# K223876: SMR Shoulder System

- Pathway: 510(k) (Traditional)
- Applicant: Lima Corporate S.P.A.
- Decided: Feb 3, 2023 after 42 days
- Product code: MBF (Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3670
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 18 generations back to K911686 (1991). 202 ancestors in all.
3 later devices descend from it; 2 cite it directly.
1 of 206 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220792: SMR Reverse Liner, Lima Corporate S.P.A. (2022) Summary page 5.

## Most influential descendants
- K243826: SMR Reverse HP Shoulder System (2025), 1 descendant of its own
- K252352: SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral System (2026), 0 descendants of its own
- K231099: SMR Hybrid Glenoid System (2023), 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; in case of SMR Short Stems only if sufficient bone stock remains); • cuff tear arthropathy (CTA Heads only); • glenoid arthrosis without excessive glenoid bone loss: A1, A2 and B1 according to Walch classification (SMR TT Hybrid Glenoid 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 SMR TT Hybrid Glenoid Reverse Baseplate must not be used in cases of excessive glenoid bone loss and/or when bone graft is needed.

Source page: https://510kreport.com/device/K223876
Methodology: https://510kreport.com/methodology