APTUS Shoulder Proximal Humerus System, PentaLock 3.5
FDA 510(k) K253916 · Medartis AG
510(k) numberK253916
Submission
- Device name
- APTUS Shoulder Proximal Humerus System, PentaLock 3.5
- Applicant
- Medartis AG
Basel, CH - Received
- December 8, 2025
- Decision date
- March 16, 2026
- 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 |
|---|---|---|
| K260761 | APTUS Clavicle System 2.8HRS · Traditional | 06/05/2026SE |
| K260934 | TITAN Nail; APTUS K-Wire SystemHWC · Special | 04/17/2026SE |
| K243610 | APTUS Hand System; APTUS Elbow Dorsal OlecranonHRS · Traditional | 03/07/2025SE |
| K240613 | APTUS Elbow Dorsal Olecranon PlatesHRS · Traditional | 06/20/2024SE |
| K232105 | APTUS Foot System 2.8-3.5HRS · Traditional | 04/19/2024SE |
| K234062 | APTUS Hand Scaphoid PlatesHRS · Traditional | 03/21/2024SE |
| K232251 | APTUS Cannulated Compression Screws Line Extension, APTUS K-Wire System Line ExtensionHWC · Traditional | 11/03/2023SE |
| K232324 | StealthFix Intraosseous Fixation SystemJDR · Special | 08/30/2023SE |
| K232144 | Sterile Products of the APTUS SystemHRS · Special | 08/18/2023SE |
| K230971 | APTUS® 3.5 TriLock Straight PlatesHRS · Traditional | 06/02/2023SE |
Questions and answers
When was APTUS Shoulder Proximal Humerus System, PentaLock 3.5 cleared by the FDA?
APTUS Shoulder Proximal Humerus System, PentaLock 3.5 (K253916) received a 510(k) decision of Substantially Equivalent on March 16, 2026, 98 days after the submission was received.
What is the product code of K253916?
The FDA product code is HRS – Plate, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3030.