# K251686: Tornier Humeral Reconstruction System Max (Tornier HRS Max)

- Pathway: 510(k) (Traditional)
- Applicant: Tornier, Inc.
- Decided: Oct 30, 2025 after 150 days
- Product code: KWT (Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3650
- 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: 19 generations back to K911686 (1991). 171 ancestors in all.
No later device cites it as a predicate yet.
1 of 172 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K223631: Comprehensive Segmental Revision System (SRS), Biomet Orthopedics (2023) Summary page 5.
- K241878: Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System - Stem (Tornier PHS-Stem), Stryker Corporation (Tornier, Inc.) (2024) Summary page 5.

## Recalls of this device
- Mar 5, 2026 · Class II · Z-1769-2026: Affected products were incorrectly labeled as Tornier HRS Max products. These parts are compatible with the Tornier HRS system only, and are incompatible with the Tornier HRS Max system.

## Indications for use
In Anatomic: Tornier HRS Max humeral assembly can be used for anatomic arthroplasty when used with a humeral head. It can be used as a hemiarthroplasty, if the natural glenoid provides a sufficient bearing surface, or in conjunction with a glenoid, as a total replacement. Tornier HRS Max is indicated for use as a replacement of shoulder joints for patients with a functional deltoid muscle and with an intact or reconstructable rotator cuff with pain disabled by: • Rheumatoid arthritis • Non-inflammatory degenerative joint disease (i.e., osteoarthritis and avascular necrosis) • Fractures of the humeral head • Post-Traumatic arthritis • Oncology applications including bone loss due to tumor resection • Significant humeral resection where adequate fixation can be achieved In Reverse: Tornier HRS Max is indicated for use as a replacement of shoulder joints for patients with a functional deltoid muscle and with massive and non-repairable rotator cuff-tear 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 • Post-Traumatic arthritis • Massive and non-repairable rotator cuff tear • Oncology applications including bone loss due to tumor resection. • Significant humeral resection where adequate fixation can be achieved The reversed tray and polyethylene insert are indicated for use in the conversion from an anatomic to reversed shoulder arthroplasty without the removal of a well-fixed humeral assembly during revision surgery for patients with a functional deltoid muscle. Notice: • 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/K251686
Methodology: https://510kreport.com/methodology