Tornier HRS
43 catalogue numbers from ARS741801, listed by Tornier Inc., United States, under Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented. 8 manufacturers in China are registered for this product code.
8manufacturers in China registered for this device type
43catalogue numbers in this listing
3510(k) clearances naming this product code
Who Else Makes It
Concentrated in Shanghai (3), Jiangsu (3), Zhejiang (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| 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 |
| 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 | HSD |
| Device type | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3690 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K181420 |
| Record published | 2023-08-01 |
| Record revised | 2025-02-17 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Sizes | Outer diameter 9 to 19 mm; length 20 to 210 mm; angle 132.5 to 135 ° |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ARS741801 | Outer Diameter 9 mm | In distribution |
| ARS1020605 | Angle 135 ° | In distribution |
| ARS980916 | Outer Diameter 15 mm | In distribution |
| ARS655101 | In distribution | |
| ARS741813 | Length 170 mm | In distribution |
| ARS342002 | Length 20 mm | In distribution |
| ARS980903 | Length 90 mm | In distribution |
| ARS980925 | Length 90 mm | In distribution |
| ARS741712 | Angle 132.5 ° | In distribution |
| ARS741810 | Length 130 mm | In distribution |
| ARS980914 | Outer Diameter 11 mm | In distribution |
| ARS342009 | Outer Diameter 13 mm | In distribution |
| ARS980901 | Outer Diameter 9 mm | In distribution |
| ARS1054401 | Offset: Centered | In distribution |
| ARS1041201 | Size: Medium | In distribution |
| ARS980932 | Length 130 mm | In distribution |
| ARS1020602 | Angle 135 ° | In distribution |
| ARS1020601 | Size: Standard | In distribution |
| ARS742201 | Outer Diameter 9 mm | In distribution |
| ARS980928 | Length 90 mm | In distribution |
| ARS980927 | Outer Diameter 14 mm | In distribution |
| ARS741806 | Length 90 mm | In distribution |
| ARS342010 | Length 30 mm | In distribution |
| ARS1054403 | Offset: High (+3.5) | In distribution |
| ARS742206 | Outer Diameter 19 mm | In distribution |
| ARS741704 | Angle 132.5 ° | In distribution |
| ARS655105 | In distribution | |
| ARS342011 | Length 30 mm | In distribution |
| ARS1020604 | Angle 135 ° | In distribution |
| ARS980923 | Outer Diameter 17 mm | In distribution |
| ARS655102 | In distribution | |
| ARS342001 | Outer Diameter 9 mm | In distribution |
| ARS741817 | Length 170 mm | In distribution |
| ARS980920 | Outer Diameter 11 mm | In distribution |
| ARS980942 | Length 210 mm | In distribution |
| ARS741707 | Outer Diameter 9 mm | In distribution |
| ARS741804 | Outer Diameter 15 mm | In distribution |
| ARS342007 | Outer Diameter 9 mm | In distribution |
| ARS655103 | In distribution | |
| ARS980902 | Outer Diameter 11 mm | In distribution |
| ARS741802 | Outer Diameter 11 mm | In distribution |
| ARS741702 | Angle 132.5 ° | In distribution |
| ARS980904 | Length 90 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Equinoxe | Exactech, Inc. | 345 |
| SMR Shoulder | Limacorporate | 182 |
| FX V135 | Fx Shoulder Solutions SAS | 127 |
| Acumed | Acumed LLC | 112 |
| Promos | Smith & Nephew, Inc. | 104 |
| Trabecular Metal® | Zimmer, Inc. | 90 |
| Bigliani/Flatow® | Zimmer, Inc. | 86 |
| Comprehensive® Shoulder System | Biomet Orthopedics | 85 |
| Arthrex® | Arthrex, Inc. | 75 |
| SMR System | Limacorporate | 72 |
| DJO Surgical | Encore Medical, L.P. | 70 |
| Humeris Shoulder | Fx Solutions | 69 |
Showing 12 of 241. All products under Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K062661 | 2006-12-22 |
| K063081 | 2006-11-09 |
| K011942 | 2001-07-13 |
Recalls Naming This Product
3 recalls name this product by its own identifiers, 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 |
| Tornier Inc. | 510(k) number | 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 |
| Tornier Inc. | 510(k) number | 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 |
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.