# K160975: Aequalis PerFORM+ Shoulder System

- Pathway: 510(k) (Special)
- Applicant: Tornier, Inc.
- Decided: Jun 10, 2016 after 64 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: 11 generations back to K920362 (1993). 71 ancestors in all.
7 later devices descend from it; 2 cite it directly.
0 of 79 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150583: Aequalis PerFORM+ Shoulder System, Tornier, Inc. (2015) Summary page 4.

## Most influential descendants
- K220847: AETOS Shoulder System (2023), 5 descendants of its own
- K240716: AETOS Shoulder System Stemless Humeral Prosthesis (2024), 3 descendants of its own
- K230572: AETOS Shoulder System (2023), 1 descendant of its own
- K260721: Tornier Perform Advanced Glenoid (2026), 0 descendants of its own
- K254084: AETOS Shoulder System - CONCELOC Glenoids (2026), 0 descendants of its own

## Indications for use
Prosthetic replacement with this device (Aequalis PerFORM+ glenoid component and humeral component) may be indicated to relieve severe pain or significant disability caused by: • Degenerative pathologies: arthrosis, rheumatoid arthrosis, post traumatic arthrosis • Primary and secondary necrosis of the humeral head • Displaced 4-part upper humeral fracture • 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 PerFORM+ glenoids are intended for cemented use only. The Aequalis monobloc stem is for cemented use The Aequalis Press-Fit is for uncemented use

Source page: https://510kreport.com/device/K160975
Methodology: https://510kreport.com/methodology