FDA Product Code
FDA Product Code KTT — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Orthopedic
- 21 CFR Citation
- 888.3030
510(k) Clearances — 405 records · page 1 of 5
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K263083 | Response Ortho Smart Fixator - Hexapod System | Response Ortho Solutions, LLC | 2026-10-02 | Special | PDF ↗ |
| K254087 | MAXFRAME AUTOSTRUT with Bluetooth Multi-Axial Correction System | Synthes (USA) Products, LLC | 2026-06-11 | Traditional | PDF ↗ |
| K260900 | DYNEX® External Fixation Systems | Vilex, LLC | 2026-04-17 | Special | PDF ↗ |
| K260112 | QuikFix External Fixator: Knee-Spanning Pack | Stabiliz Orthopaedics, Inc. | 2026-03-23 | Traditional | PDF ↗ |
| K253291 | Excelsior System | Blue Ocean Global | 2026-01-20 | Traditional | PDF ↗ |
| K253613 | Monkey Rings External Ring Fixation System | Paragon 28, Inc. | 2025-12-19 | Special | PDF ↗ |
| K253202 | Hoffmann LRF System | Stryker GmbH | 2025-12-19 | Traditional | PDF ↗ |
| K252555 | Medusa Orthopedics Boa External Fixation System | Medusa Orthopedics, LLC | 2025-11-25 | Traditional | PDF ↗ |
| K252625 | The Response Ortho Smart Fixator - Hexapod System | Response Ortho Solutions, LLC | 2025-11-20 | Traditional | PDF ↗ |
| K252106 | External Fixation Mini Rail System | Paragon 28, Inc. | 2025-09-30 | Traditional | PDF ↗ |
| K251862 | External Fixation Bone Distractor | Paragon 28, Inc. | 2025-08-11 | Traditional | PDF ↗ |
| K250472 | SixFix Hexapod Fixator and Deformity Analysis and Correction Software (DACS) | Amdt Holdings, Inc. | 2025-08-08 | Traditional | PDF ↗ |
| K251128 | Extremity Medical External Fixation System | Extremity Medical, LLC | 2025-05-07 | Special | PDF ↗ |
| K243798 | Orthex External Fixation System | OrthoPediatrics Corp. | 2025-03-07 | Traditional | PDF ↗ |
| K241563 | Extremity Medical External Fixation System | Extremity Medical, LLC | 2025-02-21 | Traditional | PDF ↗ |
| K242861 | TrueLok Elevate | Orthofix Srl | 2024-12-03 | Traditional | PDF ↗ |
| K242452 | Monkey Bars Pin to Bar External Fixation System | Paragon 28, Inc. | 2024-11-01 | Traditional | PDF ↗ |
| K241769 | Response Ortho Metaphyseal Hinge Fixator System | Response Ortho Solutions, LLC | 2024-09-18 | Traditional | PDF ↗ |
| K233025 | Revolution External Plating System | New Standard Device Dba Metalogix | 2024-05-30 | Traditional | PDF ↗ |
| K240049 | LINK(TM) External Fixator | Metric Medical Devices, Inc. | 2024-05-29 | Traditional | PDF ↗ |
| K233741 | Hoffmann LRF System | Stryker GmbH | 2023-12-21 | Special | PDF ↗ |
| K221787 | Auxein's DHS/DCS Plate System | Auxein Medical Private Limited | 2023-11-30 | Traditional | PDF ↗ |
| K232897 | Arthrex Small External Fixation System | Arthrex, Inc. | 2023-10-18 | Special | PDF ↗ |
| K232838 | Monkey RingsTM External Fixation System | Paragon 28, Inc. | 2023-10-12 | Special | PDF ↗ |
