# K241878: Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System - Stem (Tornier PHS-Stem)

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Corporation (Tornier, Inc.)
- Decided: Dec 6, 2024 after 161 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: 18 generations back to K911686 (1991). 142 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 144 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191318: AEQUALIS FLEX REVIVE Shoulder System, Tornier, Inc. (2019) Summary page 7.
- K201315: PERFORM Humeral System – Stem, Tornier, Inc. (2020) Summary page 7.

## Most influential descendants
- K251686: Tornier Humeral Reconstruction System Max (Tornier HRS Max) (2025), 0 descendants of its own

## Indications for use
Tornier Humeral Reconstruction System (Tornier HRS) IN ANATOMIC: The Tornier HRS is to be used only in patients with an intact or reconstructable rotator cuff, where it is intended to provide increased mobility and stability and to relieve pain. The Tornier HRS is indicated for use as a replacement of shoulder joints disabled by: * Rheumatoid arthritis with pain * Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis) * Correction of functional deformity * Fractures of the humeral head * Traumatic arthritis * Revision of other devices if sufficient bone stock remains IN REVERSE: The Tornier HRS is indicated for use as a replacement of shoulder joints for patients with a functional deltoid muscle with pain disabled by: * Rheumatoid arthritis * Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis) * Correction of functional deformity * Fractures of the humeral head » Traumatic arthritis * Massive and non-repairable rotator cuff tear * Revision of other devices if sufficient bone stock remains The reversed tray and polyethylene insert are indicated for use in the conversion from an anatomic to reversed shoulder arthroplasty without the removal of the humeral assembly during revision surgery for patients with a functional deltoid muscle. Notes: * All components are single use. » The coated humeral stem is intended for cemented or cementless use. * The all-poly glenoid components are intended for cemented use only » The glenoid sphere implant is anchored to the bone with screws and is for non-cemented fixation. « 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 who lack a suspected material sensitivity to cobalt alloy. Tornier Perform Humeral System - Stem (Tornier PHS-Stem) In Anatomic: The humeral stem, humeral head coupler and 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 PERFORM™ Humeral System — Stem 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 PERFORM Humeral System — Stem is indicated for use as a replacement of shoulder joints disabled by: * Non-inflammatory degenerative joint disease (i.e. osteoarthritis) and avascular necrosis * Proximal humeral malunions * Post-traumatic arthritis * Revisions or fractures of the humeral head where adequate fixation can be achieved and adequate bone stock remains 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 recommended for patients with a suspected material sensitivity to cobalt alloy. All components are single use. The humeral stems are intended for cemented or cementless use. The PERFORM Humeral System — Stem is intended to be used with cemented polyethylene glenoid components, in a total shoulder arthroplasty. In Reverse: The PERFORM™ Humeral System — Stem is indicated for use as a replacement of a shoulder joint for patients with a functional deltoid muscle, grossly deficient rotator cuff, and pain disabled by one or more of the following: * Non-inflammatory degenerative joint disease (i.e. osteoarthritis) and avascular necrosis * Pseudoparalysis or anterior superior escape * Rotator cuff tear arthropathy * Proximal humeral malunions * Post-traumatic arthritis * Revisions or fractures of the humeral head where adequate fixation can be achieved and adequate bone stock remains The reversed insert is indicated for use for the conversion from an anatomic to reverse shoulder prosthesis without the removal of a well fixed humeral stem for patients with a functional deltoid muscle. All components are single use. The humeral stems are intended for cemented or cementless use. The PERFORM Humeral System — Stem 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/K241878
Methodology: https://510kreport.com/methodology