# K200171: SMR TT Augmented Glenoid System

- Pathway: 510(k) (Traditional)
- Applicant: Lima Corporate S.P.A.
- Decided: Nov 19, 2020 after 301 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: 15 generations back to K911686 (1991). 144 ancestors in all.
11 later devices descend from it; 2 cite it directly.
1 of 156 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191746: SMR TT Augmented Glenoid System, Lima Corporate S.P.A. (2019) Summary page 8.
- K191963: SMR Finned Short Stems, Lima Corporate S.P.A. (2019) Summary page 8.
- K161742: Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed Glenoid, Tornier, Inc. (2016) Summary page 8.
- K172502: Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate, Comprehensive Mini Baseplate, Biomet Manufacturing Corp (2018) Summary page 8.

## Most influential descendants
- K210717: Bone Screws dia. 5,0 mm (2021), 8 descendants of its own
- K220792: SMR Reverse Liner (2022), 7 descendants of its own
- K223876: SMR Shoulder System (2023), 3 descendants of its own
- K222427: PRIMA TT Glenoid (2022), 2 descendants of its own
- K243826: SMR Reverse HP Shoulder System (2025), 1 descendant 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. 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 all polyethylene glenoid, the polyethylene glenoid with metal peg or the metal back determines if the construct is cemented or uncemented.

Source page: https://510kreport.com/device/K200171
Methodology: https://510kreport.com/methodology