Phantom Small Bone Intramedullary Nail System
FDA 510(k) K170693 · Paragon 28, Inc.
510(k) numberK170693
Submission
- Device name
- Phantom Small Bone Intramedullary Nail System
- Applicant
- Paragon 28, Inc.
Englewood, CO, US - Received
- March 7, 2017
- Decision date
- June 19, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KTW – Appliance, Fixation, Nail/Blade/Plate Combination, Single Component
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3030
- Specialty
- Orthopedic
- Implant
- Yes
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|---|---|---|---|
| K182285 | PK High Tibial Osteotomy Correction SystemKTW · Traditional | Paonan Biotech Co., Ltd. | 06/20/2019SE |
| K171606 | AOS Anterolateral Proximal Humeral PlateKTW · Special | Advanced Orthopaedic Solutions, Inc. (Aos) | 06/22/2017SE |
| K160409 | AOS Anterolateral Proximal Humeral PlateKTW · Special | Advanced Orthopaedic Solutions, Inc. | 03/15/2016SE |
| K122541 | Orthofix Contours Proimal Humeral Plate (PHP)KTW · Special | Orthofix Srl | 09/20/2012SE |
| K080590 | Aos Proximal Humeral PlateKTW · Traditional | Advanced Orthopaedic Solutions, Inc. | 05/06/2008SE |
| K080109 | Synthes (USA) Modular Blade Plate SystemKTW · Traditional | Synthes (Usa) | 03/20/2008SE |
| K062920 | Orthofix Titanium Humeral Plating System LSPKTW · Traditional | Orthofix Srl | 11/13/2006SE |
| K023360 | Leforte System Bone PlateKTW · Traditional | Jeil Medical Corporation | 10/25/2002SE |
| K012645 | Reprocessed Ebi External Fixation DevicesKTW · Traditional | Alliance Medical Corp. | 06/24/2002SE |
| K012634 | Reprocessed External Fixation DeviceKTW · Traditional | Alliance Medical, Inc. | 06/24/2002SE |
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| K262722 | Primal K-Wire (P99-193-1410)HTY · Special | 08/28/2026SE |
| K261121 | Megalodon Dynamic Compression SystemJDR · Traditional | 08/06/2026SE |
| K262047 | Grappler Suture Anchor SystemMBI · Special | 08/03/2026SE |
| K253886 | Grappler Suture Anchor PCFD Tether SystemMBI · Traditional | 03/17/2026SE |
| K253591 | Phantom® Hindfoot TTC/TC Nail SystemHSB · Traditional | 03/05/2026SE |
| K253613 | Monkey Rings External Ring Fixation SystemKTT · Special | 12/19/2025SE |
| K252106 | External Fixation Mini Rail SystemKTT · Traditional | 09/30/2025SE |
| K251862 | External Fixation Bone DistractorKTT · Traditional | 08/11/2025SE |
| K250952 | Baby Gorilla®/Gorilla® Plating SystemHRS · Traditional | 07/18/2025SE |
| K251850 | Phantom® Hindfoot TTC/TC Nail SystemHSB · Special | 07/14/2025SE |
Questions and answers
When was Phantom Small Bone Intramedullary Nail System cleared by the FDA?
Phantom Small Bone Intramedullary Nail System (K170693) received a 510(k) decision of Substantially Equivalent on June 19, 2017, 104 days after the submission was received.
What is the product code of K170693?
The FDA product code is KTW – Appliance, Fixation, Nail/Blade/Plate Combination, Single Component, a Class II (moderate risk) device regulated under 21 CFR 888.3030.