# K222427: PRIMA TT Glenoid

- Pathway: 510(k) (Traditional)
- Applicant: Lima Corporate S.P.A.
- Decided: Oct 6, 2022 after 56 days
- Product code: MBF (Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3670
- Recalls of this device: 3 (0 Class I)
- 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.
2 later devices descend from it; 2 cite 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)
- K220792: SMR Reverse Liner, Lima Corporate S.P.A. (2022) Summary page 4.
- K161742: Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed Glenoid, Tornier, Inc. (2016) Summary page 5.

## Most influential descendants
- K233712: PRIMA Humeral System; PRIMA TT Glenoid (2024), 1 descendant of its own
- K251184: AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA Humeral System; PRIMA Glenoid System (2025), 0 descendants of its own

## Recalls of this device
- Aug 29, 2023 · Class II · Z-0726-2024: Potential for baseplate peripheral holes to be out of specification due to a manufacturing issue, which could lead to loosening of the implant, or the screw moving from its original position.
- May 30, 2023 · Class II · Z-2009-2023: Due to manufacturing issue, their is a potential for peripheral holes to be out of specification.
- May 30, 2023 · Class II · Z-2010-2023: Due to manufacturing issue, their is a potential for peripheral holes to be out of specification.

## Indications for use
The PRIMA Glenoid 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 PRIMA Glenoid System components are intended for uncemented use with the addition of screw fixation.

Source page: https://510kreport.com/device/K222427
Methodology: https://510kreport.com/methodology