Link Embrace Shoulder System
The bone screws in the Link Embrace reverse shoulder system secure the glenoid baseplate. The baseplate accommodates a central bone screw and up to four peripheral screws. Available…
The bone screws in the Link Embrace reverse shoulder system secure the glenoid baseplate. The baseplate accommodates a central bone screw and up to four peripheral screws. Available fixation designs include locking, polyaxial locking and standard screws with cortical or cancellous threads.
The cementless baseplate carries a glenosphere connected by a taper and locking screw. It forms the glenoid side of the reverse shoulder construct. The bone screws provide baseplate fixation, distinct from the locking screw at the glenosphere connection.
Listed Item
Bone Screws, and Central Cancellous Bone Screw, Co
Reverse Shoulder Applications
The system is intended for primary, fracture or revision total shoulder replacement in a grossly rotator-cuff-deficient joint with severe arthropathy. A functioning deltoid and suitable joint anatomy are required. These conditions apply to the shoulder reconstruction containing the screws.
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 | Waldemar Link GmbH & Co. KG, Germany |
|---|---|
| FDA product code | PHX |
| Device type | Shoulder Prosthesis, Reverse Configuration |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3660 |
| Establishment | Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K200368 |
| Record published | 2021-03-24 |
| Record revised | 2025-02-06 (version 4) |
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, serial number |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 643-242/20 | In distribution | |
| 643-242/23 | In distribution | |
| 645-073/60 | In distribution | |
| 643-036/10 | In distribution | |
| 645-073/30 | In distribution | |
| 641-120/15 | In distribution | |
| 641-120/16 | In distribution | |
| 643-239/03 | In distribution | |
| 645-073/35 | In distribution | |
| 643-239/10 | In distribution | |
| 643-042/26 | In distribution | |
| 643-242/13 | In distribution | |
| 645-070/35 | In distribution | |
| 643-239/06 | In distribution | |
| 643-036/16 | In distribution | |
| 641-120/13 | In distribution | |
| 645-080/20 | In distribution | |
| 641-120/18 | In distribution | |
| 641-120/23 | In distribution | |
| 643-042/06 | In distribution | |
| 645-070/50 | In distribution | |
| 640-100/19 | In distribution | |
| 643-239/26 | In distribution | |
| 640-100/18 | In distribution | |
| 643-036/03 | In distribution | |
| 643-036/06 | In distribution | |
| 643-036/20 | In distribution | |
| 641-120/17 | In distribution | |
| 645-073/25 | In distribution | |
| 643-239/20 | In distribution | |
| 646-042/03 | In distribution | |
| 641-120/20 | In distribution | |
| 645-077/30 | In distribution | |
| 645-077/20 | In distribution | |
| 640-110/23 | In distribution | |
| 643-042/13 | In distribution | |
| 643-039/23 | In distribution | |
| 640-100/23 | In distribution | |
| 640-110/16 | In distribution | |
| 643-236/03 | 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 |
|---|---|
| K231445 | 2023-11-16 |
| K212992 | 2021-11-18 |
| K200368 | 2021-02-05 |
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.