RibFix Titan Fixation System
FDA 510(k) K241282 · Riverpoint Medical
510(k) numberK241282
Submission
- Device name
- RibFix Titan Fixation System
- Applicant
- Riverpoint Medical
Portland, OR, US - Received
- May 7, 2024
- Decision date
- August 19, 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
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| 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 |
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| K242494 | OsseoFit Interfacing Anchor; OsseoFit Bone Tunnel ConstructMBI · Traditional | 11/26/2024SE |
| K243323 | Iconix Knotless AnchorMBI · Special | 11/19/2024SE |
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Questions and answers
When was RibFix Titan Fixation System cleared by the FDA?
RibFix Titan Fixation System (K241282) received a 510(k) decision of Substantially Equivalent on August 19, 2024, 104 days after the submission was received.
What is the product code of K241282?
The FDA product code is HRS – Plate, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3030.