FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇭 Switzerland
APTUS Shoulder Proximal Humerus System, PentaLock 3.5
K Number: K253916
·
Decision Mar 16, 2026
Classifications
1
FEI Numbers
519
Registration Numbers
519
Same Product Code
1313
Applicant Total
42
Review Days
98
Basic Information
- Device Name
- APTUS Shoulder Proximal Humerus System, PentaLock 3.5
- K Number
- K253916
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medartis AG
- Date Received
- December 8, 2025
- Decision Date
- March 16, 2026
- Product Code
- HRS
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| HRS | Plate, Fixation, Bone | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
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Other Clearances by Medartis AG
| K Number | Device Name | ||
|---|---|---|---|
| K260761 | APTUS Clavicle System 2.8 | Jun 5, 2026 | Substantially Equivalent |
| K260934 | TITAN Nail; APTUS K-Wire System | Apr 17, 2026 | Substantially Equivalent |
| K243610 | APTUS Hand System; APTUS Elbow Dorsal Olecranon | Mar 7, 2025 | Substantially Equivalent |
| K240613 | APTUS Elbow Dorsal Olecranon Plates | Jun 20, 2024 | Substantially Equivalent |
| K232105 | APTUS Foot System 2.8-3.5 | Apr 19, 2024 | Substantially Equivalent |
| K234062 | APTUS Hand Scaphoid Plates | Mar 21, 2024 | Substantially Equivalent |
| K232251 | APTUS Cannulated Compression Screws Line Extension, APTUS K-Wire System Line Extension | Nov 3, 2023 | Substantially Equivalent |
| K232144 | Sterile Products of the APTUS System | Aug 18, 2023 | Substantially Equivalent |
| K230971 | APTUS® 3.5 TriLock Straight Plates | Jun 2, 2023 | Substantially Equivalent |
| K223853 | Medartis APTUS® Ulna Plates | Mar 30, 2023 | Substantially Equivalent |