Palacos®
PALACOS® R+G is a fast setting polymer containing gentamicin, for use in bone surgery. Mixing of the two component system, consisting of a powder and a liquid, initially produces a liquid…
PALACOS® R+G is a fast setting polymer containing gentamicin, for use in bone surgery. Mixing of the two component system, consisting of a powder and a liquid, initially produces a liquid and then a paste, which is used to anchor the prosthesis to the bone. The hardened bone cement allows stable fixation of the prosthesis and Transfers all stresses produced in a movement to the bone via the large interface. Insoluble zirconium dioxide is included in the cement powder as an X ray contrast medium. The chlorophyll additive serves as optical marking of the bone cement at the site of the operation.
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 | Heraeus Medical LLC, United States |
|---|---|
| FDA product code | MBB |
| Device type | Bone Cement, Antibiotic |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3027 |
| Establishment | Complaint-file establishment, Manufacturer |
| 510(k) | K210607 |
| Record published | 2021-07-15 |
| Record revised | 2023-10-25 (version 9) |
Specifications
| MRI safety | MR Safe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature 4 to 25 °C |
| Packaging | Paper carton of 6, pallet of 144, pallet of 400, paper carton of 20, shipping box of 20, palett of 144 |
| Distribution end date | 2017-08-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| R+G pro 80 | In distribution | |
| MV+G pro 40 | In distribution | |
| MV+G pro 80 | In distribution | |
| R+G | In distribution | |
| R+G pro 40 | In distribution | |
| LV+G | In distribution | |
| R+G | Withdrawn | |
| LV+G | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Remedy Spacer | Osteoremedies, LLC | 28 |
| CeMend Shoulder Spacer Mold | G21 SRL | 12 |
| 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 |
| CeMend Shoulder Spacer | G21 SRL | 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
Recalls Naming This Product
4 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Heraeus Medical LLC | 510(k) number | 2025-12-09 | Class II | Under Investigation by firm | increase of complaints regarding the breakage of the ampoules within their device systems. An extensive investigation revealed that multiple factors have an impact on the ampoule breakage. An unfortunate combination of these influence facto | ||
| Heraeus Medical LLC | 510(k) number | 2025-12-09 | Class II | Under Investigation by firm | increase of complaints regarding the breakage of the ampoules within their device systems. An extensive investigation revealed that multiple factors have an impact on the ampoule breakage. An unfortunate combination of these influence facto | ||
| Heraeus Medical LLC | 510(k) number | 2025-12-09 | Class II | Under Investigation by firm | increase of complaints regarding the breakage of the ampoules within their device systems. An extensive investigation revealed that multiple factors have an impact on the ampoule breakage. An unfortunate combination of these influence facto | ||
| Zimmer, Inc. | 510(k) number | 2013-11-04 | Class II | Other | The patient label associated with the product may be incorrect in that the lot number on the patient label may be different than the lot number on the outer carton label. | 1,534 units | 2014-10-08 |
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.