An implantable, hemisphere-shaped component of a bipolar partial shoulder prosthesis designed to interface with the glenoid fossa on its outer surface where it freely rotates, and interface with a humeral head prosthesis on its inner surface where it allows fr
| Company | Devices | Share |
|---|---|---|
| Endotec, Inc. | 69 | 78% |
| Synovo Production | 20 | 22% |
Company = labeler of record on GUDID. 2 companies in total; top 12 shown. Click headers to sort.
Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.
| Code | Name | Devices |
|---|---|---|
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | 96 |
| KWL | Prosthesis, Hip, Hemi-, Femoral, Metal | 68 |
| LZY | Prosthesis, Hip, Hemi-, Femoral, Metal Ball | 20 |
| KWT | Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemente | 4 |
| HSD | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | 4 |
| MJT | Prosthesis, Shoulder, Humeral (Bipolar Hemi-Shoulder) Metal/ | 4 |
Use these as the dimensions to specify in a tender line.
89 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Bipolar humeral head outer component", from 2 companies. The largest labeler is Endotec, Inc. with 78% of records.
JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented), KWL (Prosthesis, Hip, Hemi-, Femoral, Metal), LZY (Prosthesis, Hip, Hemi-, Femoral, Metal Ball), KWT (Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemente)
No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.
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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.