Aequalis™ Flex Revive™
Screwless Trial Proximal Body
8manufacturers in China registered for this device type
39catalogue 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 | 2020-07-13 |
| Record revised | 2026-03-04 (version 5) |
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 ° |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ARS980910 | Length 130 mm | In distribution |
| ARS655103 | In distribution | |
| ARS741709 | Size SHORT | In distribution |
| ARS916901 | Length 40 mm | In distribution |
| ARS741801 | Outer Diameter 9 mm | In distribution |
| ARS342009 | Outer Diameter 13 mm | In distribution |
| ARS741702 | Angle 132.5 ° | In distribution |
| ARS741710 | Size SHORT | In distribution |
| ARS342002 | Outer Diameter 11 mm | In distribution |
| ARS744105 | Outer Diameter 17 mm | In distribution |
| ARS980908 | Length 130 mm | In distribution |
| ARS980913 | Outer Diameter 9 mm | In distribution |
| ARS741821 | Length 210 mm | In distribution |
| ARS741711 | Size SHORT | In distribution |
| ARS741701 | Angle 132.5 ° | In distribution |
| ARS980920 | Length 210 mm | In distribution |
| ARS655119 | Size SHORT | In distribution |
| ARS741820 | Length 210 mm | In distribution |
| ARS980921 | Outer Diameter 13 mm | In distribution |
| ARS980923 | Length 210 mm | In distribution |
| ARS741807 | Outer Diameter 9 mm | In distribution |
| ARS744106 | Outer Diameter 19 mm | In distribution |
| ARS742201 | Outer Diameter 9 mm | In distribution |
| ARS744102 | Outer Diameter 11 mm | In distribution |
| ARS741814 | Outer Diameter 11 mm | In distribution |
| ARS342003 | Outer Diameter 13 mm | In distribution |
| ARS741803 | Outer Diameter 13 mm | In distribution |
| ARS980905 | Outer Diameter 17 mm | In distribution |
| ARS342011 | Outer Diameter 17 mm | In distribution |
| ARS916904 | Outer Diameter 13 mm | In distribution |
| ARS742301 | Outer Diameter 9 mm | In distribution |
| ARS980901 | Outer Diameter 9 mm | In distribution |
| ARS742401 | Outer Diameter 9 mm | In distribution |
| ARS744300 | In distribution | |
| ARS742303 | Outer Diameter 13 mm | In distribution |
| ARS742202 | Outer Diameter 11 mm | In distribution |
| ARS742505 | Outer Diameter 17 mm | In distribution |
| ARS741818 | Length 170 mm | In distribution |
| ARS742302 | 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 |
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.