Panels › Orthopedic › Product code KTT · Class 2
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Regulation 888.3030
9510(k)s in 12 months (405 all time)
11recalls in 12 months (89 all time)
85recalls that name a 510(k)
Top companies in KTT
| Company | 510(k)s | Recalls |
|---|---|---|
| Ebi, L.P. | 36 | 2 |
| Synthes | 33 | 1 |
| Stryker Corp. | 11 | 15 |
| Orthofix Srl | 11 | 12 |
| Howmedica Corp. | 22 | 0 |
| Howmedica Osteonics Corp. | 19 | 1 |
| Zimmer, Inc. | 10 | 9 |
| Smith & Nephew | 16 | 0 |
| Wrightmedicaltechnologyinc | 11 | 0 |
| Alliance Medical Corp. | 9 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 16, 2019 | K190486 | Pitkar External Fixation System S.H.Pitkar Orthotools Pvt. , Ltd., IN | KTT |
| Aug 14, 2019 | K191241 | AutoStrut Orthospin, IL | KTT |
| May 29, 2019 | K181630 | Revolution External Plating System New Standard Device Dba Metalogix | KTT |
| May 14, 2019 | K190069 | SixFix Hexapod Fixator and Deformity Analysis and Correction Software (DACS) Arrowhead De, LLC | KTT |
| Apr 8, 2019 | K183682 | OIC External Fixation System Orthopaedic Implant Company | KTT |
| Feb 28, 2019 | K181528 | Austin Miller Large External Fixation System Austin Miller Trauma, LLC | KTT |
| Jan 25, 2019 | K182968 | Hoffmann LRF System Stryker GmbH | KTT |
| Oct 16, 2018 | K182154 | Depuy Synthes Femoral Neck System Synthes (USA) Products, LLC | KTT |
| Sep 7, 2018 | K173883 | External Fixation System Life Spine, Inc. | KTT |
| Jul 27, 2018 | K180580 | Medline ReNewal Reprocessed Smith & Nephew Jet-X External Fixation Devices Surgical Instrument Service and Savings, Inc. | KTT |
| Jun 6, 2018 | K180832 | SALVATION External Fixation System Wrightmedicaltechnologyinc | KTT |
| Mar 5, 2018 | K172872 | DePuy Synthes Femoral Neck System DePuy Synthes, CH | KTT |
| Jan 12, 2018 | K172438 | ARBOR External Fixation System Globus Medical, Inc. | KTT |
| Nov 9, 2017 | K171911 | Medline ReNewal Reprocessed Synthes External Fixation Systems Surgical Instrument Service and Savings, Inc. | KTT |
| Oct 12, 2017 | K170146 | Galaxy UNYCO System Orthofix Srl, IT | KTT |
| Sep 27, 2017 | K171211 | OIC External Fixation System Orthopaedic Implant Company | KTT |
| Sep 27, 2017 | K170482 | Spider Frame External Fixation System Tasarimmed Tibbi Mamuller Sanayi VE Ticaret A.S, TR | KTT |
| Sep 8, 2017 | K170704 | The Locking Pediatric Osteotomy Plate (LolliPOP) System Pega Medical, Inc., CA | KTT |
| Jul 24, 2017 | K163486 | DRACO Locking Bone Screws; DRACO Compression Screws; DRACO MetaFuse L Plates; DRACO MetaFuse BLP Plates; DRACO MetaFuse Hnm Total Recon, LLC | KTT |
| May 10, 2017 | K170650 | Orthofix TrueLok Hexapod System (TL-HEX) V2.0 Orthofix Srl, IT | KTT |
| Apr 14, 2017 | K163656 | Hoffmann LRF System Stryker GmbH | KTT |
| Mar 20, 2017 | K163323 | Dolphix® External Fixation System MR Conditional Citieffe S.R.L., IT | KTT |
| Mar 6, 2017 | K162033 | SALVATION External Fixation System Wright Medical | KTT |
| Feb 21, 2017 | K162032 | Arrowhead Mini-Rail Fixator Arrowhead De, LLC | KTT |
| Dec 28, 2016 | K160972 | Gexfix External Fixation Gexfix International Corp. | KTT |
| Nov 15, 2016 | K161753 | Hoffman LRF System Stryker GmbH | KTT |
| Nov 10, 2016 | K161417 | DePuy Synthes MAXFRAME Multi-Axial Correction System Synthes USA, LLC | KTT |
| Jul 6, 2016 | K160830 | Integra External Fixation System Ascension Orthopedics | KTT |
| Apr 11, 2016 | K153377 | Hoffmann LRF (Limb Reconstruction Frame) System Stryker GmbH | KTT |
| Mar 24, 2016 | K151881 | X-Fix Line Additions Vilex IN Tennessee, Inc. | KTT |
| Feb 16, 2016 | K151580 | D.N.E. External Fixation System Dne, LLC | KTT |
| Jan 13, 2016 | K153635 | SALVATION(R) External Fixation System Wrightmedicaltechnologyinc | KTT |
| Jan 13, 2016 | K153415 | Reprocessed Stryker External Fixation Devices Stryker Sustainability Solutions | KTT |
| Jan 6, 2016 | K153233 | Galaxy UNYCO System Orthofix Srl, IT | KTT |
| Dec 30, 2015 | K151907 | Cable-Ready® Cable Grip System: Cable-Ready® GTR System, Cable-Ready® 1.8mm Cerclage Cables Zimmer, Inc. | KTT |
| Dec 21, 2015 | K152755 | FastFrame External Fixation System-Ankle Spanning Zimmer, Inc. | KTT |
| Dec 4, 2015 | K152484 | FastFrame External Fixation System - Distal Radius Zimmer, Inc. | KTT |
| Dec 1, 2015 | K150640 | RX-FIX Mini Rail External Fixator Wrightmedicaltechnologyinc | KTT |
| Nov 2, 2015 | K151992 | FastFrame External Fixation System - Knee Spanning, FastFrame External Fixation System - Damage Control Zimmer, Inc. | KTT |
| Sep 28, 2015 | K152171 | Orthofix TL-HEX True Lok Hexapod System (TL-HEX) V1.4 Orthofix Srl, IT | KTT |
| Sep 28, 2015 | K152158 | ARIX Ankle System Jeil Medical Corporation, KR | KTT |
| Aug 21, 2015 | K152045 | SALVATION® External Fixation System Wrightmedicaltechnologyinc | KTT |
| May 1, 2015 | K150818 | Versa-Fx Femoral Fixation System, Versa-Fx II Femoral Fixation System, Free-Lock Femoral Fixation System Zimmer, Inc. | KTT |
| Apr 29, 2015 | K150579 | Cardinal Health External Fixation System Cardinalhealth | KTT |
| Mar 4, 2015 | K150004 | SALVATION External Fixation System Wrightmedicaltechnologyinc | KTT |
| Jan 8, 2015 | K143220 | SIDEKICK EZ FRAME External Fixation System Wrightmedicaltechnologyinc | KTT |
| Dec 10, 2014 | K143125 | Orthofix True Lok Hexapod System VI.3 Orthofix Srl, IT | KTT |
| Dec 8, 2014 | K141760 | ORTHOFIX GALAXY WRIST Orthofix Srl | KTT |
| Dec 5, 2014 | K142052 | ORTHOFIX GALAXY UNYCO DIAPHYSEAL TIBIA KIT Orthofix Srl | KTT |
| Nov 20, 2014 | K142520 | Smith & Nephew, Inc. Spatialframe.com V5.0 Web-based software Smith & Nephew, Inc. | KTT |
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