Tornier HRS Max
Deltoid Wrapping Proximal Body
9manufacturers in China registered for this device type
12catalogue numbers in this listing
24510(k) clearances naming this product code
6recalls on this code
Who Else Makes It
Concentrated in Jiangsu (5), Shanghai (3), Zhejiang (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Stryker Orthmed (Changzhou) Medical Instrument Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 10 |
| Stryker Trauson (Changzhou) Medical Technology Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 3 |
| 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 |
| Arthrex (Shanghai) Co., Ltd. | Shanghai | Shanghai | Exporter | 38 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
Record
| Listed by | Tornier Inc., United States |
|---|---|
| FDA product code | KWS |
| Device type | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3660 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K251686 |
| Record published | 2025-11-19 |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Sizes | Outer diameter 9 to 18 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ARS1040616 | Size: 16 | In distribution |
| ARS1024313 | Size: 13 | In distribution |
| ARS1024314 | Size: 14 | In distribution |
| ARS1024311 | Size: 11 | In distribution |
| ARS1040609 | Outer Diameter 9 mm | In distribution |
| ARS10409 | Size: Medium | In distribution |
| ARS1040611 | Size: 11 | In distribution |
| ARS1024310 | Outer Diameter 10 mm | In distribution |
| ARS1024318 | Size: 18 | In distribution |
| ARS1040618 | Outer Diameter 18 mm | In distribution |
| ARS1040617 | Outer Diameter 17 mm | In distribution |
| ARS1024315 | Size: 15 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Equinoxe | Exactech, Inc. | 442 |
| Reunion | Stryker GmbH | 321 |
| DJO Surgical | Encore Medical, L.P. | 266 |
| SMR Shoulder | Limacorporate | 209 |
| Tornier Flex Shoulder System | Tornier Inc. | 187 |
| Anatomical Shoulder™ | Zimmer, Inc. | 166 |
| Arthrex® | Arthrex, Inc. | 154 |
| Comprehensive Shoulder System | Biomet Orthopedics | 111 |
| Flex Shoulder System | Tornier Inc. | 109 |
| Aequalis™ PerFORM+ | Tornier Inc. | 108 |
| Aequalis™ Ascend™ Flex | Tornier Inc. | 102 |
| Anatomic Shoulder Prosthesis | Medacta International SA | 90 |
Showing 12 of 326. All products under Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K260721 | 2026-07-22 |
| K191318 | 2019-06-14 |
| K181420 | 2018-09-20 |
| K160975 | 2016-06-10 |
| K150583 | 2015-04-23 |
| K121493 | 2012-06-20 |
| K120794 | 2012-04-13 |
| K113413 | 2012-03-09 |
| K111902 | 2011-11-03 |
| K110865 | 2011-04-27 |
| K102924 | 2011-01-31 |
| K103007 | 2010-11-09 |
| K082120 | 2008-10-24 |
| K081707 | 2008-07-17 |
| K060209 | 2006-03-02 |
| K043077 | 2004-12-17 |
| K041339 | 2004-06-17 |
| K032679 | 2003-12-15 |
| K012212 | 2001-08-15 |
| K003728 | 2000-12-20 |
| K994393 | 2000-06-22 |
| K994392 | 2000-03-10 |
| K980244 | 1999-08-23 |
| K952928 | 1995-09-27 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| 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 |
Recalls
5 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2025-12-19 | Class II | Labeling mix-ups | A specific lot of screws is incorrectly labeled. Screws are labeled as 5.0mmx18mm but actual screws are 5.00mmx14mm. If mismatch is detected during surgery, the issue may cause a minor delay in surgery. If not detected and incorrect screw i | 427 | |
| 2023-06-12 | Class II | Under Investigation by firm | A comingle/swap resulted in the labeling and laser marking on the product to state it is a Aequalis Flex Revive Assembly Screw 0mm Standard (ARS655101) but it was a Aequalis Flex Revive Assembly Screw 0mm Short (ARS655118) & vice versa. | 55 units | |
| 2023-06-12 | Class II | Under Investigation by firm | A comingle/swap resulted in the labeling and laser marking on the product to state it is a Aequalis Flex Revive Assembly Screw 0mm Standard (ARS655101) but it was a Aequalis Flex Revive Assembly Screw 0mm Short (ARS655118) & vice versa. | 55 units | |
| 2021-05-28 | Class II | Employee error | Two lots have been swapped thus have the incorrect product in the package. The component may be of a different thickness. | 20 | 2023-04-14 |
| 2016-09-19 | Class II | Component design/selection | Tornier is conducting a recall on Aequalis Fx2 ( implant parts and instrument trays) due to reports of dislocations of the poly insert and the stem. | 30 | 2018-05-31 |
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.