ARIX Cannulated Screw System
FDA 510(k) K233912 · Jeil Medical Corporation
510(k) numberK233912
Submission
- Device name
- ARIX Cannulated Screw System
- Applicant
- Jeil Medical Corporation
Seoul, KR - Received
- December 12, 2023
- Decision date
- March 11, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HWC – Screw, Fixation, Bone
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3040
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code HWC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261057 | ActivaScrew Cannulated COMHWC · Traditional | Bioretec, Ltd. | 09/04/2026SE |
| K260106 | OsteoCoil GT Active Compression SystemHWC · Traditional | Flower Orthopedics Corporation DBA Conventus… | 08/24/2026SE |
| K262344 | Large Compression ScrewsHWC · Special | TriMed, Inc. | 08/12/2026SE |
| K253858 | GFS - Sterile Screws and Top HatHWC · Special | T.A.G. Medical Products Corporation, Ltd. | 08/05/2026SE |
| K262075 | Lapidus Screw KitHWC · Special | Relja Innovations, LLC | 07/22/2026SE |
| K260809 | Arthrex Sterile VAL and VAL KreuLock Compression Screw SystemHWC · Traditional | Arthrex, Inc. | 06/25/2026SE |
| K253108 | VEOFIX Snap Off ScrewHWC · Traditional | Steps Ortho | 06/05/2026SE |
| K261154 | CoLink® & CoLag® Non-Sterile ScrewsHWC · Special | In2Bones USA, LLC | 05/30/2026SE |
| K261241 | TriMed Compression ScrewsHWC · Special | TriMed, Inc. | 05/14/2026SE |
| K254215 | Arthrex Beaming SystemHWC · Traditional | Arthrex, Inc. | 05/08/2026SE |
More from Arthrex, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| 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 |
| K231887 | ARIX Ankle Distal Tibia SystemHRS · Traditional | 12/14/2023SE |
Questions and answers
When was ARIX Cannulated Screw System cleared by the FDA?
ARIX Cannulated Screw System (K233912) received a 510(k) decision of Substantially Equivalent on March 11, 2024, 90 days after the submission was received.
What is the product code of K233912?
The FDA product code is HWC – Screw, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3040.