# K220418: Tornier Perform Humeral System – Stemless

- Pathway: 510(k) (Traditional)
- Applicant: Tornier, Inc.
- Decided: Sep 14, 2022 after 212 days
- Product code: PKC (Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained)
- Device class: 2
- Regulation: 21 CFR 888.3660
- Recalls of this device: 1 (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). 142 ancestors in all.
No later device cites it as a predicate yet.
1 of 143 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143552: Simpliciti Shoulder System, Tornier, Inc. (2015) Summary page 4.
- K201315: PERFORM Humeral System – Stem, Tornier, Inc. (2020) Summary page 4.

## Recalls of this device
- Aug 29, 2024 · Class II · Z-3155-2024: One lot of Perform Humeral Nucleus may exceed the specification for bacterial endotoxin load (max 20 EU/device).

## Indications for use
The nucleus, humeral head coupler and humeral head are used in conjunction with a glenoid implant as a total replacement. The Tornier Perform® Humeral System – Stemless is to be used only in patients with an intact or reconstructable rotator cuff, where it is intended to provide mobility, stability, and to relieve pain. The Tornier Perform Humeral System – Stemless is indicated for use as a replacement of shoulder joints disabled by: • Non-inflammatory degenerative joint disease (i.e. osteoarthritis) and avascular necrosis • Post-traumatic arthritis Titanium humeral heads are intended for patients with suspected cobalt alloy material sensitivity. The wear properties of titanium and titanium alloys are inferior to that of cobalt alloy. A titanium humeral head is not recommended for patients without a suspected material sensitivity to cobalt alloy. All components are single use and intended for cementless use. The Tornier Perform Humeral System – Stemless is intended to be used with cemented polyethylene glenoid components, in an anatomic total shoulder arthroplasty.

Source page: https://510kreport.com/device/K220418
Methodology: https://510kreport.com/methodology