# K220914: Tornier Perform Humeral System – Fracture

- Pathway: 510(k) (Traditional)
- Applicant: Tornier, Inc.
- Decided: Oct 14, 2022 after 198 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: 12 generations back to K911686 (1991). 49 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 52 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131231: Aequalis Shoulder Fracture System, Aequalis Reversed Shoulder Prosthesis, Aequalis Reversed Fracture Shoulder Prothesis, Tornier S.A.S. (2013) Summary page 5.

## Most influential descendants
- K240876: Identity Shoulder System (2024), 1 descendant of its own
- K253592: Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Humeral Trays, Comprehensive Reverse 32mm Glenospheres and Adapter) (2026), 0 descendants of its own

## Indications for use
In Anatomic: The Tornier Perform® Humeral System — Fracture combined with a humeral head may be used by themselves, as a hemiarthroplasty, if the natural glenoid provides a sufficient bearing surface, or in conjunction with a glenoid implant, as a total replacement. The Tornier Perform Humeral System — Fracture is to be used only in patients with an intact or reconstructable rotator cuff, where it is intended to provide increased mobility, stability, and to relieve pain. The Tornier Perform Humeral System — Fracture is indicated for use as a replacement of shoulder joints disabled by: * Traumatic or pathologic conditions of the shoulder resulting in fracture of the glenohumeral joint, including humeral head fracture and displaced 3-or 4-part proximal humeral fractures * Fracture sequelae * Revisions where adequate fixation can be achieved and adequate bone stock remains after final reconstruction 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. The fracture stems are intended for cemented or cementless use. In cementless use, the fracture stems are intended for use with or without cortical screws. In a total shoulder arthroplasty, the Tornier Perform Humeral System — Fracture is intended to be used with cemented polyethylene glenoid components. In Reverse: The Tornier Perform Humeral System — Fracture combined with a reverse insert is indicated for use as a replacement of shoulder joints for patients with a functional deltoid muscle, grossly deficient rotator cuff, and pain disabled by: * Traumatic or pathologic conditions of the shoulder resulting in fracture of the glenohumeral joint, including humeral head fracture and displaced 3-or 4-part proximal humeral fractures * Proximal humerus bone defect * Fracture sequelae * Revisions where adequate fixation can be achieved and adequate bone stock remains after final reconstruction The reversed insert is indicated for use for the conversion from an anatomic to reverse shoulder prosthesis without the removal of a well fixed fracture stem for patients with a functional deltoid muscle. All components are single use. The fracture stems are intended for cemented or cementless use. In cementless use, the fracture stems are intended for use with or without cortical screws. The Tornier Perform Humeral System — Fracture is intended to be used with glenoid implants that are anchored to the bone with screws for non-cemented fixation.

Source page: https://510kreport.com/device/K220914
Methodology: https://510kreport.com/methodology