arcad® 2.0 Duo & Quadro osteosynthesis compressive staples
FDA 510(k) K230724 · Novastep
510(k) numberK230724
Submission
- Device name
- arcad® 2.0 Duo & Quadro osteosynthesis compressive staples
- Applicant
- Novastep
Rennes, FR - Received
- March 16, 2023
- Decision date
- December 4, 2023
- 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
Other 510(k)s with product code JDR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262451 | Arthrex DynaNite StaplesJDR · Traditional | Arthrex, Inc. | 09/01/2026SE |
| K261121 | Megalodon Dynamic Compression SystemJDR · Traditional | Paragon 28, Inc. | 08/06/2026SE |
| K250712 | Linkt Compression Staple SystemJDR · Traditional | Trax Surgical | 05/14/2025SE |
| K243888 | Medline UNITE® REFLEX® Hybrid Nitinol Implant SystemJDR · Traditional | Medline Industries, LP | 04/11/2025SE |
| K243742 | Arthrex DynaNite Nitinol StaplesJDR · Traditional | Arthrex, Inc. | 01/31/2025SE |
| 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 |
| K232905 | Medline UNITE® REFLEX® Nitinol Staple KitJDR · Special | Medline Industries, LP | 10/19/2023SE |
More from Medline Industries, LP
| 510(k) | Device | Decision |
|---|---|---|
| K260274 | Airlock® Ankle Plating SystemHRS · Abbreviated | 03/25/2026SE |
| K223468 | Nexis® compressive screwsHWC · Abbreviated | 08/30/2023SE |
| K192356 | Airlock Centrolock Osteosynthesis Implant SystemHRS · Traditional | 12/14/2019SE |
| K151277 | Airlock® osteosynthesis plate systemHRS · Traditional | 08/13/2015SE |
| K143523 | Airlock osteosynthesis plate systemHRS · Traditional | 04/06/2015SE |
| K143049 | LYNC intramedullary implantHTY · Traditional | 02/19/2015SE |
| K143229 | Nexis osteosynthesis compressive screwsHWC · Traditional | 02/06/2015SE |
| K143146 | Nexis osteosynthesis snap-off screwsHWC · Traditional | 02/06/2015SE |
Questions and answers
When was arcad® 2.0 Duo & Quadro osteosynthesis compressive staples cleared by the FDA?
arcad® 2.0 Duo & Quadro osteosynthesis compressive staples (K230724) received a 510(k) decision of Substantially Equivalent on December 4, 2023, 263 days after the submission was received.
What is the product code of K230724?
The FDA product code is JDR – Staple, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3030.