Megalodon Dynamic Compression System
FDA 510(k) K261121 · Paragon 28, Inc.
510(k) numberK261121
Submission
- Device name
- Megalodon Dynamic Compression System
- Applicant
- Paragon 28, Inc.
Centennial, CO, US - Received
- April 3, 2026
- Decision date
- August 6, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JDR – Staple, Fixation, Bone
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3030
- Specialty
- Orthopedic
- Implant
- Yes
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| K243658 | TMC Compression Implant SystemJDR · Special | Treace Medical Concepts | 12/26/2024SE |
| K242415 | TMC Compression Implant SystemJDR · Special | Treace Medical Concepts | 09/06/2024SE |
| K240212 | COGNiTiON Staple SystemJDR · Special | Ortho Solutions UK , Ltd. | 02/23/2024SE |
| K232990 | ATOMIC Nitinol Fixation SystemJDR · Traditional | Rmr Ortho, LLC | 01/12/2024SE |
| K230724 | arcad® 2.0 Duo & Quadro osteosynthesis compressive staplesJDR · Traditional | Novastep | 12/04/2023SE |
| K232905 | Medline UNITE® REFLEX® Nitinol Staple KitJDR · Special | Medline Industries, LP | 10/19/2023SE |
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| K251862 | External Fixation Bone DistractorKTT · Traditional | 08/11/2025SE |
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Questions and answers
When was Megalodon Dynamic Compression System cleared by the FDA?
Megalodon Dynamic Compression System (K261121) received a 510(k) decision of Substantially Equivalent on August 6, 2026, 125 days after the submission was received.
What is the product code of K261121?
The FDA product code is JDR – Staple, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3030.