Ankle Fusion Plating System
FDA 510(k) K173121 · In2bones Sas
510(k) numberK173121
Submission
- Device name
- Ankle Fusion Plating System
- Applicant
- In2bones Sas
Ecully, FR - Received
- September 29, 2017
- Decision date
- November 28, 2017
- 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 |
|---|---|---|
| K231699 | QUANTUM® Patient Specific Instrumentation (PSI) SystemHSN · Traditional | 04/23/2024SE |
| K230313 | QUANTUM Patient Specific Instrumentation (PSI) SystemHSN · Traditional | 04/06/2023SE |
| K211883 | QUANTUM® Patient Specific Instrumentation (PSI) SystemHSN · Traditional | 08/11/2021SE |
| K191380 | Quantum® Total Ankle ProsthesisHSN · Traditional | 01/29/2020SE |
| K173811 | TRIWAY Tibiotalocalcaneal (TTC) Arthrodesis SystemHSB · Traditional | 03/15/2018SE |
| K173616 | DIP Arthrodesis SystemHTY · Traditional | 01/19/2018SE |
| K170688 | PITStop® implantHWC · Traditional | 11/28/2017SE |
| K170594 | I.B.S. osteosynthesis screwsHWC · Special | 05/10/2017SE |
| K160174 | I.B.S. 2.0 Osteosynthesis screwHWC · Traditional | 10/06/2016SE |
| K160995 | NEOVIEW Plating SystemHRS · Traditional | 06/10/2016SE |
Questions and answers
When was Ankle Fusion Plating System cleared by the FDA?
Ankle Fusion Plating System (K173121) received a 510(k) decision of Substantially Equivalent on November 28, 2017, 60 days after the submission was received.
What is the product code of K173121?
The FDA product code is HRS – Plate, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3030.