# K063578: Promos Modular Shoulder System

- Pathway: 510(k) (Traditional)
- Applicant: Plus Orthopedics AG
- Decided: Mar 2, 2007 after 92 days
- Product code: HSD (Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3690
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K990137 (1999). 6 ancestors in all.
67 later devices descend from it; 6 cite it directly.
0 of 74 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032126: Promos Shoulder, Plus Orthopedics (2004) Summary page 1.

## Most influential descendants
- 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
- K100858: Lima-Lio SMR Shoulder System - Humeral Stems, Lima-Lio SMR Shoulder System - Humeral Bodies, (2010), 37 descendants of its own
- K110847: SMR Shoulder System - Cta Humeral Heads (2011), 34 descendants of its own

## Recalls of this device
- Jan 14, 2010 · Not classified · Z-1239-2010: Firm received complaints of Inclination Set Screws fracturing.
- Jan 14, 2010 · Not classified · Z-1241-2010: Firm received complaints of Inclination Set Screws fracturing.
- Jan 14, 2010 · Not classified · Z-1240-2010: Firm received complaints of Inclination Set Screws fracturing.
- Jan 14, 2010 · Not classified · Z-1242-2010: Firm received complaints of Inclination Set Screws fracturing.

## Indications for use
The PROMOS Modular Shoulder System is indicated for: · Advanced degeneration of the shoulder joint as a result of degenerative, post-traumatic or inflammatory arthritis * Avascular necrosis of the humeral head * Complex fractures of the proximal humerus * Functional impairment especially in the case of post-traumatic loss of the joint configuration 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/K063578
Methodology: https://510kreport.com/methodology