| K955306 | HOWMEDICA CORP. | OMEGA+ COMPRESSION SCREW SYSTEM | 04/10/1996 |
| K050048 | HOWMEDICA OSTEONICS CORP | HOFFMAN II MICRO EXTERNAL FIXATION SYSTEM | 03/04/2005 |
| K053038 | HOWMEDICA OSTEONICS CORP | HOFFMANN II COMPACT MRI EXTERNAL FIXATION SYSTEM | 11/22/2005 |
| K053472 | HOWMEDICA OSTEONICS CORP | HOFFMANN II MRI EXTERNAL FIXATION SYSTEM | 01/11/2006 |
| K053349 | HOWMEDICA OSTEONICS CORP | HOFFMANN II ROD TO WIRE COUPLING | 12/09/2005 |
| K052037 | HOWMEDICA OSTEONICS CORP | MODIFICATION TO HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM | 08/05/2005 |
| K070454 | HOWMEDICA OSTEONICS CORP | OMEGA 3 SUPRACONDYLAR PLATE | 04/12/2007 |
| K062066 | HOWMEDICA OSTEONICS CORP | OMEGA 3 SYSTEM | 08/15/2006 |
| K073527 | HOWMEDICA OSTEONICS CORP | VARIAX ELBOW SYSTEM | 02/14/2008 |
| K092834 | HOWMEDICA OSTEONICS CORP. | HOFFMAN XPRESS LINE EXTENSION | 10/08/2009 |
| K041706 | HOWMEDICA OSTEONICS CORP. | HOFFMANN II FOOT RING | 09/08/2004 |
| K042019 | HOWMEDICA OSTEONICS CORP. | HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM | 09/24/2004 |
| K073076 | HOWMEDICA OSTEONICS CORP. | HOFFMANN LIGHT SYSTEM | 02/15/2008 |
| K033476 | HOWMEDICA OSTEONICS CORP. | MODIFICATION TO HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM | 01/20/2004 |
| K041709 | HOWMEDICA OSTEONICS CORP. | NUMELOCK II SYSTEM | 09/08/2004 |
| K041001 | HOWMEDICA OSTEONICS CORP. | OMEGA 2 SYSTEM | 07/01/2004 |
| K081278 | HOWMEDICA OSTEONICS CORP. | OMEGA 3 TROCHANTERIC STABILIZING PLATE | 05/29/2008 |
| K020772 | HOWMEDICA OSTEONICS CORP. | OMEGA II SYSTEM | 06/05/2002 |
| K081284 | HOWMEDICA OSTEONICS CORP. | VARIAX DISTAL FIBULA PLATE | 07/18/2008 |
| K060613 | HOWMEDICA OSTEONICS CORP. | VARIAX LOCKING PLATE SYSTEM | 04/21/2006 |
| K973321 | HOWMEDICA, INC. | HOFFMANN II COMPACT PERIARTICULAR CLAMP | 11/20/1997 |
| K070724 | INTELLIGENT ORTHOPAEDICS LTD | IOS EXTERNAL FIXATOR, MODEL 2-0-0 | 05/16/2007 |
| K031875 | INTER-OS TECHNOLOGIES | INTER-OS LIMB LENGTHENER | 10/22/2003 |
| K152158 | Jeil Medical Corporation | ARIX Ankle System | 09/28/2015 |
| K100857 | JOHN J RICCIO | FUSION MEDICAL RING LOCK SYSTEM | 05/27/2010 |
| K072250 | KINAMED, INC. | SUPERCABLE GRIP AND PLATE SYSTEM | 11/09/2007 |
| K173883 | Life Spine Inc. | External Fixation System | 09/07/2018 |
| K964458 | LINK AMERICA, INC. | ELLIS EXTERNAL MINI-FIXATOR SYSTEM | 12/09/1996 |
| K093753 | MDPO, LLC | MDPO FRAME SYSTEM | 08/26/2010 |
| K063487 | MERETE MEDICAL GMBH | MERETE BLP SMALL FRAGMENT LOCKING BONE PLATE | 01/22/2007 |
| K102688 | MERETE MEDICAL GMBH | MERETE LOCKING BONE PLATE SYSTEM II | 12/03/2010 |
| K050457 | MERETE MEDICAL GMBH | MERETE METAFIX SMALL FRAGMENT BONE PLATE SYSTEM | 03/14/2005 |
