# K111212: SMR Shoulder System- Revision Stems

- Pathway: 510(k) (Traditional)
- Applicant: Lima Corporate S.P.A.
- Decided: Jul 28, 2011 after 90 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: 5 generations back to K911686 (1991). 29 ancestors in all.
33 later devices descend from it; 4 cite it directly.
0 of 63 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100858: Lima-Lio SMR Shoulder System - Humeral Stems, Lima-Lio SMR Shoulder System - Humeral Bodies,, Lima-Lto S.P.A. (2010) Summary page 1.
- K101263: Lima-Lto SMR Shoulder System - Finned Humeral Stems, Lima-Lto SMR Shoulder System - Finned Humeral Bodies,, Lima-Lto S.P.A. (2011) Summary page 2.
- K984541: Global FX Humeral Stem, Global Advantage Humeral Head, DePuy Orthopaedics, Inc. (1999) Summary page 2.
- K030941: Aequalis Reversed Shoulder Prosthesis, Tornier (2004) Summary page 2.

## Most influential descendants
- K113254: SMR Modular Glenoid-Metal-Back SMR Modular Glenoid-Liner SMR Modular Glenoid-Bone Screws (2012), 31 descendants of its own
- K133349: SMR TT Metal Back Glenoid (2014), 20 descendants of its own
- K130642: SMR 3-Pegs Glenoids (2013), 14 descendants of its own
- K153722: SMR 3-Pegs Glenoids (2016), 13 descendants of its own
- K191746: SMR TT Augmented Glenoid System (2019), 12 descendants of its own

## Indications for use
The SMVR Revision Stems are indicated for the treatment of fractures or revision of a failed primary component in total or hemi-shoulder replacement. The components are intended for use in cemented and uncemented applications according to their labeled indication. Total or hemi-shoulder replacement is indicated for patients suffering from disability due to: Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis; Inflammatory degenerative joint disease such as rheumatoid arthritis; Treatment of acute fractures of the humeral head that cannot be treated with other fracture fixation methods Cuff tear arthropathy; Revision of a failed primary component.

Source page: https://510kreport.com/device/K111212
Methodology: https://510kreport.com/methodology