DePuy Synthes Variable Angle Locking Patella Plating System
FDA 510(k) K210408 · Synthes (USA) Products, LLC
510(k) numberK210408
Submission
- Device name
- DePuy Synthes Variable Angle Locking Patella Plating System
- Applicant
- Synthes (USA) Products, LLC
West Chester, PA, US - Received
- February 11, 2021
- Decision date
- April 8, 2021
- 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 |
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| K212943 | SyntheCel Dura RepairGXQ · Traditional | 01/28/2022SE |
| K211313 | MAXFRAME Multi-Axial Correction System (aka MAXFRAME)KTT · Special | 05/25/2021SE |
| K210205 | DePuy Synthes 3.5/4.5 mm Variable Angle LCP Periprosthetic Proximal Femur Plating SystemHRS · Traditional | 03/26/2021SE |
| K201346 | DePuy Synthes Retrograde Femoral Nail Advanced System, DePuy Synthes Locking Screws for…HSB · Traditional | 09/23/2020SE |
| K192702 | DePuy Synthes Craniomaxillofacial Neuro Devices - MR ConditionalGXN · Traditional | 09/18/2020SE |
| K201944 | DePuy Synthes 2.4mm Ti Self-Tapping MatrixMANDIBLE Screws (26-40mm)JEY · Special | 09/10/2020SE |
| K201578 | DePuy Synthes Variable Angle Locking Patella Plating SystemHRS · Traditional | 09/09/2020SE |
| K201336 | DePuy Synthes Tibial Nail Advanced, Depuy Synthes Locking Screws Medullary Nails, 4.0…JDS · Traditional | 09/03/2020SE |
| K191463 | DePuy Synthes Hammertoe Continuous Compression ImplantJDR · Traditional | 02/26/2020SE |
Questions and answers
When was DePuy Synthes Variable Angle Locking Patella Plating System cleared by the FDA?
DePuy Synthes Variable Angle Locking Patella Plating System (K210408) received a 510(k) decision of Substantially Equivalent on April 8, 2021, 56 days after the submission was received.
What is the product code of K210408?
The FDA product code is HRS – Plate, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3030.