# K150583: Aequalis PerFORM+ Shoulder System

- Pathway: 510(k) (Special)
- Applicant: Tornier, Inc.
- Decided: Apr 23, 2015 after 45 days
- Product code: KWS (Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented)
- 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: 10 generations back to K920362 (1993). 70 ancestors in all.
16 later devices descend from it; 3 cite it directly.
0 of 87 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111902: Aequalis Shoulder System, Tornier (2011) Summary page 4.
- K092122: Global Shoulder Steptech Anchor Peg Glenoid, DePuy Orthopaedics, Inc. (2009) Summary page 4.
- K121220: Equinoxe Glenoid, Uhmwpe 16 PS=Osterior Augment Pegged, Small, Left/Right, Exactech, Inc. (2012) Summary page 4.

## Most influential descendants
- K160975: Aequalis PerFORM+ Shoulder System (2016), 7 descendants of its own
- K152825: Catalyst CSR Shoulder System (2016), 7 descendants of its own
- K220847: AETOS Shoulder System (2023), 5 descendants of its own
- K240716: AETOS Shoulder System Stemless Humeral Prosthesis (2024), 3 descendants of its own
- K181287: Catalyst CSR Shoulder System (2018), 3 descendants of its own

## Indications for use
Prosthetic replacement with this device may be indicated to relieve severe pain or significant disability caused by: o Degenerative pathologies: arthrosis, rheumatoid arthritis, post-traumatic arthrosis. Primary or secondary necrosis of the humeral head. o Displaced 4-part upper humeral fracture o Humeral head fracture Other pathologies where arthrodesis or resectional arthroplasty of the humeral head are not acceptable. Revision surgery when other treatments or devices have failed. The Aequalis monobloc stem is cemented use. The Aequalis press-fit is for uncemented use. Glenoid component is for cemented use.

Source page: https://510kreport.com/device/K150583
Methodology: https://510kreport.com/methodology