AOS Fibonacci Lower Extremity Plating System AOS Proximal Tibia Plating System
FDA 510(k) K202489 · Advanced Orthopaedic Solutions, Inc.
510(k) numberK202489
Submission
- Device name
- AOS Fibonacci Lower Extremity Plating System AOS Proximal Tibia Plating System
- Applicant
- Advanced Orthopaedic Solutions, Inc.
Torrance, CA, US - Received
- August 31, 2020
- Decision date
- October 26, 2020
- 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 |
|---|---|---|
| K202099 | AOS Galileo Trochanteric Nail SystemHSB · Special | 08/28/2020SE |
| K191598 | AOS ES Retrograde Femoral NailHSB · Special | 07/18/2019SE |
| K182466 | AOS Calcaneal Plating SystemHRS · Traditional | 10/30/2018SE |
| K160409 | AOS Anterolateral Proximal Humeral PlateKTW · Special | 03/15/2016SE |
| K143204 | AOS Clavicle Intramedullary DeviceHSB · Traditional | 06/03/2015SE |
| K141912 | Aos Small Bone External Fixation, Threaded Half Pins, Aos Small Bone External Fixation…KTT · Traditional | 10/29/2014SE |
| K141228 | Aos 6.5MM Captured, Fully Threaded Cancellous ScrewHSB · Traditional | 07/08/2014SE |
| K133081 | Trochanteric Nails and Es Trochanteric Nails, Humeral Naisl, Tibial Nails, Antegrade…HSB · Special | 12/31/2013SE |
| K132005 | Retrograde Femoral NailHSB · Traditional | 09/10/2013SE |
| K123569 | Antegrade Femoral NailHSB · Traditional | 05/24/2013SE |
Questions and answers
When was AOS Fibonacci Lower Extremity Plating System AOS Proximal Tibia Plating System cleared by the FDA?
AOS Fibonacci Lower Extremity Plating System AOS Proximal Tibia Plating System (K202489) received a 510(k) decision of Substantially Equivalent on October 26, 2020, 56 days after the submission was received.
What is the product code of K202489?
The FDA product code is HRS – Plate, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3030.