REDEMPTION Charcot Plating System
FDA 510(k) K233816 · Vilex, LLC
510(k) numberK233816
Submission
- Device name
- REDEMPTION Charcot Plating System
- Applicant
- Vilex, LLC
Mcminnville, TN, US - Received
- November 30, 2023
- Decision date
- August 28, 2024
- 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 |
|---|---|---|
| K260900 | DYNEX® External Fixation SystemsKTT · Special | 04/17/2026SE |
| K250304 | TITANEX Screw SystemsHWC · Special | 03/05/2025SE |
| K240475 | Hintermann Series H2 Total Ankle SystemHSN · Traditional | 12/02/2024SE |
| K243408 | TACTIX Vector Syndesmosis SystemHTN · Special | 11/27/2024SE |
| K240035 | TACTIX Vector Syndesmosis SystemHTN · Traditional | 08/01/2024SE |
| K231343 | Redemption Duo Hindfoot Nail SystemHSB · Traditional | 01/30/2024SE |
| K231504 | TITANEX MICROBEAM Screw System, TITANEX ARTEMIS Screw SystemHWC · Traditional | 09/11/2023SE |
| K231493 | NITINEX Memory Compression StapleJDR · Traditional | 08/11/2023SE |
| K230462 | OPTIX H2 Patient Specific Instrument SystemHSN · Traditional | 07/17/2023SE |
| K230204 | ALPHALOK Plating SystemHRS · Traditional | 04/25/2023SE |
Questions and answers
When was REDEMPTION Charcot Plating System cleared by the FDA?
REDEMPTION Charcot Plating System (K233816) received a 510(k) decision of Substantially Equivalent on August 28, 2024, 272 days after the submission was received.
What is the product code of K233816?
The FDA product code is HRS – Plate, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3030.