CeMend Shoulder Spacer
The CeMend Shoulder Spacer is a temporary shoulder spacer made with PMMA bone cement with Gentamicin and reinforced with a stainless steel core. The subject device is provided sterile,…
The CeMend Shoulder Spacer is a temporary shoulder spacer made with PMMA bone cement with Gentamicin and reinforced with a stainless steel core. The subject device is provided sterile, single use and is intended for temporary (maximum 180 days) use as part of a two-stage procedure in skeletally mature patients undergoing total or hemi shoulder arthroplasty revision due to prosthetic joint infection.
Who Else Makes It
Registered in Shanghai.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
Record
| Listed by | G21 SRL |
|---|---|
| FDA product code | MBB |
| Device type | Bone Cement, Antibiotic |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3027 |
| 510(k) | K252443 |
| Record published | 2025-12-19 |
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 |
|---|---|---|
| AR-902-1042 | In distribution | |
| AR-902-0842 | In distribution | |
| AR-902-1248 | In distribution | |
| AR-902-1048 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Remedy Spacer | Osteoremedies, LLC | 28 |
| CeMend Shoulder Spacer Mold | G21 SRL | 12 |
| Palacos® | Heraeus Medical LLC | 8 |
| StageOne™ | Biomet Orthopedics | 8 |
| SpaceFlex Shoulder | G21 SRL | 6 |
| Interspace Tapered Wedge Stem | Tecres SPA | 6 |
| InterSpace Hip | Tecres SPA | 6 |
| Surespace | Ortho Development Corp. | 5 |
| Prostalac | Depuy Orthopaedics, Inc. | 4 |
| Rally | Smith & Nephew, Inc. | 3 |
| Smartset | Depuy (Ireland) | 3 |
| SpaceFlex Knee | G21 SRL | 3 |
Showing 12 of 44. All products under Bone Cement, Antibiotic
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.