Biomet® Bone Cement R
Biomet Bone Cement R is a fast-setting acrylic cement used to fix prosthetic components to bone during joint replacement. It is indicated for plastic and metal implant parts in hip, knee…
Biomet Bone Cement R is a fast-setting acrylic cement used to fix prosthetic components to bone during joint replacement. It is indicated for plastic and metal implant parts in hip, knee and other joint arthroplasty procedures.
Mixing the powder and liquid components produces a paste that anchors the prosthesis as it hardens. The hardened cement transfers stresses from movement to the surrounding bone through its broad interface.
Visibility During Use
Zirconium dioxide in the powder makes the cement visible on X-rays. Chlorophyll in the liquid component provides visual marking of the cement at the surgical site, helping distinguish it during application.
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 | Biomet, Inc., United States |
|---|---|
| FDA product code | LOD |
| Device type | Bone Cement |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3027 |
| Establishment | Contract manufacturer, Remanufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K172408 |
| Record published | 2018-04-04 |
| Record revised | 2025-05-30 (version 4) |
Specifications
| MRI safety | MR Safe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 110035371 | In distribution | |
| 110035368 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Palacos | Heraeus Medical LLC | 17 |
| 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 |
Showing 12 of 63. All products under Bone Cement
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K172408 | 2017-10-05 |
| K171540 | 2017-08-30 |
| K092150 | 2009-10-27 |
| K051496 | 2005-08-04 |
| K051532 | 2005-08-03 |
| K030086 | 2003-12-17 |
| K993836 | 2001-12-19 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2017-04-13 | Class II | Under Investigation by firm | Six complaints were filed regarding loss of the Zimmer Biomet applied seal of a sterile Tyvek packaging. A breach in the packaging could lead to loss of sterility of the device. | 4238 | 2019-03-26 |
| 2003-01-17 | Not classified | Other | There may be cracks in the blister pack overwrap for the glass ampoule containing the liquid monomer. | 301,226 units | 2003-09-12 |
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.