# K802123: Monospherical Shoulder Prosthesis

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Corp.
- Decided: Sep 16, 1980 after 12 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.
415 later devices descend from it; 1 cites it directly.
1 of 416 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K991585: Bipolar Shoulder Prosthesis (1999), 414 descendants of its own
- K021478: Delta Shoulder (2003), 338 descendants of its own
- K062116: Delta Cta Reverse Shoulder System Humeral Heads (2006), 295 descendants of its own
- K030941: Aequalis Reversed Shoulder Prosthesis (2004), 280 descendants of its own
- K041873: Aequalis Reversed Shoulder Prosthesis (2004), 277 descendants of its own

Source page: https://510kreport.com/device/K802123
Methodology: https://510kreport.com/methodology