| K090063 | MERETE MEDICAL, INC. | MERETE LOCKING BONE PLATE SYSTEM | 04/22/2009 |
| K070016 | MERIDAN MEDICAL | BLUE SHARK | 04/02/2007 |
| K240049 | Metric Medical Devices, Inc. | LINK(TM) External Fixator | 05/29/2024 |
| K012294 | MILLENNIUM MEDICAL TECHNOLOGIES, INC. | WRISTORE FIXATOR | 03/04/2002 |
| K181630 | New Standard Device DBA Metalogix | Revolution External Plating System | 05/29/2019 |
| K233025 | New Standard Device dba Metalogix | Revolution External Plating System | 05/30/2024 |
| K040064 | NEWMEDICAL TECHNOLOGY, INC. | NEWMEDICAL MICRO BONE DISTRACTOR/FIXATOR | 03/23/2004 |
| K122777 | NUTEK ORTHOPAEDICS, INC. | NBX - NON BRIDGING EXTERNAL FIXATOR HAND | 05/15/2013 |
| K082833 | NUTEK ORTHOPAEDICS, INC. | NBX - NON-BRIDGING EXTERNAL FIXATOR - SHOULDER | 02/05/2009 |
| K192181 | NuVasive Specialized Orthopedics, Inc. | PRECICE Plating System | 11/07/2019 |
| K242861 | Orthofix S.r.l. | TrueLok Elevate | 12/03/2024 |
| K153233 | ORTHOFIX SRL | Galaxy UNYCO System | 01/06/2016 |
| K170146 | Orthofix Srl | Galaxy UNYCO System | 10/12/2017 |
| K113770 | ORTHOFIX SRL | ORTHOFIX GALAXY FIXATION SYSTEM | 09/04/2012 |
| K142052 | ORTHOFIX SRL | ORTHOFIX GALAXY UNYCO DIAPHYSEAL TIBIA KIT | 12/05/2014 |
| K141760 | ORTHOFIX SRL | ORTHOFIX GALAXY WRIST | 12/08/2014 |
| K141078 | ORTHOFIX SRL | ORTHOFIX TL-HEX TRUE LOK HEXALOBE SYSTEM (TL-HEX) | 09/02/2014 |
| K152171 | ORTHOFIX SRL | Orthofix TL-HEX True Lok Hexapod System (TL-HEX) V1.4 | 09/28/2015 |
| K143125 | Orthofix Srl | Orthofix True Lok Hexapod System VI.3 | 12/10/2014 |
| K170650 | Orthofix Srl | Orthofix TrueLok Hexapod System (TL-HEX) V2.0 | 05/10/2017 |
| K212044 | Orthofix SRL | TrueLok Evo | 11/05/2021 |
| K051162 | ORTHONETX, INC. | GENEROS SB SMALL BONE DISTRACTION IMPLANT | 07/19/2005 |
| K213905 | OrthoNovis, Inc. | ONX Large External Fixation System | 08/25/2022 |
| K971993 | ORTHOPAEDIC DESIGNS, INC. | ODI COMPRESSION HIP SCREW SYSTEM | 11/12/1997 |
| K103015 | ORTHOPAEDIC DEVICE RESEARCH CENTER | ODRC-DYNAMIC HIP SCREW SYSTEM | 04/13/2011 |
| K171211 | Orthopaedic Implant Company | OIC External Fixation System | 09/27/2017 |
| K183682 | Orthopaedic Implant Company | OIC External Fixation System | 04/08/2019 |
| K211112 | Orthopaedic Implant Company | OIC External Fixation System | 05/05/2021 |
| K960014 | ORTHOPAEDIC INNOVATIONS, INC. | PRACTIFIX EXTERNAL FIXATION SYSTEM | 03/18/1996 |
| K220809 | OrthoPediatrics Corp. | Drive Rail System | 04/08/2022 |
| K243798 | OrthoPediatrics Corp. | Orthex External Fixation System | 03/07/2025 |
| K223786 | OrthoPediatrics Corp. | Orthex External Fixation System | 02/10/2023 |
