# K113254: SMR Modular Glenoid-Metal-Back SMR Modular Glenoid-Liner SMR Modular Glenoid-Bone Screws

- Pathway: 510(k) (Traditional)
- Applicant: Lima Corporate S.P.A.
- Decided: Feb 24, 2012 after 113 days
- Product code: PHX (Shoulder Prosthesis, Reverse Configuration)
- 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: 10 generations back to K911686 (1991). 51 ancestors in all.
31 later devices descend from it; 6 cite it directly.
0 of 83 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110598: SMR Reverse Shoulder System, Lima Corporate S.P.A. (2011) Summary page 5.
- K100858: Lima-Lio SMR Shoulder System - Humeral Stems, Lima-Lio SMR Shoulder System - Humeral Bodies,, Lima-Lto S.P.A. (2010) Summary page 5.
- 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 5.
- K110847: SMR Shoulder System - Cta Humeral Heads, Lima Corporate S.P.A. (2011) Summary page 5.
- K111212: SMR Shoulder System- Revision Stems, Lima Corporate S.P.A. (2011) Summary page 5.
- K030710: Bio-Modular Shoulder System, Biomet, Inc. (2003) Summary page 5.
- K992119: Bio-Modular Shoulder System, Biomet, Inc. (1999) Summary page 5.
- K081448: Encore Shoulder Revision Glenoid, Encore Medical L.P. (2008) Summary page 5.

## Most influential descendants
- K133349: SMR TT Metal Back Glenoid (2014), 20 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
- K163397: SMR Hybrid Glenoid System (2017), 12 descendants of its own
- K200171: SMR TT Augmented Glenoid System (2020), 11 descendants of its own

## Indications for use
The SMR Modular Glenoid is intended for use in total primary or revision shoulder joint replacement with either the SMR Anatomic Shoulder System or the SMR Reverse Shoulder system. The SMR Anatomic Shoulder System 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; « Revision of a failed primary implant; . Cuff tear arthropathy (CTA Heads only); In the US, the SMR Metal Backed Glenoid/Liner construct, used as part of the SMR Anatomic Shoulder Replacement, is intended for use with bone cement and should be used without bone SCIEWS. : The SMR Reverse Shoulder System is indicated for primary, fracture or revision total shoulder replacement in a grossly rotator cuff deficient joint with severe arthropathy (disabling . shoulder). The patient's joint must be anatomically and structurally suited to receive the selected implants and a functional deltoid muscle is necessary to use the device. The SMR Metal Backed Glenoid/Connector/Glenosphere construct, used as part of the SMR Reverse Shoulder replacement, is intended for uncemented use with the addition of screws for fixation.

Source page: https://510kreport.com/device/K113254
Methodology: https://510kreport.com/methodology