ARIX Ankle Distal Tibia System
FDA 510(k) K231887 · Jeil Medical Corporation
510(k) numberK231887
Submission
- Device name
- ARIX Ankle Distal Tibia System
- Applicant
- Jeil Medical Corporation
Seoul, KR - Received
- June 27, 2023
- Decision date
- December 14, 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
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|---|---|---|---|
| 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 |
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|---|---|---|
| K252246 | Leforte MMF SystemJEY · Traditional | 04/02/2026SE |
| K252826 | ARIX Femur Nail SystemHSB · Traditional | 12/10/2025SE |
| K251431 | FIX-C PEEK ACIF SA SystemOVE · Traditional | 06/27/2025SE |
| K243973 | FIX-L PEEK PLIF and T-PLIF SystemMAX · Traditional | 06/12/2025SE |
| K242751 | ARIX Pectus Bar SystemHRS · Traditional | 05/30/2025SE |
| K242247 | ARIX Femur Nail SystemHSB · Traditional | 04/22/2025SE |
| K243915 | FIX-C 3D Ti ACIF SystemODP · Traditional | 02/18/2025SE |
| K243004 | Xpine Spinal Fixation SystemNKB · Traditional | 11/08/2024SE |
| K231251 | FlexWing Anterior Cervical Plate SystemKWQ · Traditional | 07/24/2024SE |
| K233912 | ARIX Cannulated Screw SystemHWC · Traditional | 03/11/2024SE |
Questions and answers
When was ARIX Ankle Distal Tibia System cleared by the FDA?
ARIX Ankle Distal Tibia System (K231887) received a 510(k) decision of Substantially Equivalent on December 14, 2023, 170 days after the submission was received.
What is the product code of K231887?
The FDA product code is HRS – Plate, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3030.