Tornier Humeral Reconstruction System (Tornier HRS)

FDA 510(k) K241609 · Stryker Corporation (Tornier, Inc.)

Substantially Equivalent

510(k) numberK241609

Submission

Device name
Tornier Humeral Reconstruction System (Tornier HRS)
Applicant
Stryker Corporation (Tornier, Inc.)
Bloomington, MN, US
Received
June 5, 2024
Decision date
September 10, 2024
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
KWS – Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3660
Specialty
Orthopedic
Implant
Yes

Other 510(k)s with product code KWS

510(k)DeviceApplicantDecision
K260721Tornier Perform Advanced GlenoidKWS · Traditional Tornier, Inc.07/22/2026SE
K254084AETOS Shoulder System - CONCELOC GlenoidsKWS · Traditional Smith & Nephew, Inc.04/06/2026SE
K252418Catalyst F1x Shoulder SystemKWS · Traditional Catalyst Orthoscience, Inc.11/06/2025SE
K252416AETOS Shoulder System Meta Humeral Prosthesis Size 0KWS · Traditional Smith & Nephew, Inc.10/29/2025SE
K241292MyShoulder Planner (5.3SSWPL)KWS · Traditional Medacta International S.A.01/30/2025SE
K241878Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System -…KWS · Traditional Stryker Corporation (Tornier, Inc.)12/06/2024SE
K230513Arthrex Univers Apex OptiFit Humeral StemKWS · Traditional Arthrex, Inc.09/26/2023SE
K222592AltiVate® Anatomic Shoulder AG e+™ with MarkersKWS · Abbreviated Encore Medical L.P.06/23/2023SE
K230572AETOS Shoulder SystemKWS · Traditional Smith & Nephew, Inc.06/07/2023SE
K220847AETOS Shoulder SystemKWS · Traditional Smith & Nephew, Inc.01/03/2023SE

More from Smith & Nephew, Inc.

510(k)DeviceDecision
K260102Tornier Perform Reversed Glenoid and Tornier Perform Reversed Augmented Glenoid Shoulder…PHX · Traditional 06/12/2026SE
K241878Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System -…KWS · Traditional 12/06/2024SE

Questions and answers

When was Tornier Humeral Reconstruction System (Tornier HRS) cleared by the FDA?

Tornier Humeral Reconstruction System (Tornier HRS) (K241609) received a 510(k) decision of Substantially Equivalent on September 10, 2024, 97 days after the submission was received.

What is the product code of K241609?

The FDA product code is KWS – Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented, a Class II (moderate risk) device regulated under 21 CFR 888.3660.