BonOs HV
BonOs HV is a radiopaque acrylic bone cement used to fix artificial joint prostheses to the patient’s bone. It is supplied as two separate sterile components that are mixed to form the…
BonOs HV is a radiopaque acrylic bone cement used to fix artificial joint prostheses to the patient’s bone. It is supplied as two separate sterile components that are mixed to form the cement used during implantation.
The powder and liquid react after mixing to produce a self-hardening material. The hardened cement fixes the implant and transfers stresses to the surrounding bone. Its polymer formulation is based on methylacrylate and methylmethacrylate, with zirconium dioxide providing radiopacity.
Listed Item
BonOs® HV is a fast-setting acrylic resin for use in bone surgery. Mixing the two separate sterile components produces a ductile bone cement which, after hardening, fixes the implant. BonOs® HV cement powder also contains insoluble zirconium dioxide as an X-ray contrast medium. BonOs® HV does not emit a signal and does not pose a safety risk in a magnetic resonance environment.
Presentation
The liquid is supplied in a vial and the powder in a pouch. The components are packaged as a sterile, disposable product intended for a single use.
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 | Osartis Gmbh, Germany |
|---|---|
| FDA product code | LOD |
| Device type | Bone Cement |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3027 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| 510(k) | K210120 |
| Record published | 2024-05-17 |
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 | Special storage condition: Store between 0°C (32°F) and 25°C (77°F); Handling environment temperature 17 to 25 °C |
| Sizes | Weight 40 g |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1×40 | Weight 40 g | 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 |
|---|---|
| K202458 | 2021-05-18 |
| K210125 | 2021-03-19 |
| K210120 | 2021-03-19 |
| K192394 | 2019-12-02 |
| K192379 | 2019-11-27 |
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.