MSS – Humeral Reverse Liners Extension
MSS Humeral Reverse Liners are bearing components for the reverse configuration of the Medacta Shoulder System. They replace the humeral side of the shoulder articulation within the…
MSS Humeral Reverse Liners are bearing components for the reverse configuration of the Medacta Shoulder System. They replace the humeral side of the shoulder articulation within the compatible implant construct.
The constrained liners are made from E-Cross ultra-high molecular weight polyethylene with vitamin E. Small and large metaphyseal coupling interfaces allow pairing with the corresponding humeral components.
Listed Item
Hum. rev. constrained E-CROSS liner Ø39/+0 – SMALL
Liner Configuration
The constrained design modifies the liner’s containment geometry, including its jump height, while retaining the compatible system interface and selected articular dimensions. Liners are supplied individually packaged, ethylene oxide sterilized and intended for single use. They are intended for reverse shoulder replacement rather than an anatomic configuration.
Who Else Makes It
Concentrated in Jiangsu (5), Shanghai (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 |
|---|---|---|---|---|
| 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 |
| Changzhou Atomic HI-Tech Radiation Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 8 |
Record
| Listed by | Medacta International SA, Switzerland |
|---|---|
| FDA product code | PHX |
| Device type | Shoulder Prosthesis, Reverse Configuration |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3660 |
| Establishment | Specification developer, Repacker / relabeller, Private-label distributor, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K261016 |
| Record published | 2026-06-16 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 04.01.0526 | In distribution | |
| 04.01.0528 | In distribution | |
| 04.01.0523 | In distribution | |
| 04.01.0535 | In distribution | |
| 04.01.0529 | In distribution | |
| 04.01.0527 | In distribution | |
| 04.01.0521 | In distribution | |
| 04.01.0531 | In distribution | |
| 04.01.0532 | In distribution | |
| 04.01.0539 | In distribution | |
| 04.01.0534 | In distribution | |
| 04.01.0540 | In distribution | |
| 04.01.0530 | In distribution | |
| 04.01.0536 | In distribution | |
| 04.01.0537 | In distribution | |
| 04.01.0538 | In distribution | |
| 04.01.0524 | In distribution | |
| 04.01.0525 | In distribution | |
| 04.01.0520 | In distribution | |
| 04.01.0522 | In distribution | |
| 04.01.0533 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Arthrex® | Arthrex, Inc. | 297 |
| FX V135 | Fx Shoulder Solutions SAS | 131 |
| Prima TT Glenoid | Limacorporate | 129 |
| Shoulder Innovations Inset Reverse Total Shoulder | Shoulder Innovations, Inc | 124 |
| Equinoxe | Exactech, Inc. | 123 |
| Veritas rTSA | restor3d, inc. | 112 |
| DJO Surgical | Encore Medical, L.P. | 109 |
| R1 Reverse Shoulder System | Catalyst Orthoscience Inc | 100 |
| Tornier Perform™ Humeral System | Tornier Inc. | 96 |
| MSS – Monobloc stem | Medacta International SA | 92 |
| SMR Shoulder | Limacorporate | 90 |
| Humelock II Cemented Reversible Shoulder | Fx Solutions | 83 |
Showing 12 of 232. All products under Shoulder Prosthesis, Reverse Configuration
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K261016 | 2026-06-10 |
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.