| K191241 | OrthoSpin | AutoStrut | 08/14/2019 |
| K202810 | OrthoSpin Ltd | AutoStrut G2 | 01/06/2021 |
| K212895 | Paragon 28, Inc | Paragon 28 External Ring Fixation System | 11/08/2021 |
| K242452 | Paragon 28, Inc. | Monkey Bars Pin to Bar External Fixation System | 11/01/2024 |
| K232838 | Paragon 28, Inc. | Monkey RingsTM External Fixation System | 10/12/2023 |
| K170704 | Pega Medical Inc. | The Locking Pediatric Osteotomy Plate (LolliPOP) System | 09/08/2017 |
| K033856 | PETER STEVENS, MD | 5.0 CANNULATED DRILL PIN, 6.0 CANNULATED DRILL-PIN | 01/07/2005 |
| K000734 | PIONEER SURGICAL TECHNOLOGY | PIONEER SURGICAL TECHNOLOGY EXTENDED GTR, MODEL 501-601 | 05/05/2000 |
| K974409 | PLUS ORTHOPEDICS | FRIEDL GLIDING NAIL SYSTEM | 02/19/1998 |
| K033763 | PLUS ORTHOPEDICS | MODIFICATION TO SLIM GLIDING NAIL SYSTEM | 12/18/2003 |
| K020240 | PLUS ORTHOPEDICS | SLIM GLIDING NAIL SYSTEM | 02/22/2002 |
| K023851 | PRECIMED, INC. | PRECIMED HIP SCREW SYSTEM | 01/28/2003 |
| K091258 | QFX TECHNOLOGIES, INC. | EXTRAFIX EXTERNAL FIXATION SYSTEM | 07/24/2009 |
| K111993 | QUANTUM MEDICAL CONCEPTS, LLC. | FRAMEWALKER | 10/24/2011 |
| K101759 | QUANTUM MEDICAL CONCEPTS, LLC. | QUANTUM RING FIXATION SYSTEM MODEL ISF | 10/22/2010 |
| K051017 | R-X-FIX | R-X-FIX EXTERNAL FIXATOR | 06/29/2005 |
| K052005 | R&R MEDICAL, INC. | R&R EXTERNAL FIXATION SYSTEM | 09/06/2005 |
| K043174 | R&R MEDICAL, INC. | STEALTH FUSION SYSTEM, MODEL RR 1000 | 02/07/2005 |
| K110965 | RENOVIS SURGICAL TECHNOLOGIES, LLC | RENOVIS T 710 LARGE EXTERNAL FIXATION SYSTEM | 05/11/2011 |
| K241769 | Response Ortho Solutions LLC | Response Ortho Metaphyseal Hinge Fixator System | 09/18/2024 |
| K020311 | RIGID FX ORTHOPEDICS, INCORPORATED | CLEARVIEW WRIST FIXATOR | 04/29/2002 |
| K022423 | RIGID FX ORTHOPEDICS, INCORPORATED | EXTERNAL FIXATION RING | 09/17/2002 |
| K200518 | S H Pitkar Orthotools Pvt Ltd | Pitkar External Fixation System - Rail Mechanism | 07/29/2020 |
| K200728 | S H Pitkar Orthotools Pvt Ltd. | Pitkar DeftFix System | 10/06/2020 |
| K190486 | S H Pitkar Orthotools Pvt Ltd. | Pitkar External Fixation System | 10/16/2019 |
| K202833 | Sequel Medical Inc. | Sequel External Fixation Device | 01/19/2021 |
| K043289 | SIGNAL MEDICAL CORP. | E-Z FRAME EXTERNAL SURGICAL SUPPORT BOOT | 02/11/2005 |
| K071394 | SMALL BONE INNOVATIONS INC. | MODIFICATION TO:SBI RINGFIX | 06/29/2007 |
| K093550 | SMALL BONE INNOVATIONS, INC. | MINI RAIL EXTERNAL FIXATOR SYSTEM | 01/07/2010 |
| K201253 | Smith & Nephew | Modular Rail System, TAYLOR SPATIAL FRAME External Fixator, JET-X Fixator, ILIZAROV External Fixator, Other External Fixation | 12/08/2020 |
