# K161476: SMR Shoulder System

- Pathway: 510(k) (Special)
- Applicant: Lima Corporate S.P.A.
- Decided: Jun 24, 2016 after 28 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: 4 generations back to K873073 (1987). 16 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 18 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 7.

## Most influential descendants
- K210899: LINK Embrace Shoulder System- Anatomical Configuration (2021), 0 descendants of its own

## Indications for use
The SMR Shoulder System is intended for partial or total, primary or revision shoulder joint replacement. The SMR Anatomic Shoulder System is indicated for partial or total, primary or revision shoulder joint replacement in 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). 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 (disabled 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 Modular SMR Shoulder System allows the assembly of components in various humeral and glenoid constructs. The constructs are intended for cemented and uncemented use as specified in the following table. In the Anatomic shoulder the humeral construct consists of the humeral stem, the humeral body, the adaptor taper and the humeral head. In the Reverse shoulder the humeral construct consists of the humeral stem, the reverse humeral body and the reverse liner. On the humeral side the fixation of the humeral stem determines if the construct is cemented or uncemented. The Anatomic glenoid construct consists of an all polyethylene glenoid or a metal back assembled with a liner while the Reverse glenoid construct consists of the metal back, the connector and the glenosphere. On the glenoid side, the fixation of the all polyethylene glenoid or the metal back determines if the construct is cemented or uncemented. 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 screws. 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. The SMR TT Metal Back is indicated for primary implant in anatomic or reverse total shoulder arthroplasty with poor glenoid bone quality or in revision case with consistent bone loss on the glenoid side. The implant is suitable for implantation with or without bone graft. These indications are not yet approved in the US. In the US the SMR TT Metal Back Baseplate used as part of the SMR Anatomic Shoulder Replacement, is intended for use with bone cement and should be used without bone screws; while when used as part of the SMR Reverse Shoulder replacement, is intended for uncemented use with the addition of screws for fixation. The Dia. 50, 52 and 54 mm Humeral Heads with +3mm increased height cannot be coupled to the Long Adaptor Tapers (both concentric and eccentric) The Dia. 52 and 54 mm Humeral Heads with +2mm increased height cannot be coupled to the Long Adaptor Tapers (both concentric and eccentric)

Source page: https://510kreport.com/device/K161476
Methodology: https://510kreport.com/methodology