BioPro Foot Plating Systems
FDA 510(k) K162674 · Biopro, Inc.
510(k) numberK162674
Submission
- Device name
- BioPro Foot Plating Systems
- Applicant
- Biopro, Inc.
Port Huron, MI, US - Received
- September 26, 2016
- Decision date
- June 16, 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 |
|---|---|---|
| K163627 | Shotel Ankle Arthrodesis Nail SystemHSB · Traditional | 09/14/2017SE |
| K132510 | Biopro - Infinity Plate Anchor SystemHTN · Traditional | 10/24/2013SE |
| K130298 | Biopro Kwick-Wire Universal Screw SystemJDW · Traditional | 06/18/2013SE |
| K121973 | Biopro Hemi-Edge Toe SystemKWD · Traditional | 10/30/2012SE |
| K100761 | Biopro Polar HeadKWY · Traditional | 12/03/2010SE |
| K101030 | Modification to HBS Headless Bone ScrewHWC · Special | 06/03/2010SE |
| K090208 | Biopro Femoral HeadsJDI · Traditional | 05/22/2009SE |
| K083490 | Biopro K-Wire, Models 16863, 17231, 17232, 18577, 18682-18685HTY · Traditional | 03/18/2009SE |
| K082705 | Biopro Bipolar Head, Models 18130-18152KWY · Traditional | 12/15/2008SE |
| K081149 | Biopro Go-Ez ScrewHWC · Traditional | 08/05/2008SE |
Questions and answers
When was BioPro Foot Plating Systems cleared by the FDA?
BioPro Foot Plating Systems (K162674) received a 510(k) decision of Substantially Equivalent on June 16, 2017, 263 days after the submission was received.
What is the product code of K162674?
The FDA product code is HRS – Plate, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3030.