AOS Calcaneal Plating System
FDA 510(k) K182466 · Advanced Orthopaedic Solutions
510(k) numberK182466
Submission
- Device name
- AOS Calcaneal Plating System
- Applicant
- Advanced Orthopaedic Solutions
Torrance, CA, US - Received
- September 10, 2018
- Decision date
- October 30, 2018
- 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 |
|---|---|---|
| K202489 | AOS Fibonacci Lower Extremity Plating System AOS Proximal Tibia Plating SystemHRS · Traditional | 10/26/2020SE |
| K202099 | AOS Galileo Trochanteric Nail SystemHSB · Special | 08/28/2020SE |
| K191598 | AOS ES Retrograde Femoral NailHSB · Special | 07/18/2019SE |
| 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 Calcaneal Plating System cleared by the FDA?
AOS Calcaneal Plating System (K182466) received a 510(k) decision of Substantially Equivalent on October 30, 2018, 50 days after the submission was received.
What is the product code of K182466?
The FDA product code is HRS – Plate, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3030.