| K962808 | SMITH & NEPHEW RICHARDS, INC. | ILIZAROV EXTERNAL FIXATION SYSTEM | 08/19/1996 |
| K142520 | Smith & Nephew, Inc | Smith & Nephew, Inc. Spatialframe.com V5.0 Web-based software | 11/20/2014 |
| K092002 | SMITH & NEPHEW, INC. | AFGHAN EXTERNAL FIXATOR | 12/10/2009 |
| K202762 | Smith & Nephew, Inc. | Circular Fixation with Balanced Cable Transport | 11/16/2020 |
| K031181 | SMITH & NEPHEW, INC. | EXTERNAL FIXATION SYSTEMS | 07/14/2003 |
| K050849 | SMITH & NEPHEW, INC. | HA COATED LAG SCREW | 05/04/2005 |
| K042436 | SMITH & NEPHEW, INC. | IIIZAROV PULLEY SYSTEM | 10/07/2004 |
| K130479 | SMITH & NEPHEW, INC. | ILIZAROV DRILL TIP WIRES | 05/14/2013 |
| K042312 | SMITH & NEPHEW, INC. | JET-X BAR CLAMPS AND PIN CLAMPS-NON-MAGNETIC/MR SAFE | 09/24/2004 |
| K100795 | SMITH & NEPHEW, INC. | JET-X BAR SYSTEM CLAMPS AND POSTS REPROCESSING | 09/02/2010 |
| K072212 | SMITH & NEPHEW, INC. | JET-X BAR SYSTEM CLAMPS, BARS AND POSTS-MR SAFE | 03/07/2008 |
| K210953 | Smith & Nephew, Inc. | SMART Taylor Spatial Frame | 07/29/2021 |
| K093047 | SMITH & NEPHEW, INC. | SMITH & NEPHEW CIRCULAR FIXATION SYSTEM | 09/27/2010 |
| K993289 | SMITH & NEPHEW, INC. | SMITH & NEPHEW COMPRESSION HIP SCREW SYSTEM, INTRAMEDULLARY HIP SCREW SYSTEM | 12/20/1999 |
| K090926 | SMITH & NEPHEW, INC. | SMITH & NEPHEW RAIL SYSTEM | 06/08/2009 |
| K110069 | SMITH & NEPHEW, INC. | SMITH & NEPHEW, INC SPATIALFRAME V4.1 WEB-BASED SOFTWARE | 02/08/2011 |
| K970748 | SMITH & NEPHEW, INC., ORTHOPAEDIC DIV. | TAYLOR SPATIAL FRAME EXTERNAL FIXATION SYSTEM | 05/09/1997 |
| K051957 | STERILEMED INC. | REPROCESSED EXTERNAL FIXATION DEVICE | 09/21/2005 |
| K081342 | STERILMED, INC. | REPROCESSED EXTERNAL FIXATION ACCESSORIES | 08/13/2008 |
| K081586 | STERILMED, INC. | REPROCESSED EXTERNAL FIXATION DEVICE | 08/18/2008 |
| K083636 | STERILMED, INC. | REPROCESSED EXTERNAL FIXATION DEVICE | 03/02/2009 |
| K122284 | STRYKER CORP. | HOFFMANN 3 | 10/24/2012 |
| K111786 | STRYKER CORP. | HOFFMANN 3 MODULAR EXTERNAL FIXATION SYSTEM | 01/26/2012 |
| K121252 | STRYKER CORP. | HOFFMANN 3 MODULAR EXTERNAL FIXATION SYSTEM | 07/25/2012 |
| K113327 | STRYKER CORP. | HOFFMANN LRF (LIMB RECONSTRUCTION FRAME) SYSTEM | 03/29/2012 |
| K161753 | STRYKER GMBH | Hoffman LRF System | 11/15/2016 |
| K153377 | Stryker GmbH | Hoffmann LRF (Limb Reconstruction Frame) System | 04/11/2016 |
| K163656 | Stryker GmbH | Hoffmann LRF System | 04/14/2017 |
| K182968 | Stryker GmbH | Hoffmann LRF System | 01/25/2019 |
| K203568 | Stryker GmbH | Hoffmann LRF System | 02/01/2021 |
| K233741 | Stryker GmbH | Hoffmann LRF System | 12/21/2023 |
| K153415 | STRYKER SUSTAINABILITY SOLUTIONS | Reprocessed Stryker External Fixation Devices | 01/13/2016 |
