FDA product code KTW: Appliance, Fixation, Nail/Blade/Plate Combination, Single Component
KTW is the FDA product code for appliance, fixation, nail/blade/plate combination, single component. It is a Class II device, regulated under 21 CFR 888.3030 and reviewed by the Orthopedic panel. FDA has cleared 38 510(k) submissions under KTW, from 25 different applicants. The average 510(k) review took 88 days (median 64). FDA has posted 57 recalls for KTW devices.
Classification
| Field | Value |
|---|---|
| Device name | Appliance, Fixation, Nail/Blade/Plate Combination, Single 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 KTW
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 2 | 62 |
| 2019 | 1 | 301 |
Compare with all 510(k) review times · Search every KTW clearance
Top KTW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Synthes (Usa) | 8 | 2008-03-20 |
| Advanced Orthopaedic Solutions, Inc. | 2 | 2016-03-15 |
| Orthofix Srl | 2 | 2012-09-20 |
| Turnkey Intergration USA, Inc. | 2 | 1999-06-29 |
| Buckman Co., Inc. | 2 | 1989-11-03 |
20 more applicants have KTW clearances. See the full list in Caduvo.
Most recent KTW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K182285 | Paonan Biotech Co., Ltd. | PK High Tibial Osteotomy Correction System | 2019-06-20 | 301 |
| K171606 | Advanced Orthopaedic Solutions, Inc. (Aos) | AOS Anterolateral Proximal Humeral Plate | 2017-06-22 | 21 |
| K170693 | Paragon 28, Inc. | Phantom Small Bone Intramedullary Nail System | 2017-06-19 | 104 |
| K160409 | Advanced Orthopaedic Solutions, Inc. | AOS Anterolateral Proximal Humeral Plate | 2016-03-15 | 28 |
| K122541 | Orthofix Srl | ORTHOFIX CONTOURS PROIMAL HUMERAL PLATE (PHP) | 2012-09-20 | 30 |
Recalls for KTW devices
57 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2010-10-27.
Frequently asked questions
What is FDA product code KTW?
KTW is the FDA product code for appliance, fixation, nail/blade/plate combination, single component. It is a Class II device, regulated under 21 CFR 888.3030 and reviewed by the Orthopedic panel.
What device class is KTW?
Class II, regulation 21 CFR 888.3030. Typical premarket route: 510(k).
How long does a 510(k) take for product code KTW?
Across 38 cleared submissions the average was 88 days from receipt to decision (median 64).
Which companies have the most KTW clearances?
Synthes (Usa) (8); Advanced Orthopaedic Solutions, Inc. (2); Orthofix Srl (2); Turnkey Intergration USA, Inc. (2); Buckman Co., Inc. (2).
Have KTW devices been recalled?
Yes: 57 product recalls across 1 recall events; the most recent began 2010-10-27.
Next steps
- Run an FDA pathway report with predicate devices for product code KTW
- Run a recall and safety report across every KTW manufacturer
- Watch product code KTW 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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