Osteopal®
The listed plus model is OSTEOPAL plus, a radiopaque, low-viscosity polymethyl methacrylate bone cement. Its filing describes use to fill and stabilize vertebral bodies. The stated…
The listed plus model is OSTEOPAL plus, a radiopaque, low-viscosity polymethyl methacrylate bone cement. Its filing describes use to fill and stabilize vertebral bodies.
The stated indication is treatment of pathological vertebral-body fractures due to osteoporosis, cancer or benign lesions using vertebroplasty or balloon kyphoplasty.
Listed Item
OSTEOPAL® V is a standard-setting, low-viscosity, radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement. It contains the X-ray contrast medium zirconium dioxide. To improve visibility in the surgical field, it has been colored with chlorophyll-copper-complex (E141). The bone cement consists of two components and is prepared immediately before use by mixing the polymer powder with the monomer liquid. The low viscosity increases with progressing polymerization. A paste forms that is inserted into the vertebral body using an application system and sets within a few minutes. OSTEOPAL® V is intended for single use and is supplied sterile.
Preparation and Placement
The filing describes preparing the cement immediately before use by mixing polymer powder and liquid monomer. The resulting paste is applied with an application system, placed in the vertebral body and allowed to cure.
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) | K153737 |
| Record published | 2020-08-10 |
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 |
| Packaging | Carton of 20, pallet of 400 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| plus | In distribution | |
| V | In distribution | |
| V | 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 |
| 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
4 of these are 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 |
|---|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
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.