# K101263: Lima-Lto SMR Shoulder System - Finned Humeral Stems, Lima-Lto SMR Shoulder System - Finned Humeral Bodies,

- Pathway: 510(k) (Traditional)
- Applicant: Lima-Lto S.P.A.
- Decided: Jan 28, 2011 after 268 days
- Product code: KWT (Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3650
- 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 K873073 (1987). 15 ancestors in all.
38 later devices descend from it; 9 cite it directly.
0 of 54 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 3.
- K063578: Promos Modular Shoulder System, Plus Orthopedics AG (2007) Summary page 3.
- K030259: Amatomical Shoulder with Removable Head, Centerplus Orthopedics, Inc. (2003) Summary page 3.
- K992525: Acumed Modular Shoulder System, Acu Med, Inc. (2000) Summary page 3.

## 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

## 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 and uncemented applications, as specified in the following table: 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/K101263
Methodology: https://510kreport.com/methodology