| K130334 | Stryker Trauma AG | HOFFMANN LRF (LIMB RECONSTRUCTION FRAME SYSTEM) | 05/03/2013 |
| K130907 | Stryker Trauma AG | HOFFMANN LRF (LIMB RECONSTRUCTION FRAME) SYSTEM | 06/10/2013 |
| K140961 | Stryker Trauma AG | HOFFMANN LRF (LIMB RECONSTRUCTION FRAME) SYSTEM | 11/10/2014 |
| K083582 | SURGICAL IMPLANT GENERATION NETWORK (SIGN) | SIGN HIP CONSTRUCT (SHC), MODEL: 701 | 08/26/2009 |
| K180580 | Surgical Instrument Service and Savings Inc | Medline ReNewal Reprocessed Smith & Nephew Jet-X External Fixation Devices | 07/27/2018 |
| K171911 | Surgical Instrument Service and Savings Inc | Medline ReNewal Reprocessed Synthes External Fixation Systems | 11/09/2017 |
| K983873 | SYNTEC SCIENTIFIC CORP. | SYNTEC-TAICHUNG NON-STERILE DHS/DCS PLATE SYSTEM | 12/30/1998 |
| K984364 | SYNTEC SCIENTIFIC CORP. | SYNTEC-TAICHUNG NON-STERILE SMALL ORTHOPEDIC FIXATION SYSTEM, MODEL 71100, 294-300,400 & 292-730/820 | 03/02/1999 |
| K122455 | SYNTHES | SYNTHES SMALL EXTERNAL FIXATION SYSTEM, SYNTHES LARGE EXTERNAL FIXATION SYSTEM | 04/11/2013 |
| K033995 | SYNTHES (USA) | 3.5 MM LCP DISTAL HUMERUS SYSTEM | 03/01/2004 |
| K010344 | SYNTHES (USA) | ADJUSTABLE LARGE FIXATOR SYSTEM | 05/03/2001 |
| K000684 | SYNTHES (USA) | SMALL FRAGMENT DYNAMIC COMPRESSION LOCKING (DCL) SYSTEM | 04/28/2000 |
| K984498 | SYNTHES (USA) | SYNTHES (USA) ARTICULATING DISTAL RADIUS (ADRF) SYSTEM | 02/18/1999 |
| K051600 | SYNTHES (USA) | SYNTHES (USA) DISTRACTION OSTEOGENESIS SYSTEM | 07/27/2005 |
| K043039 | SYNTHES (USA) | SYNTHES (USA) EXTERNAL FIXATION COMPONENT LINE EXTENSION - MR SAFE | 01/18/2005 |
| K010766 | SYNTHES (USA) | SYNTHES (USA) LARGE FRAGMENT LOCKING COMPRESSION PLATE (LCP) SYSTEM-T PLATE | 06/12/2001 |
| K041911 | SYNTHES (USA) | SYNTHES (USA) LCP CURVED PLATES | 09/08/2004 |
| K033556 | SYNTHES (USA) | SYNTHES (USA) LCP DYNAMIC HELICAL HIP SYSTEM | 01/13/2004 |
| K051049 | SYNTHES (USA) | SYNTHES (USA) LOW-PROFILE WRIST FIXATOR | 07/13/2005 |
| K011034 | SYNTHES (USA) | SYNTHES (USA) MEDIUM EXTERNAL FIXATION SYSTEM | 06/27/2001 |
| K033411 | SYNTHES (USA) | SYNTHES (USA) STERILE ADJUSTABLE DISTAL RADIUS FIXATOR (ADRF) WITH 4.0MM/3.0MM SELF-DRILLING SCHANZ SCREWS | 11/26/2003 |
| K031573 | SYNTHES (USA) | SYNTHES 3.5 MM LOW PROFILE PELVIC RECONSTRUCTION PLATE | 06/06/2003 |
| K010518 | SYNTHES (USA) | SYNTHES ANTEROLATERAL CALCANEAL PLATE | 05/23/2001 |
| K974537 | SYNTHES (USA) | SYNTHES CANNULATED ANGLE BLADE PLATE (CABP) SYSTEM | 02/18/1998 |
| K973017 | SYNTHES (USA) | SYNTHES COMBINATION CLAMP AND DYNAMIZATION CLIP | 10/16/1997 |
| K092190 | SYNTHES (USA) | SYNTHES DISTRACTION OSTEOGENESIS SYSTEM, MR CONDITIONAL WITH EXPANDED INDICATIONS | 05/11/2010 |
