Who else makes this device?

Name: Tornier HRS Max
Brand: Tornier HRS Max

Orthopedic › ProstheticProsthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented

Tornier HRS Max

2 catalogue numbers from ARS1040720, listed by Tornier Inc., United States, under Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented. 6 manufacturers in China are registered for this product code.

Registry build 21.09.26

6manufacturers in China registered for this device type

2catalogue numbers in this listing

1510(k) clearance

Who Else Makes It

Concentrated in Jiangsu (3), Shanghai (2), Zhejiang (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code KWT
Manufacturer	City	Province	Registered as	Device types
Paragon Medical Device (Changzhou) Co., Ltd.	Changzhou	Jiangsu	Contract manufacturer	53
Zimmer (Shanghai) Medical International Trading Co., Ltd.	Shanghai	Shanghai	Exporter	106
Zhejiang Biomet Medical Products Co., Ltd.	Jinhua	Zhejiang	Contract manufacturer	74
Shanghai JPY ION-Tech Co., Ltd.	Shanghai	Shanghai	Contract manufacturer	70
Changzhou Biomet Medical Devices Co., Ltd.	Changzhou	Jiangsu	Contract manufacturer	54
Johnson & Johnson Medical (Depuy – Suzhou) Ltd.	Suzhou	Jiangsu	Manufacturer	34

Record

Regulatory record for Tornier HRS Max
Listed by	Tornier Inc., United States
FDA product code	KWT
Device type	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
Device class	Class 2
Regulation	21 CFR 888.3650
Establishment	Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer, Exporter
510(k)	K251686
Record published	2025-11-19

Specifications

Specifications
MRI safety	MR Conditional
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Label carries	expiry date, manufacturing date, serial number
Sizes	Length 20 mm; outer diameter 10 mm

Catalogue Numbers

Catalogue numbers for Tornier HRS Max
Catalogue number	Size	Status
ARS1040720	Size: 20	In distribution
ARS1040610	Size: 10	In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Equinoxe	Exactech, Inc.	336
SMR Shoulder	Limacorporate	289
Tornier Perform Humeral System	Tornier Inc.	119
Bigliani/Flatow®	Zimmer, Inc.	119
Trabecular Metal®	Zimmer, Inc.	115
Jarvis Glenoid Rerverse Shoulder Prosthesis	Fournitures Hospitalieres Industrie	103
Comprehensive® Shoulder System	Biomet Orthopedics	86
Alliance®	Zimmer, Inc.	68
Anatomical Shoulder™	Zimmer, Inc.	54
Aetos Shoulder System	Smith & Nephew, Inc.	53
Perform™ Humeral System	Tornier Inc.	47
Bio-Modular® Shoulder System	Biomet Orthopedics	43

Showing 12 of 164. All products under Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K251686	2025-10-30

Recalls Naming This Product

1 recall names this product by its own identifier, the 510(k) it is cleared under.

Recalls naming the identifiers of Tornier HRS Max
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity
Tornier Inc.	510(k) number	2026-03-05	Class II	Labeling design	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.	233

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.