Palacos
PALACOS® fastR+G is an acrylic bone cement for use in orthopedic surgery. It is formed from powder and liquid by exothermic polymerization. It secures the fixation of the grafted artificial…
PALACOS® fastR+G is an acrylic bone cement for use in orthopedic surgery. It is formed from powder and liquid by exothermic polymerization. It secures the fixation of the grafted artificial joint improving the transfer of forces at the interface implant – bone. The antibiotic gentamicin sulphate has been added to protect the cured cement and contiguous tissue against contamination by microbes sensitive to gentamicin. PALACOS® fastR+G is available in 51 g packaging size. PALACOS® fast R+G is indicated for use as bone cement in arthroplasty procedures of the hip, knee and other joints to fix plastic and metal prosthetic parts to living bone when reconstruction is necessary. The cement is indicated for use in the second stage of a two stage revision for total joint arthroplasty after the initial infection has been cleared.
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 | LOD |
| Device type | Bone Cement |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3027 |
| Establishment | Complaint-file establishment, Manufacturer |
| 510(k) | K031673 |
| Record published | 2017-09-01 |
| Record revised | 2023-06-16 (version 8) |
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 |
| Storage | Storage environment temperature up to 25 °C |
| Packaging | Paper carton of 6, pallet of 144, shipping box of 20, pack of 400, pack of 20, pallet of 400 |
| Distribution end date | 2017-08-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| R+G | In distribution | |
| MV pro 40 | In distribution | |
| R pro 40 | In distribution | |
| MV pro 80 | In distribution | |
| MV | In distribution | |
| R | In distribution | |
| R pro 80 | In distribution | |
| LV | In distribution | |
| R pro | In distribution | |
| MV+G | In distribution | |
| fast R+G | In distribution | |
| LV | In distribution | |
| LV+G | In distribution | |
| R | In distribution | |
| MV | In distribution | |
| LV | Withdrawn | |
| R | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Kiva | Benvenue Medical, Inc. | 6 |
| Rally | Smith & Nephew, Inc. | 5 |
| Bone Cement | Depuy (Ireland) | 5 |
| PCD SpinePlex | Stryker GmbH | 4 |
| Simplex | Howmedica Osteonics Corp | 4 |
| DJO Surgical | Encore Medical, L.P. | 4 |
| Gentafix | Teknimed SAS | 3 |
| Versabond | Smith & Nephew, Inc. | 3 |
| Orthoset® | Microport Orthopedics Inc. | 3 |
| Osteopal® | Heraeus Medical LLC | 3 |
| Prostalac | Depuy Orthopaedics, Inc. | 3 |
| Signature -x Cement | Teknimed SAS | 3 |
Showing 12 of 63. All products under Bone Cement
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K241674 | 2024-12-05 |
| K213812 | 2022-02-02 |
| K210607 | 2021-07-09 |
| K202475 | 2020-11-23 |
| K190766 | 2019-05-31 |
| K182260 | 2018-09-17 |
| K153737 | 2016-04-22 |
| K150119 | 2015-06-17 |
| K142157 | 2014-09-05 |
| K030904 | 2003-09-23 |
Recalls Naming This Product
5 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 | ||
| 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 |
PMA Approvals
A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.
| PMA number | Decision | Trade name | Approved to |
|---|---|---|---|
| P970010 | 2000-08-31 | NORIAN SRS BONE CEMENT | Synthes (Usa) |
| P960001 | 1999-08-26 | DEPUY 3 BONE CEMENT | Depuy Intl., Ltd. |
| N18466 | 1998-10-21 | ORTHOSET BONE CEMENT | Depuy Intl., Ltd. |
| N17004 | 1996-12-18 | SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT | Howmedica Corp. |
| N17003 | 1993-06-08 | SURGICAL SIMPLEX(R) P BONE CEMENT | Howmedica Corp. |
| P810020 | 1992-02-14 | PALACOS R BONE CEMENT | Smith & Nephew Richards, Inc. |
| N17755 | 1990-08-02 | BONECEMENT | Zimmer, Inc. |
| N17113 | 1981-09-16 | OMNIPLASTIC BONE CEMENT | L.D. Caulk Co. |
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.