PRCT2
FDA 510(k) K143721 · Fx Solutions
510(k) numberK143721
Submission
- Device name
- PRCT2
- Applicant
- Fx Solutions
Viriat, FR - Received
- December 29, 2014
- Decision date
- August 27, 2015
- 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 |
|---|---|---|
| K163669 | Humeris ShoulderPHX · Traditional | 05/17/2017SE |
| K162455 | Humelock Reversed ShoulderPHX · Traditional | 01/17/2017SE |
| K150488 | Humelock II Reversible Shoulder SystemPHX · Traditional | 11/13/2015SE |
| K140071 | Humelock II Cemented Shoulder SystemKWT · Traditional | 07/28/2014SE |
| K130759 | Humelock II Cementless Shoulder SystemHSD · Traditional | 11/09/2013SE |
| K123814 | Humelock II Cemented Shoulder SystemKWT · Traditional | 08/13/2013SE |
| K111097 | Humelock Cemented Shoulder ProsthesisHSD · Traditional | 11/09/2011SE |
Questions and answers
When was PRCT2 cleared by the FDA?
PRCT2 (K143721) received a 510(k) decision of Substantially Equivalent on August 27, 2015, 241 days after the submission was received.
What is the product code of K143721?
The FDA product code is HRS – Plate, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3030.