MotoBAND CP Implant System: DynaBunion 4D Minimal-incision Bunion System, DynaMET Lesser TMT Fusion System
FDA 510(k) K223342 · Crossroads Extremity Systems, LLC
510(k) numberK223342
Submission
- Device name
- MotoBAND CP Implant System: DynaBunion 4D Minimal-incision Bunion System, DynaMET Lesser TMT Fusion System
- Applicant
- Crossroads Extremity Systems, LLC
Memphis, TN, US - Received
- November 1, 2022
- Decision date
- March 30, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HRS – Plate, Fixation, Bone
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3030
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code HRS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261647 | Tempo Plating System; Ultra Compression Screw SystemHRS · Traditional | Pace Surgical | 09/03/2026SE |
| K261830 | FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See…HRS · Traditional | Ortler Global Tibbi Gerecler Anonim Sirketi | 08/28/2026SE |
| K262537 | Versalock Sterile Plating SystemHRS · Special | GM Dos Reis Industria e Comercio Ltda. | 08/19/2026SE |
| K260277 | Mikron Trauma Bone Plate& Screw SystemHRS · Traditional | Mikron Makina San. ve Tic. Ltd. Sti. | 08/13/2026SE |
| K261511 | Xpert AnkleHRS · Traditional | Newclip Technics | 07/28/2026SE |
| K261406 | Versalock Proximal Tibial Plating SystemHRS · Traditional | GM Dos Reis Industria e Comercio Ltda. | 07/21/2026SE |
| K262032 | TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion…HRS · Special | TriMed, Inc. | 07/16/2026SE |
| K261191 | Alians Elbow SHRS · Traditional | Newclip Technics | 07/08/2026SE |
| K261054 | RibPlate SystemHRS · Traditional | Stryker Leibinger GmbH & Co KG | 07/01/2026SE |
| K261351 | SALGINA 2.5mm Distal Radius SystemHRS · Traditional | Bonebridge AG | 06/26/2026SE |
More from Bonebridge AG
| 510(k) | Device | Decision |
|---|---|---|
| K253178 | TRILEAP Plating SystemHRS · Traditional | 01/06/2026SE |
| K241050 | CrossRoads Modular Tray SystemKCT · Traditional | 07/16/2024SE |
| K230591 | TriLEAP Plating SystemHRS · Traditional | 09/29/2023SE |
| K220797 | FootHold SystemMBI · Traditional | 04/15/2022SE |
| K202268 | CrossRoads Tray SystemKCT · Traditional | 12/30/2020SE |
| K190658 | MIS Bunion Plating SystemHRS · Special | 04/12/2019SE |
| K181872 | MIS Bunion SystemHRS · Traditional | 02/19/2019SE |
| K181866 | MotoCLIP/HiMAX Step Staple Implant SystemJDR · Special | 08/09/2018SE |
| K181410 | MotoCLIP/HiMAX Implant SystemJDR · Special | 06/29/2018SE |
| K173710 | MotoBAND CP Implant SystemHWC · Special | 02/12/2018SE |
Questions and answers
When was MotoBAND CP Implant System: DynaBunion 4D Minimal-incision Bunion System, DynaMET Lesser TMT Fusion System cleared by the FDA?
MotoBAND CP Implant System: DynaBunion 4D Minimal-incision Bunion System, DynaMET Lesser TMT Fusion System (K223342) received a 510(k) decision of Substantially Equivalent on March 30, 2023, 149 days after the submission was received.
What is the product code of K223342?
The FDA product code is HRS – Plate, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3030.