A sterile implantable device designed to treat a disease-damaged (e.g., arthritic) shoulder joint by replacing the humeral articulating surface of the joint while preserving the natural humerus. It consists of a metallic humeral cap [e.g., titanium (Ti), cobal
| Company | Devices | Share |
|---|---|---|
| Catalyst Orthoscience Inc. | 18 | 20% |
| Ascension Orthopedics, Inc. | 16 | 18% |
| Tornier | 12 | 13% |
| Smith & Nephew, Inc. | 12 | 13% |
| Limacorporate Spa | 12 | 13% |
| Biomet Orthopedics, Llc | 8 | 9% |
| Exactech, Inc. | 6 | 7% |
| Biocore9, Llc | 4 | 4% |
| Endotec, Inc. | 3 | 3% |
Company = labeler of record on GUDID. 9 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 |
|---|---|---|
| HSD | PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED | 46 |
| HSD | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | 45 |
| KWS | PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENT | 30 |
| KWS | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cement | 12 |
| KWT | Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemente | 9 |
| MBF | PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEM | 6 |
Use these as the dimensions to specify in a tender line.
91 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Resurfacing humeral head prosthesis", from 9 companies. The largest labeler is Catalyst Orthoscience Inc. with 20% of records.
HSD (PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED), HSD (Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented), KWS (PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENT), KWS (Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cement)
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.