| K090658 | SYNTHES (USA) | SYNTHES EXTERNAL FIXATION DEVICES, MR CONDITIONAL | 03/03/2010 |
| K082650 | SYNTHES (USA) | SYNTHES LARGE EXTERNAL FIXATION, MR CONDITIONAL | 11/18/2008 |
| K000682 | SYNTHES (USA) | SYNTHES LARGE FRAGMENT DYNAMIC COMPRESSION LOCKING (DCL) SYSTEM | 05/01/2000 |
| K042895 | SYNTHES (USA) | SYNTHES LCP DYNAMIC HELICAL HIP SYSTEM, ADDITIONAL HELIX BLADES | 11/16/2004 |
| K040258 | SYNTHES (USA) | SYNTHES MEDIUM EXTERNAL FIXATION SYSTEM-MR SAFE | 03/23/2004 |
| K961350 | SYNTHES (USA) | SYNTHES MINI EXTERNAL FIXATOR | 06/28/1996 |
| K033158 | SYNTHES (USA) | SYNTHES REPROCESSED EXTERNAL FIXATION DEVICES | 11/05/2003 |
| K031724 | SYNTHES (USA) | SYNTHES SMALL COBINATION CLAMP-MR SAFE | 07/14/2003 |
| K031725 | SYNTHES (USA) | SYNTHES TI-15 MO LOCKING DISTAL RADIUS PLATING SYSTEM | 06/24/2003 |
| K962484 | SYNTHES (USA) | SYNTHES TITANIUM EXTERNAL FIXATOR CLAMPS (TI EFC) | 09/05/1996 |
| K023941 | SYNTHES (USA) | SYNTHES TOMOFIX OSTEOTOMY SYSTEM | 01/23/2003 |
| K182154 | Synthes (USA) Products, LLC | Depuy Synthes Femoral Neck System | 10/16/2018 |
| K211313 | Synthes (USA) Products, LLC | MAXFRAME Multi-Axial Correction System (aka MAXFRAME) | 05/25/2021 |
| K161417 | SYNTHES USA, LLC | DePuy Synthes MAXFRAME Multi-Axial Correction System | 11/10/2016 |
| K170482 | TASARIMMED TIBBI MAMULLER SANAYI VE TICARET A.S | Spider Frame External Fixation System | 09/27/2017 |
| K101338 | TECHNOLOGIA Y DISENO INDUSTRIAL, S.A DE C.V | NEWFIX EXTERNAL FIXATION SYSTEM | 03/14/2011 |
| K122210 | TECNOLOGIA Y DISENO INDUSTRIAL, S.A DE C.V | NEWFIX EXTERNAL FIXATION SYSTEM | 04/19/2013 |
| K113123 | THE ORTHOPAEDIC IMPLANT COMPANY | OIC CANNULATED SCREW SYSTEM, OIC SLIDING HIP SCREW (SHS) SYSTEM | 01/12/2012 |
| K063551 | TORNIER | AEQUALIS HUMERAL PLATE | 12/22/2006 |
| K060545 | TORNIER | UNITY HUMERAL PLATE | 04/21/2006 |
| K031687 | VANGUARD MEDICAL CONCEPTS, INC. | VANGUARD REPROCESSED EXTERNAL FIXATION DEVICES | 04/30/2004 |
| K051180 | VANGUARD MEDICAL CONCEPTS, INC. | VANGUARD REPROCESSED EXTERNAL FIXATION DEVICES | 07/22/2005 |
| K051616 | VANGUARD MEDICAL CONCEPTS, INC. | VANGUARD REPROCESSED EXTERNAL FIXATION DEVICES | 09/06/2005 |
| K053051 | VANGUARD MEDICAL CONCEPTS, INC. | VANGUARD REPROCESSED EXTERNAL FIXATION DEVICES | 12/22/2005 |
| K151881 | VILEX IN TENNESSEE, INC | X-Fix Line Additions | 03/24/2016 |
| K212552 | Vilex LLC | Correx Software | 10/12/2021 |
| K052196 | VILEX, INC. | VILEX X-FIX | 11/22/2005 |
| K202143 | Vilex, LLC | Dynex Micro | 09/11/2020 |
| K202054 | Vilex, LLC | Dynex Ring Fixation System, Diametrix Ring Fixation System | 08/24/2020 |
| K964880 | WALTER ABENDSCHEIN, M.D. | VARI-ANGLE HIP SCREW (VHS) SYSTEM | 10/16/1997 |
