Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
KTT — Predicate Candidate Screening
404 FDA 510(k) clearances under this product code; the 50 most recent screened below.
75 daysmedian FDA review time
246 days90th percentile
404clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K254087 | MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction Sy | Synthes (USA) Products, LLC | 2026-06-11 | 175 | 0 |
| K260900 | DYNEX® External Fixation Systems | Vilex, LLC | 2026-04-17 | 30 | 0 |
| K260112 | QuikFix External Fixator: Knee-Spanning Pack | Stabiliz Orthopaedics, Inc. | 2026-03-23 | 68 | 0 |
| K253291 | Excelsior System | Blue Ocean Global | 2026-01-20 | 113 | 0 |
| K253202 | Hoffmann LRF System | Stryker GmbH | 2025-12-19 | 84 | 0 |
| K253613 | Monkey Rings External Ring Fixation System | Paragon 28, Inc. | 2025-12-19 | 31 | 0 |
| K252555 | Medusa Orthopedics Boa External Fixation System | Medusa Orthopedics, LLC | 2025-11-25 | 104 | 0 |
| K252625 | The Response Ortho Smart Fixator - Hexapod System | Response Ortho Solutions, LLC | 2025-11-20 | 93 | 0 |
| K252106 | External Fixation Mini Rail System | Paragon 28, Inc. | 2025-09-30 | 89 | 0 |
| K251862 | External Fixation Bone Distractor | Paragon 28, Inc. | 2025-08-11 | 55 | 0 |
| K250472 | SixFix™ Hexapod Fixator and Deformity Analysis and Correctio | Amdt Holdings, Inc. | 2025-08-08 | 171 | 0 |
| K251128 | Extremity Medical External Fixation System | Extremity Medical, LLC | 2025-05-07 | 26 | 0 |
| K243798 | Orthex External Fixation System | OrthoPediatrics Corp. | 2025-03-07 | 86 | 0 |
| K241563 | Extremity Medical External Fixation System | Extremity Medical, LLC | 2025-02-21 | 266 | 0 |
| K242861 | TrueLok Elevate | Orthofix Srl | 2024-12-03 | 74 | 0 |
| K242452 | Monkey Bars Pin to Bar External Fixation System | Paragon 28, Inc. | 2024-11-01 | 74 | 0 |
| K241769 | Response Ortho Metaphyseal Hinge Fixator System | Response Ortho Solutions, LLC | 2024-09-18 | 90 | 0 |
| K233025 | Revolution External Plating System | New Standard Device Dba Metalogix | 2024-05-30 | 251 | 0 |
| K240049 | LINK(TM) External Fixator | Metric Medical Devices, Inc. | 2024-05-29 | 142 | 0 |
| K233741 | Hoffmann LRF System | Stryker GmbH | 2023-12-21 | 29 | 0 |
| K221787 | Auxein's DHS/DCS Plate System | Auxein Medical Private Limited | 2023-11-30 | 527 | 0 |
| K232897 | Arthrex Small External Fixation System | Arthrex, Inc. | 2023-10-18 | 30 | 0 |
| K232838 | Monkey RingsTM External Fixation System | Paragon 28, Inc. | 2023-10-12 | 28 | 0 |
| K231922 | DEPUY SYNTHES MAXFRAME AUTOSTRUT System | DePuy Synthes | 2023-07-26 | 27 | 0 |
| K231461 | Smart Correction System (HA Half Pins) | Wishbone Medical, Inc. | 2023-06-16 | 28 | 0 |
| K223786 | Orthex External Fixation System | OrthoPediatrics Corp. | 2023-02-10 | 53 | 0 |
| K213905 | ONX Large External Fixation System | Orthonovis, Inc. | 2022-08-25 | 254 | 0 |
| K221366 | Smart Correction System Rings and Compatible HA-Coated Half | Wishbone Medical, Inc. | 2022-06-06 | 25 | 0 |
| K220809 | Drive Rail System | OrthoPediatrics Corp. | 2022-04-08 | 18 | 0 |
| K212895 | Paragon 28 External Ring Fixation System | Paragon 28, Inc. | 2021-11-08 | 59 | 0 |
| K212044 | TrueLok Evo | Orthofix Srl | 2021-11-05 | 128 | 0 |
| K212552 | Correx Software | Vilex, LLC | 2021-10-12 | 60 | 0 |
| K210953 | SMART Taylor Spatial Frame | Smith & Nephew, Inc. | 2021-07-29 | 121 | 0 |
| K211313 | MAXFRAME Multi-Axial Correction System (aka MAXFRAME) | Synthes (USA) Products, LLC | 2021-05-25 | 25 | 0 |
| K211112 | OIC External Fixation System | Orthopaedic Implant Company | 2021-05-05 | 21 | 0 |
| K203568 | Hoffmann LRF System | Stryker GmbH | 2021-02-01 | 56 | 0 |
| K202833 | Sequel External Fixation Device | Sequel Medical, Inc. | 2021-01-19 | 116 | 0 |
| K202810 | AutoStrut G2 | Orthospin, Ltd. | 2021-01-06 | 105 | 0 |
| K200491 | Bfix Orthopedic External Fixator Systems | Aike (Shanghai) Medical Instrument Co., Ltd. | 2021-01-05 | 312 | 0 |
| K201253 | Modular Rail System, TAYLOR SPATIAL FRAME External Fixator, | Smith & Nephew | 2020-12-08 | 211 | 0 |
| K202762 | Circular Fixation with Balanced Cable Transport | Smith & Nephew, Inc. | 2020-11-16 | 56 | 0 |
| K200728 | Pitkar DeftFix System | S.H.Pitkar Orthotools Pvt. , Ltd. | 2020-10-06 | 200 | 0 |
| K200123 | Accessories for the SixFix® Hexapod Fixator | Arrowhead De, LLC | 2020-09-22 | 245 | 0 |
| K193368 | Smart Correction System | Wishbone Medical, Inc. | 2020-09-18 | 288 | 1 |
| K200343 | FusionFrame Ring Lock System | Glw Medical Innovation | 2020-09-14 | 216 | 0 |
| K202143 | Dynex Micro | Vilex, LLC | 2020-09-11 | 42 | 0 |
| K202054 | Dynex Ring Fixation System, Diametrix Ring Fixation System | Vilex, LLC | 2020-08-24 | 31 | 0 |
| K200518 | Pitkar External Fixation System - Rail Mechanism | S.H.Pitkar Orthotools Pvt. , Ltd. | 2020-07-29 | 149 | 0 |
| K192181 | PRECICE Plating System | Nuvasive Specialized Orthopedics, Inc. | 2019-11-07 | 87 | 1 |
| K190486 | Pitkar External Fixation System | S.H.Pitkar Orthotools Pvt. , Ltd. | 2019-10-16 | 230 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda