Tornier Humeral Reconstruction System Max (Tornier HRS Max)— 510(k) K251686

Clearance details

Applicant

Tornier, Inc.

Product code

Code KWT

Device class

Class 2

Regulation

21 CFR 888.3650

Advisory panel

Orthopedic

Date received

2025-06-02

Decision date

2025-10-30

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Bloomington, MN, US

• K262173 — N22 Offset Humeral Head2026-09-08
• K250713 — Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder Implants2025-12-01
• K241944 — AGILON® XO Shoulder Replacement System2025-03-10
• K241817 — InSet Total Shoulder System2025-02-11
• K231657 — AGILON® XO Shoulder Replacement System2024-02-16

• K260721 — Tornier Perform Advanced Glenoid2026-07-22
• K252788 — Tornier Perform Reversed Monopost Glenoid (Perform Mono)2026-01-08
• K230352 — Tornier Humeral Nail and Tornier Long Humeral Nail2023-10-31
• K220914 — Tornier Perform Humeral System Fracture2022-10-14
• K220418 — Tornier Perform Humeral System Stemless2022-09-14

Injury

2,467

Other

2

Total

2,469

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-1769-2026 — Tornier HRS Max parts: 1. TORNIER HRS Max Tuberosity Body Lat Coat, Small, Cat. No. ARS1041101 2. TORNIER HRS Max Tuberosity Body No Coat, Small, Cat. No. ARS1041102 3. TORNIER HRS Max Trial, Cat. No. ARS10252Class II·Ongoing·Tornier, Inc·20260305

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K251686.