Tornier Humeral Reconstruction System Max (Tornier HRS Max)
FDA 510(k) K251686 · Tornier, Inc.
510(k) numberK251686
Submission
- Device name
- Tornier Humeral Reconstruction System Max (Tornier HRS Max)
- Applicant
- Tornier, Inc.
Bloomington, MN, US - Received
- June 2, 2025
- Decision date
- October 30, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KWT – Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3650
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code KWT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262173 | N22 Offset Humeral HeadKWT · Traditional | Shoulder Innovations, Inc. | 09/08/2026SE |
| K250713 | Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder ImplantsKWT · Traditional | Exactech, Inc. | 12/01/2025SE |
| K241944 | AGILON® XO Shoulder Replacement SystemKWT · Traditional | Implantcast GmbH | 03/10/2025SE |
| K241817 | InSet Total Shoulder SystemKWT · Traditional | Shoulder Innovations, Inc. | 02/11/2025SE |
| K231657 | AGILON® XO Shoulder Replacement SystemKWT · Traditional | Implantcast GmbH | 02/16/2024SE |
| K223631 | Comprehensive Segmental Revision System(SRS)KWT · Traditional | Biomet Orthopedics | 07/12/2023SE |
| K222482 | AGILON XO Shoulder SystemKWT · Traditional | Implantcast GmbH | 09/28/2022SE |
| K210899 | LINK Embrace Shoulder System- Anatomical ConfigurationKWT · Traditional | Waldemar Link GmbH & Co. KG | 06/21/2021SE |
| K191698 | TiN Coated Humeral HeadKWT · Traditional | Fx Shoulder USA, Inc. | 07/16/2020SE |
| K192365 | Shoulder Innovations Total Shoulder SystemKWT · Special | Shoulder Innovations, Inc. | 11/29/2019SE |
More from Shoulder Innovations, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K260721 | Tornier Perform Advanced GlenoidKWS · Traditional | 07/22/2026SE |
| K252788 | Tornier Perform Reversed Monopost Glenoid (Perform Mono)PHX · Traditional | 01/08/2026SE |
| K230352 | Tornier Humeral Nail and Tornier Long Humeral NailHSB · Traditional | 10/31/2023SE |
| K220914 | Tornier Perform Humeral System FracturePHX · Traditional | 10/14/2022SE |
| K220418 | Tornier Perform Humeral System StemlessPKC · Traditional | 09/14/2022SE |
| K211359 | Tornier Perform Patient-Matched Primary Reversed Glenoid and BLUEPRINT Patient…PHX · Traditional | 11/12/2021SE |
| K213124 | Tomier Perform Reversed Glenoid Cannulated GlenospheresPHX · Special | 10/26/2021SE |
| K201315 | PERFORM Humeral System StemPAO · Traditional | 09/11/2020SE |
| K193247 | LATITUDE EV Total Elbow ArthroplastyJDB · Traditional | 08/05/2020SE |
| K191711 | ORTHOLOC SPS Shoulder Plating SystemHRS · Special | 07/17/2019SE |
Questions and answers
When was Tornier Humeral Reconstruction System Max (Tornier HRS Max) cleared by the FDA?
Tornier Humeral Reconstruction System Max (Tornier HRS Max) (K251686) received a 510(k) decision of Substantially Equivalent on October 30, 2025, 150 days after the submission was received.
What is the product code of K251686?
The FDA product code is KWT – Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented, a Class II (moderate risk) device regulated under 21 CFR 888.3650.