| K231922 | DEPUY SYNTHES MAXFRAME AUTOSTRUT System | DePuy Synthes | 2023-07-26 | Special | PDF ↗ |
| K231461 | Smart Correction System (HA Half Pins) | Wishbone Medical, Inc. | 2023-06-16 | Special | PDF ↗ |
| K223786 | Orthex External Fixation System | OrthoPediatrics Corp. | 2023-02-10 | Traditional | PDF ↗ |
| K213905 | ONX Large External Fixation System | Orthonovis, Inc. | 2022-08-25 | Traditional | PDF ↗ |
| K221366 | Smart Correction System Rings and Compatible HA-Coated Half Pins | Wishbone Medical, Inc. | 2022-06-06 | Special | PDF ↗ |
| K220809 | Drive Rail System | OrthoPediatrics Corp. | 2022-04-08 | Special | PDF ↗ |
| K212895 | Paragon 28 External Ring Fixation System | Paragon 28, Inc. | 2021-11-08 | Traditional | PDF ↗ |
| K212044 | TrueLok Evo | Orthofix Srl | 2021-11-05 | Traditional | PDF ↗ |
| K212552 | Correx Software | Vilex, LLC | 2021-10-12 | Traditional | PDF ↗ |
| K210953 | SMART Taylor Spatial Frame | Smith & Nephew, Inc. | 2021-07-29 | Traditional | PDF ↗ |
| K211313 | MAXFRAME Multi-Axial Correction System (aka MAXFRAME) | Synthes (USA) Products, LLC | 2021-05-25 | Special | PDF ↗ |
| K211112 | OIC External Fixation System | Orthopaedic Implant Company | 2021-05-05 | Special | PDF ↗ |
| K203568 | Hoffmann LRF System | Stryker GmbH | 2021-02-01 | Traditional | PDF ↗ |
| K202833 | Sequel External Fixation Device | Sequel Medical, Inc. | 2021-01-19 | Traditional | PDF ↗ |
| K202810 | AutoStrut G2 | Orthospin, Ltd. | 2021-01-06 | Traditional | PDF ↗ |
| K200491 | Bfix Orthopedic External Fixator Systems | Aike (Shanghai) Medical Instrument Co., Ltd. | 2021-01-05 | Traditional | PDF ↗ |
| K201253 | Modular Rail System, TAYLOR SPATIAL FRAME External Fixator, JET-X Fixator, ILIZAROV External Fixator, Other External Fixation | Smith & Nephew | 2020-12-08 | Traditional | PDF ↗ |
| K202762 | Circular Fixation with Balanced Cable Transport | Smith & Nephew, Inc. | 2020-11-16 | Traditional | PDF ↗ |
| K200728 | Pitkar DeftFix System | S.H.Pitkar Orthotools Pvt. , Ltd. | 2020-10-06 | Traditional | PDF ↗ |
| K200123 | Accessories for the SixFix® Hexapod Fixator | Arrowhead De, LLC | 2020-09-22 | Traditional | PDF ↗ |
| K193368 | Smart Correction System | Wishbone Medical, Inc. | 2020-09-18 | Traditional | PDF ↗ |
| K200343 | FusionFrame Ring Lock System | Glw Medical Innovation | 2020-09-14 | Traditional | PDF ↗ |
| K202143 | Dynex Micro | Vilex, LLC | 2020-09-11 | Traditional | PDF ↗ |
| K202054 | Dynex Ring Fixation System, Diametrix Ring Fixation System | Vilex, LLC | 2020-08-24 | Traditional | PDF ↗ |
| K200518 | Pitkar External Fixation System - Rail Mechanism | S.H.Pitkar Orthotools Pvt. , Ltd. | 2020-07-29 | Traditional | PDF ↗ |
| K192181 | PRECICE Plating System | Nuvasive Specialized Orthopedics, Inc. | 2019-11-07 | Traditional | PDF ↗ |
| K190486 | Pitkar External Fixation System | S.H.Pitkar Orthotools Pvt. , Ltd. | 2019-10-16 | Traditional | PDF ↗ |