| K011603 | WALTER ABENDSCHEIN, M.D. | VHS PEDIATRIC HIP SCREW SYSTEM | 08/15/2001 |
| K991806 | WALTER ABENDSCHEIN, M.D. | VHS SUPRACONDYLAR PLATE SYSTEM | 08/06/1999 |
| K193368 | WishBone Medical, Inc. | Smart Correction System | 09/18/2020 |
| K231461 | WishBone Medical, Inc. | Smart Correction System (HA Half Pins) | 06/16/2023 |
| K221366 | WishBone Medical, Inc. | Smart Correction System Rings and Compatible HA-Coated Half Pins | 06/06/2022 |
| K162033 | WRIGHT MEDICAL | SALVATION External Fixation System | 03/06/2017 |
| K042358 | WRIGHT MEDICAL TECHNOLOGY, INC. | LOCON VLS DISTAL RADIUS PLATE SYSTEM | 10/07/2004 |
| K962251 | WRIGHT MEDICAL TECHNOLOGY, INC. | MEDOFF SLIDING PLATE (PROPOSED NAME) | 01/22/1997 |
| K150640 | WRIGHT MEDICAL TECHNOLOGY, INC. | RX-FIX Mini Rail External Fixator | 12/01/2015 |
| K150004 | WRIGHT MEDICAL TECHNOLOGY, INC. | SALVATION External Fixation System | 03/04/2015 |
| K180832 | Wright Medical Technology, Inc. | SALVATION External Fixation System | 06/06/2018 |
| K152045 | WRIGHT MEDICAL TECHNOLOGY, INC. | SALVATION« External Fixation System | 08/21/2015 |
| K153635 | WRIGHT MEDICAL TECHNOLOGY, INC. | SALVATION(R) External Fixation System | 01/13/2016 |
| K100137 | WRIGHT MEDICAL TECHNOLOGY, INC. | SIDEKICK CIRCULAR FIXATOR SYSTEM: STRUTS AND HINGES | 06/10/2010 |
| K143220 | WRIGHT MEDICAL TECHNOLOGY, INC. | SIDEKICK EZ FRAME External Fixation System | 01/08/2015 |
| K130044 | WRIGHT MEDICAL TECHNOLOGY, INC. | SIDEKICK EZ FRAME EXTERNAL FIXATION SYSTEM | 04/05/2013 |
| K080071 | WRIGHT MEDICAL TECHNOLOGY, INC. | SIDEKICK RAIL FIXATOR | 02/07/2008 |
| K151907 | ZIMMER, INC. | Cable-Ready« Cable Grip System: Cable-Ready« GTR System, Cable-Ready« 1.8mm Cerclage Cables | 12/30/2015 |
| K152484 | ZIMMER, INC. | FastFrame External Fixation System - Distal Radius | 12/04/2015 |
| K151992 | ZIMMER, INC. | FastFrame External Fixation System - Knee Spanning, FastFrame External Fixation System - Damage Control | 11/02/2015 |
| K152755 | Zimmer, Inc. | FastFrame External Fixation System-Ankle Spanning | 12/21/2015 |
| K954555 | ZIMMER, INC. | VERSA-FX FEMORAL FIXATION SYSTEM | 01/26/1996 |
| K150818 | ZIMMER, INC. | Versa-Fx Femoral Fixation System, Versa-Fx II Femoral Fixation System, Free-Lock Femoral Fixation System | 05/01/2015 |
| K042761 | ZIMMER, INC. | WRISTORE DISTAL RADIUS FRACTURE FIXATOR, 4600 SERIES | 11/17/2004 |
| K141697 | ZIMMER, INC. | XTRAFIX EXTERNAL FIXATION SYSTEM, XTRAFIX SMALL EXTERNAL FIXATION SYSTEM | 09/18/2014 |
| K131413 | ZIMMER, INC. | XTRAFIX SMALL EXTERNAL FIXATION SYSTEM | 01/28/2014 |
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