# K040432: Solar 2 Anatomic Shoulder

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Orthopaedics
- Decided: Jan 7, 2005 after 323 days
- Product code: HSD (Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3690
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
The Javelin Shoulder is intended for use in total and hemi-arthroplasty of the shoulder. It is meant to replace the natural humeral head and/or glenoid to relieve pain and reconstruct the joint to re-establish as much normal joint function as possible. The humeral component is for cemented and uncemented use. The glenoid component is for cemented use only. The indications for use of the Javelin Shoulder when used as a total or hemi-shoulder include: * Aseptic necrosis of the humeral head. - Painful, disabling joint disease of the shoulder resulting from: degenerative arthritis, rheumatoid arthritis or post-traumatic arthritis. *Proximal humeral fracture and/or dislocation. Clinical management problems where arthrodesis or alternative reconstruction techniques are less likely to achieve satisfactory results. Additional indications for use as a total shoulder include: * Revision of previous unsuccessful total shoulder replacement, resurfacing or other procedure.

Source page: https://510kreport.com/device/K040432
Methodology: https://510kreport.com/methodology