| K191241 | AutoStrut | Orthospin | 2019-08-14 | Traditional | PDF ↗ |
| K181630 | Revolution External Plating System | New Standard Device Dba Metalogix | 2019-05-29 | Traditional | PDF ↗ |
| K190069 | SixFix Hexapod Fixator and Deformity Analysis and Correction Software (DACS) | Arrowhead De, LLC | 2019-05-14 | Traditional | PDF ↗ |
| K183682 | OIC External Fixation System | Orthopaedic Implant Company | 2019-04-08 | Traditional | PDF ↗ |
| K181528 | Austin Miller Large External Fixation System | Austin Miller Trauma, LLC | 2019-02-28 | Traditional | PDF ↗ |
| K182968 | Hoffmann LRF System | Stryker GmbH | 2019-01-25 | Traditional | PDF ↗ |
| K182154 | Depuy Synthes Femoral Neck System | Synthes (USA) Products, LLC | 2018-10-16 | Traditional | PDF ↗ |
| K173883 | External Fixation System | Life Spine, Inc. | 2018-09-07 | Traditional | PDF ↗ |
| K180580 | Medline ReNewal Reprocessed Smith & Nephew Jet-X External Fixation Devices | Surgical Instrument Service and Savings, Inc. | 2018-07-27 | Traditional | PDF ↗ |
| K180832 | SALVATION External Fixation System | Wrightmedicaltechnologyinc | 2018-06-06 | Special | PDF ↗ |
| K172872 | DePuy Synthes Femoral Neck System | DePuy Synthes | 2018-03-05 | Traditional | PDF ↗ |
| K172438 | ARBOR External Fixation System | Globus Medical, Inc. | 2018-01-12 | Traditional | PDF ↗ |
| K171911 | Medline ReNewal Reprocessed Synthes External Fixation Systems | Surgical Instrument Service and Savings, Inc. | 2017-11-09 | Traditional | PDF ↗ |
| K170146 | Galaxy UNYCO System | Orthofix Srl | 2017-10-12 | Traditional | PDF ↗ |
| K170482 | Spider Frame External Fixation System | Tasarimmed Tibbi Mamuller Sanayi VE Ticaret A.S | 2017-09-27 | Traditional | PDF ↗ |
| K171211 | OIC External Fixation System | Orthopaedic Implant Company | 2017-09-27 | Traditional | PDF ↗ |
| K170704 | The Locking Pediatric Osteotomy Plate (LolliPOP) System | Pega Medical, Inc. | 2017-09-08 | Traditional | PDF ↗ |
| K163486 | DRACO Locking Bone Screws; DRACO Compression Screws; DRACO MetaFuse L Plates; DRACO MetaFuse BLP Plates; DRACO MetaFuse MTP Plates, Takú Plates, DuoTakú Plates, Open Wedge Plates, Osteoplate Plates, Plantar Plates, Calcaneus Offset Locking Plates | Hnm Total Recon, LLC | 2017-07-24 | Traditional | PDF ↗ |
| K170650 | Orthofix TrueLok Hexapod System (TL-HEX) V2.0 | Orthofix Srl | 2017-05-10 | Special | PDF ↗ |
| K163656 | Hoffmann LRF System | Stryker GmbH | 2017-04-14 | Traditional | PDF ↗ |
| K163323 | Dolphix® External Fixation System MR Conditional | Citieffe S.R.L. | 2017-03-20 | Traditional | PDF ↗ |
| K162033 | SALVATION External Fixation System | Wright Medical | 2017-03-06 | Traditional | PDF ↗ |
| K162032 | Arrowhead Mini-Rail Fixator | Arrowhead De, LLC | 2017-02-21 | Traditional | PDF ↗ |
| K160972 | Gexfix External Fixation | Gexfix International Corp. | 2016-12-28 | Traditional | PDF ↗ |
