# K241609: Tornier Humeral Reconstruction System (Tornier HRS)

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Corporation (Tornier, Inc.)
- Decided: Sep 10, 2024 after 97 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: 17 generations back to K911686 (1991). 103 ancestors in all.
No later device cites it as a predicate yet.
1 of 104 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 6.
- K181420: Aequalis Flex Revive Shoulder System, Tornier, Inc. (2018) Summary page 6.

## Indications for use
IN ANATOMIC: The proximal body, stem, assembly screw, locking cap, optional spacer(s), and humeral head may be used together, as a hemiarthroplasty, if the natural glenoid provides a sufficient bearing surface, or in conjunction with the glenoid, as a total replacement. The Tornier HRS Shoulder System 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 Shoulder System 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 Shoulder System 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 the 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.

Source page: https://510kreport.com/device/K241609
Methodology: https://510kreport.com/methodology