FDA product code KTT: Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
KTT is the FDA product code for appliance, fixation, nail/blade/plate combination, multiple component. It is a Class II device, regulated under 21 CFR 888.3030 and reviewed by the Orthopedic panel. FDA has cleared 404 510(k) submissions under KTT, 29 in the last five years, from 154 different applicants. The average 510(k) review took 107 days (median 75); 107 days on average over the last three years. FDA has posted 89 recalls for KTT devices, 17 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component |
| Device class | Class II |
| Regulation | 21 CFR 888.3030 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for KTT
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 11 | 175 |
| 2018 | 6 | 143 |
| 2019 | 8 | 166 |
| 2020 | 9 | 160 |
| 2021 | 10 | 100 |
| 2022 | 3 | 99 |
| 2023 | 7 | 103 |
| 2024 | 5 | 126 |
| 2025 | 10 | 100 |
| 2026 | 4 | 96 |
Compare with all 510(k) review times · Search every KTT clearance
Top KTT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Ebi, L.P. | 35 | 2009-12-01 |
| Synthes (Usa) | 31 | 2010-05-11 |
| Howmedica Corp. | 20 | 1996-06-13 |
| Howmedica Osteonics Corp. | 19 | 2009-10-08 |
| Smith & Nephew, Inc. | 15 | 2021-07-29 |
149 more applicants have KTT clearances. See the full list in Caduvo.
Most recent KTT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K254087 | Synthes (USA) Products, LLC | MAXFRAME AUTOSTRUT with Bluetooth Multi-Axial Correction System | 2026-06-11 | 175 |
| K260900 | Vilex, LLC | DYNEX® External Fixation Systems | 2026-04-17 | 30 |
| K260112 | Stabiliz Orthopaedics, Inc. | QuikFix External Fixator: Knee-Spanning Pack | 2026-03-23 | 68 |
| K253291 | Blue Ocean Global | Excelsior System | 2026-01-20 | 113 |
| K253613 | Paragon 28, Inc. | Monkey Rings External Ring Fixation System | 2025-12-19 | 31 |
Recalls for KTT devices
89 product recalls in 51 recall events; 17 initiated in the last five years and 21 still open. Most recent: 2026-07-01.
| Year | Recalls |
|---|---|
| 2017 | 5 |
| 2018 | 17 |
| 2019 | 4 |
| 2020 | 2 |
| 2021 | 2 |
| 2022 | 1 |
| 2023 | 2 |
| 2024 | 1 |
| 2025 | 1 |
| 2026 | 11 |
Frequently asked questions
What is FDA product code KTT?
KTT is the FDA product code for appliance, fixation, nail/blade/plate combination, multiple component. It is a Class II device, regulated under 21 CFR 888.3030 and reviewed by the Orthopedic panel.
What device class is KTT?
Class II, regulation 21 CFR 888.3030. Typical premarket route: 510(k).
How long does a 510(k) take for product code KTT?
Across 404 cleared submissions the average was 107 days from receipt to decision (median 75).
Which companies have the most KTT clearances?
Ebi, L.P. (35); Synthes (Usa) (31); Howmedica Corp. (20); Howmedica Osteonics Corp. (19); Smith & Nephew, Inc. (15).
Have KTT devices been recalled?
Yes: 89 product recalls across 51 recall events; the most recent began 2026-07-01.
Next steps
- Run an FDA pathway report with predicate devices for product code KTT
- Run a recall and safety report across every KTT manufacturer
- Watch product code KTT for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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