# K100858: Lima-Lio SMR Shoulder System - Humeral Stems, Lima-Lio SMR Shoulder System - Humeral Bodies,

- Pathway: 510(k) (Traditional)
- Applicant: Lima-Lto S.P.A.
- Decided: Dec 10, 2010 after 259 days
- Product code: KWT (Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3650
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K873073 (1987). 15 ancestors in all.
37 later devices descend from it; 9 cite it directly.
0 of 53 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 2.
- K030259: Amatomical Shoulder with Removable Head, Centerplus Orthopedics, Inc. (2003) Summary page 2.
- K992525: Acumed Modular Shoulder System, Acu Med, Inc. (2000) Summary page 2.

## Most influential descendants
- K110847: SMR Shoulder System - Cta Humeral Heads (2011), 34 descendants of its own
- K111212: SMR Shoulder System- Revision Stems (2011), 33 descendants of its own
- 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

## Recalls of this device
- Aug 14, 2015 · Class II · Z-2539-2015: The dimensions of the mating features of the recalled products are out of specification causing the device to be difficult to assemble.
- Aug 14, 2015 · Class II · Z-2540-2015: The dimensions of the mating features of the recalled products are out of specification causing the device to be difficult to assemble.

## Indications for use
The SMR Shoulder system is intended for partial or total primary shoulder joint replacement. The components are intended for use in cemented applications. 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

Source page: https://510kreport.com/device/K100858
Methodology: https://510kreport.com/methodology