# K201905: SMR 140° Reverse Humeral Body

- Pathway: 510(k) (Traditional)
- Applicant: Lima Corporate S.P.A.
- Decided: Dec 17, 2020 after 161 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: 15 generations back to K911686 (1991). 148 ancestors in all.
No later device cites it as a predicate yet.
1 of 149 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191963: SMR Finned Short Stems, Lima Corporate S.P.A. (2019) Summary page 5.
- K041066: Encore Reverse Shoulder Prosthesis, Encore Medical L.P. (2005) Summary page 8.
- K051075: Encore Reverse Shoulder Prosthesis, Encore Medical L.P. (2005) Summary page 8.
- K092873: Reverse Shoulder Prosthesis, Djo Surgical (2009) Summary page 8.
- K112069: RSP Glenoid Baseplate Porous Coated, Encore Medical L.P. (2011) Summary page 8.
- K141006: RSP Humeral Socket Insert, Djo Global (2014) Summary page 8.

## 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. 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, a polyethylene glenoid with metal peg or a metal back assembled with a liner; the Reverse glenoid consists of a metal back/connector/glenosphere construct or of a peg/baseplate/glenosphere construct. On the glenoid side, the fixation of the all polyethylene glenoid, the polyethylene glenoid with metal peg or the metal back determines if the construct is cemented or uncemented. A= Anatomic / R=Reverse *NOTE: 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. SMR Lateralized Connectors are not indicated for use with glenoid bone grafting techniques. 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. 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. The Dia. 50, 52 and 54mm Humeral Heads with + 3mm increased height cannot be coupled to the Long Adaptor Tapers (both concentric and eccentric). The Dia. 52 and 54mm Humeral Heads with + 2mm increased height cannot be coupled to the Long Adaptor Tapers (both concentric and eccentric).

Source page: https://510kreport.com/device/K201905
Methodology: https://510kreport.com/methodology