# K243826: SMR Reverse HP Shoulder System

- Pathway: 510(k) (Traditional)
- Applicant: Lima Corporate S.P.A.
- Decided: Jul 3, 2025 after 203 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: 19 generations back to K911686 (1991). 203 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 205 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K223876: SMR Shoulder System, Lima Corporate S.P.A. (2023) Summary page 6.

## Most influential descendants
- K252352: SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral System (2026), 0 descendants of its own

## Indications for use
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 SMR TT Hybrid Glenoid Reverse Baseplate must not be used in cases of excessive glenoid bone loss and/or when bone graft is needed. 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 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 Reverse glenoid consists of a metal back/connector/glenosphere construct or of a peg/baseplate/glenosphere construct. R=Reverse *NOTE: » When considering the humeral side, SMR Glenosphere @42 can be coupled only with PRIMA Humeral System. » 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. * SMR Lateralized Connectors are not indicated for use with glenoid bone grafting techniques. * In the US the SMR TT Metal Back Baseplate when used as part of the SMR Reverse Shoulder replacement, is intended for uncemented use with the addition of screws for fixation. If a SMR TT Hybrid Glenoid is in place and revision to a reverse prosthesis is required, the patient can be revised by removing the polyethylene baseplate, leaving the metal peg in place and by connecting it to the SMR TT Hybrid Glenoid Reverse Baseplate. The SMR TT Hybrid Glenoid Reverse Baseplate is intended for uncemented use with the addition of screws for fixation. * Glenosphere size must be chose according to clinical case, considering both joint dimension and soft tissues quality. In case of small shoulder join and/or stiff joint a smaller, surgeon should be prepared to use smaller glenosphere, such as 36 mm CoCrMo one.

Source page: https://510kreport.com/device/K243826
Methodology: https://510kreport.com/methodology