Solar 2 Anatomic Shoulder
510(k) K040432
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK040432 | Date7 Jan 2005 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- HSD
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3690
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Solar 2 Anatomic Shoulder is an anatomic artificial shoulder prosthesis system, classified as a shoulder joint replacement device. It is designed to replace the natural humeral head and/or glenoid component, providing pain relief and restoring joint function through anatomically accurate reconstruction. The system includes humeral components and heads with adjustable neck angles and varus/valgus variances to match patient-specific anatomy. Available in multiple diameters and heights, it is intended for use in total and hemi-arthroplasty procedures.
This device is supplied sterile and intended for single-use in orthopedic surgical settings. It is regulated under the FDA 510(k) pathway with a clearance type designated as Traditional, classified under product code HSD. The system is not labeled for MRI use and must be handled according to standard surgical protocols. Storage and handling instructions are provided by the manufacturer to maintain sterility and functionality prior to use.
Other devices from Stryker Orthopaedics
Questions
AI-generated answers, 1 Oct 2026
What is the Solar 2 Anatomic Shoulder Prosthesis System used for?
The Solar 2 Anatomic Shoulder Prosthesis System is designed to replace the natural humeral head and/or glenoid component in shoulder joint replacement surgeries. It provides pain relief and restores joint function through anatomically accurate reconstruction, making it suitable for both total and hemi-arthroplasty procedures. The adjustable neck angles and varus/valgus variances allow for customization to fit individual patient anatomy.
How is the Solar 2 Anatomic Shoulder Prosthesis System supplied?
The system is supplied sterile and intended for single-use in orthopedic surgical settings. This ensures safety and sterility during procedures, reducing the risk of infection and complications. The packaging and handling instructions are designed to maintain sterility and functionality until use.
Are there different sizes or models available for the Solar 2 Anatomic Shoulder?
Yes, the Solar 2 Anatomic Shoulder Prosthesis System includes humeral components and heads available in multiple diameters and heights. This variety allows surgeons to select the appropriate size to match the patient’s specific anatomy, ensuring a better fit and improved outcomes.
Can the Solar 2 Anatomic Shoulder Prosthesis System be reused?
No, the Solar 2 Anatomic Shoulder Prosthesis System is intended for single-use only. Single-use devices are designed to be used once and then discarded to maintain sterility and safety standards. Reusing medical devices can introduce risks of contamination and compromise patient safety.
What special considerations should be taken for storage and handling?
The Solar 2 Anatomic Shoulder Prosthesis System must be stored and handled according to the manufacturer’s instructions to maintain sterility and functionality. Proper storage conditions, such as keeping the device in its sealed packaging and avoiding exposure to moisture or contamination, are critical. Additionally, the system is not labeled for MRI use, so it should be handled with care to avoid any potential damage or interference with imaging equipment.