# K113012: Promos Modular Shoulder System

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Jan 5, 2012 after 86 days
- Product code: KWS (Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K990137 (1999). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063578: Promos Modular Shoulder System, Plus Orthopedics AG (2007) Summary page 1.
- K955767: Cofied Modular Shoulder System, Smith & Nephew Richards, Inc. (1996) Summary page 2.

## 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 * Avasctilar 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/K113012
Methodology: https://510kreport.com/methodology