| K161753 | Hoffman LRF System | Stryker GmbH | 2016-11-15 | Traditional | PDF ↗ |
| K161417 | DePuy Synthes MAXFRAME Multi-Axial Correction System | Synthes USA, LLC | 2016-11-10 | Traditional | PDF ↗ |
| K160830 | Integra External Fixation System | Ascension Orthopedics | 2016-07-06 | Special | PDF ↗ |
| K153377 | Hoffmann LRF (Limb Reconstruction Frame) System | Stryker GmbH | 2016-04-11 | Traditional | PDF ↗ |
| K151881 | X-Fix Line Additions | Vilex IN Tennessee, Inc. | 2016-03-24 | Traditional | PDF ↗ |
| K151580 | D.N.E. External Fixation System | Dne, LLC | 2016-02-16 | Special | PDF ↗ |
| K153635 | SALVATION(R) External Fixation System | Wrightmedicaltechnologyinc | 2016-01-13 | Special | PDF ↗ |
| K153415 | Reprocessed Stryker External Fixation Devices | Stryker Sustainability Solutions | 2016-01-13 | Special | PDF ↗ |
| K153233 | Galaxy UNYCO System | Orthofix Srl | 2016-01-06 | Traditional | PDF ↗ |
| K151907 | Cable-Ready® Cable Grip System: Cable-Ready® GTR System, Cable-Ready® 1.8mm Cerclage Cables | Zimmer, Inc. | 2015-12-30 | Traditional | PDF ↗ |
| K152755 | FastFrame External Fixation System-Ankle Spanning | Zimmer, Inc. | 2015-12-21 | Traditional | PDF ↗ |
| K152484 | FastFrame External Fixation System - Distal Radius | Zimmer, Inc. | 2015-12-04 | Traditional | PDF ↗ |
| K150640 | RX-FIX Mini Rail External Fixator | Wrightmedicaltechnologyinc | 2015-12-01 | Traditional | PDF ↗ |
| K151992 | FastFrame External Fixation System - Knee Spanning, FastFrame External Fixation System - Damage Control | Zimmer, Inc. | 2015-11-02 | Traditional | PDF ↗ |
| K152171 | Orthofix TL-HEX True Lok Hexapod System (TL-HEX) V1.4 | Orthofix Srl | 2015-09-28 | Traditional | PDF ↗ |
| K152158 | ARIX Ankle System | Jeil Medical Corporation | 2015-09-28 | Traditional | PDF ↗ |
| K152045 | SALVATION® External Fixation System | Wrightmedicaltechnologyinc | 2015-08-21 | Special | PDF ↗ |
| K150818 | Versa-Fx Femoral Fixation System, Versa-Fx II Femoral Fixation System, Free-Lock Femoral Fixation System | Zimmer, Inc. | 2015-05-01 | Traditional | PDF ↗ |
| K150579 | Cardinal Health External Fixation System | Cardinalhealth | 2015-04-29 | Traditional | PDF ↗ |
| K150004 | SALVATION External Fixation System | Wrightmedicaltechnologyinc | 2015-03-04 | Traditional | PDF ↗ |
| K143220 | SIDEKICK EZ FRAME External Fixation System | Wrightmedicaltechnologyinc | 2015-01-08 | Traditional | PDF ↗ |
| K143125 | Orthofix True Lok Hexapod System VI.3 | Orthofix Srl | 2014-12-10 | Special | PDF ↗ |
| K141760 | ORTHOFIX GALAXY WRIST | Orthofix Srl | 2014-12-08 | Traditional | PDF ↗ |
| K142052 | ORTHOFIX GALAXY UNYCO DIAPHYSEAL TIBIA KIT | Orthofix Srl | 2014-12-05 | Traditional | PDF ↗ |
| K142520 | Smith & Nephew, Inc. Spatialframe.com V5.0 Web-based software | Smith & Nephew, Inc. | 2014-11-20 | Special | PDF ↗ |
Product code KTT · Class II · Orthopedic. Data: openFDA.