Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System - Stem (Tornier PHS-Stem)

Q: What is the product code of K241878?

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.

FDA 510(k) K241878 · Stryker Corporation (Tornier, Inc.)

Substantially Equivalent

510(k) numberK241878

Submission

Device name: Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System - Stem (Tornier PHS-Stem)
Applicant: Stryker Corporation (Tornier, Inc.)
Bloomington, MN, US
Received: June 28, 2024
Decision date: December 6, 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)	Device	Applicant	Decision
K260721	Tornier Perform Advanced GlenoidKWS · Traditional	Tornier, Inc.	07/22/2026SE
K254084	AETOS Shoulder System - CONCELOC GlenoidsKWS · Traditional	Smith & Nephew, Inc.	04/06/2026SE
K252418	Catalyst F1x Shoulder SystemKWS · Traditional	Catalyst Orthoscience, Inc.	11/06/2025SE
K252416	AETOS Shoulder System Meta Humeral Prosthesis Size 0KWS · Traditional	Smith & Nephew, Inc.	10/29/2025SE
K241292	MyShoulder Planner (5.3SSWPL)KWS · Traditional	Medacta International S.A.	01/30/2025SE
K241609	Tornier Humeral Reconstruction System (Tornier HRS)KWS · Traditional	Stryker Corporation (Tornier, Inc.)	09/10/2024SE
K230513	Arthrex Univers Apex OptiFit Humeral StemKWS · Traditional	Arthrex, Inc.	09/26/2023SE
K222592	AltiVate® Anatomic Shoulder AG e+ with MarkersKWS · Abbreviated	Encore Medical L.P.	06/23/2023SE
K230572	AETOS Shoulder SystemKWS · Traditional	Smith & Nephew, Inc.	06/07/2023SE
K220847	AETOS Shoulder SystemKWS · Traditional	Smith & Nephew, Inc.	01/03/2023SE

More from Smith & Nephew, Inc.

510(k)	Device	Decision
K260102	Tornier Perform Reversed Glenoid and Tornier Perform Reversed Augmented Glenoid Shoulder…PHX · Traditional	06/12/2026SE
K241609	Tornier Humeral Reconstruction System (Tornier HRS)KWS · Traditional	09/10/2024SE

Questions and answers

When was Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System - Stem (Tornier PHS-Stem) cleared by the FDA?

Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System - Stem (Tornier PHS-Stem) (K241878) received a 510(k) decision of Substantially Equivalent on December 6, 2024, 161 days after the submission was received.

What is the product code of K241878?

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.