# K110847: SMR Shoulder System - Cta Humeral Heads

- Pathway: 510(k) (Traditional)
- Applicant: Lima Corporate S.P.A.
- Decided: Jul 15, 2011 after 109 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: 4 generations back to K873073 (1987). 18 ancestors in all.
34 later devices descend from it; 4 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)
- 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 1.
- K000575: Global Advantage Extended Humeral Head, DePuy Orthopaedics, Inc. (2000) Summary page 3.

## 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 SMR CTA Humeral Heads are intended for use with cemented and uncemented SMR humeral body - humeral stem assemblies in total or hemi- shoulder joint arthroplasty. The Glenoid is intended for cemented use only. Total and hemi-shoulder replacement utilizing the CTA head 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.

Source page: https://510kreport.com/device/K110847
Methodology: https://510kreport.com/methodology