# K032126: Promos Shoulder

- Pathway: 510(k) (Traditional)
- Applicant: Plus Orthopedics
- Decided: Jan 8, 2004 after 182 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
Longest line of descent: 1 generation back to K990137 (1999). 5 ancestors in all.
130 later devices descend from it; 5 cite it directly.
0 of 136 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010124: Arthrex Univers 30 Shoulder Prosthesis, Arthrex, Inc. (2001) Summary page 1.
- K990136: Anatomica Glenoid Component, Sulzer Orthopedics, Inc. (1999) Summary page 1.
- K990137: Anatomica Humeral Stem/Head Components, Sulzer Orthopedics, Inc. (1999) Summary page 1.
- K003801: Anatomical Press-Fit Humeral Stem, Sulzer Orthopedics, Inc. (2001) Summary page 1.
- K003832: Sulzer Orthopedics Anatomical Shoulder Cemented Humeral Stem, Sulzer Orthopedics, Inc. (2001) Summary page 1.

## Most influential descendants
- K042021: Exactech Equinoxe Shoulder System (2004), 71 descendants of its own
- K063578: Promos Modular Shoulder System (2007), 67 descendants of its own
- K081016: Smith & Nephew, Inc., Promos Reverse Shoulder System (2008), 52 descendants of its own
- K110598: SMR Reverse Shoulder System (2011), 44 descendants of its own
- K101263: Lima-Lto SMR Shoulder System - Finned Humeral Stems, Lima-Lto SMR Shoulder System - Finned Humeral Bodies, (2011), 38 descendants of its own

## Indications for use
The PROMOS® Shoulder is indicated for: * Advanced wear of the shoulder joint due to degenerative, post-traumatic or rheumatoid arthritis * Fracture or avascular necrosis of the humeral head * Post-traumatic loss of joint configuration, especially in the case of functional impairment * Humerus fracture The humeral component is intended for cemented or cementless use. The glenoid component is for use with bone cement only.

Source page: https://510kreport.com/device/K032126
Methodology: https://510kreport.com/methodology