Primal K-Wire (P99-193-1410)
FDA 510(k) K262722 · Paragon 28, Inc.
510(k) numberK262722
Submission
- Device name
- Primal K-Wire (P99-193-1410)
- Applicant
- Paragon 28, Inc.
Centennial, CO, US - Received
- July 31, 2026
- Decision date
- August 28, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HTY – Pin, Fixation, Smooth
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3040
- Specialty
- Orthopedic
- Implant
- Yes
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| K231905 | Electro-Spec Steri-CapsHTY · Traditional | Electro-Spec, Inc. | 08/14/2023SE |
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| 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 |
| K250641 | APEX 3D Total Ankle Replacement SystemHSN · Traditional | 05/01/2025SE |
Questions and answers
When was Primal K-Wire (P99-193-1410) cleared by the FDA?
Primal K-Wire (P99-193-1410) (K262722) received a 510(k) decision of Substantially Equivalent on August 28, 2026, 28 days after the submission was received.
What is the product code of K262722?
The FDA product code is HTY – Pin, Fixation, Smooth, a Class II (moderate risk) device regulated under 21 CFR 888.3040.