Product code LOD
- Device name
- Bone Cement
- Medical specialty
- Orthopedic
- Device class
- 2
- Regulation number
- 888.3027
- Review panel
- OR
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| N17004S013 | SURGICAL SIMPLEX P BONE CEMENT | Howmedica Corp. | 2000-12-15 |
| P970010S004 | NORIAN SRS BONE CEMENT | Synthes (Usa) | 2000-08-31 |
| N17004S012 | SURGICAL SIMPLEX P RADIOPAQUE BONE CEMENT | Howmedica Corp. | 2000-06-20 |
| P970010S002 | NORIAN SRS CEMENT | Synthes (Usa) | 2000-04-28 |
| P960001S006 | DEPUY 3 BONE CEMENT | Depuy, Inc. | 1999-09-20 |
| P960001S008 | DEPUY 1 AND ENDURANCE BONE CEMENTS | Depuy, Inc. | 1999-09-01 |
| P960001S005 | DEPUY 3 BONE CEMENT | Depuy, Inc. | 1999-08-26 |
| P970010S001 | NORIAN SRS CEMENT | Synthes (Usa) | 1999-07-16 |
| P960001S004 | DEPUY 3 BONE CEMENT | Depuy, Inc. | 1999-07-13 |
| N18466S023 | ORTHOSET BONE CEMENT | Depuy, Inc. | 1998-10-21 |
| P810020S005 | OSTEOPAL | Smith & Nephew Richards, Inc. | 1998-10-15 |
| P960001S007 | DEPUY 3 BONE CEMENT | Depuy, Inc. | 1998-08-27 |
| P810020S004 | PALACOS E-FLOW (OSTEOPAL) BONE CEMENT | Smith & Nephew Richards, Inc. | 1998-07-30 |
| N17004S011 | SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT | Howmedica Corp. | 1998-03-18 |
| P960001S003 | ENDURANCE BONE CEMENT | Depuy, Inc. | 1998-01-27 |
| N17004S010 | SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT | Howmedica Corp. | 1997-11-13 |
| P960001S001 | ENDURANCE BONE CEMENT | Depuy, Inc. | 1997-11-12 |
| N17755S048 | OSTEOBOND(TM) COPOLYMER BONE CEMENT | Zimmer, Inc. | 1997-10-28 |
| N17755S049 | OSTEOBOND(TM) COPOLYMER BONE CEMENT | Zimmer, Inc. | 1997-09-05 |
| N17004S009 | SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT | Howmedica Corp. | 1997-08-08 |
| P960001S002 | ENDURANCE BONE CEMENT | Depuy, Inc. | 1997-04-03 |
| P960001 | DEPUY 1 BONE CEMENT | Depuy, Inc. | 1997-02-11 |
| N17004S008 | SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT | Howmedica Corp. | 1996-12-18 |
| N17755S045 | ZIMMER(R) BONE CEMENT DOUGH-TYPE, ZIMMER(R) L.V.C.(R) LOW VIXCOSITY BONE CEMENT AND OSTEOBOND(TM) COPOLYMER BONE CEMENT | Zimmer, Inc. | 1996-10-17 |
| N17755S047 | OSTEOBOND(TM) COPOLYMER BONE CEMENT | Zimmer, Inc. | 1996-07-31 |
| N17004S005 | SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT | Howmedica Corp. | 1995-11-21 |
| N18466S020 | CMW BONE CEMENT, CMW 1, CMW 1 RADIOPAQUE, CMW 2, AND CMW 3 BONE CEMENTS. | Depuy, Inc. | 1995-11-20 |
| N18466S019 | CMW 1 RADIOPAQUE, CMW2 AND CMW3 BONE CEMENTS | Depuy, Inc. | 1995-11-20 |
| N17755S046 | OSTEOBOND(TM) COPOLYMER BONE CEMENT | Zimmer, Inc. | 1995-11-20 |
| N17755S044 | OSTEOBOND(TM) COPOLYMER BONE CEMENT | Zimmer, Inc. | 1995-08-11 |
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K254107 | Refobacin Bone Cement R (110034355) | Biomet France | 2026-04-15 |
| K250760 | SPECTRUM GV Bone Cement | Osteoremedies, LLC | 2025-04-02 |
| K241674 | OSTEOPAL® V | Heraeus Medical GmbH | 2024-12-05 |
| K231556 | SPECTRUM® GV Bone Cement | Osteoremedies, LLC | 2023-12-20 |
| K211163 | Bone Cement Genta, Bone Cement HV, Bone Cement LV | Tecres S.P.A. | 2023-01-09 |
| K212729 | Bone Cement-Normal Viscosity | Biomecanica Industria E Comerciode Produtos Ortopedicos Ltda | 2022-05-31 |
| K211869 | OGM 1 Polymethylmethacrylate (PMMA) bone cement, OGM 1A Polymethylmethacrylate (PMMA) bone cement | Ormed Grup Medikal Turizm Saglik Hizmetleri Sanayi VE | 2022-05-19 |
| K213812 | PALACOS MV pro | Heraeus Medical GmbH | 2022-02-02 |
| K210607 | PALACOS R pro, PALACOS R+G pro, PALACOS MV+G pro | Heraeus Medical GmbH | 2021-07-09 |
| K202458 | BonOs Inject, Pedicle screw kits, Cement pusher | Osartis GmbH | 2021-05-18 |
| K210125 | BonOs HV Genta, BonOs MV Genta, BonOs LV Genta | Osartis GmbH | 2021-03-19 |
| K210120 | BonOs HV, BonOs MV, BonOs LV | Osartis GmbH | 2021-03-19 |
| K202475 | PALACOS R, PALACOS R pro, PALACOS R+G, PALACOS R+G pro, PALACOS MV+G | Heraeus Medical GmbH | 2020-11-23 |
| K193059 | G1 40 Radiopaque Bone Cement | G21, S.R.L. | 2020-03-19 |
| K193061 | G3 40 Radiopaque Bone Cement | G21, S.R.L. | 2020-03-19 |
| K192394 | Hi-Fatigue Bone Cement | Osartis GmbH | 2019-12-02 |
| K192379 | Hi-Fatigue G Bone Cement | Osartis GmbH | 2019-11-27 |
| K190766 | PALACOS fast R+G | Heraeus Medical GmbH | 2019-05-31 |
| K181282 | G3A 40 Bone Cement | G21, S.R.L. | 2019-01-09 |
| K182260 | PALACOS MV | Heraeus Medical GmbH | 2018-09-17 |
| K173494 | OrthoSteady G Bone Cement | G21, S.R.L. | 2018-03-06 |
| K172408 | Biomet Bone Cement R | Biomet, Inc. | 2017-10-05 |
| K170802 | TRAUMACEMâ„¢ V+ Injectable Bone Cement | Synthes (USA) Products, LLC | 2017-09-28 |
| K171540 | Refobacin Bone Cement R | Biomet, Inc. | 2017-08-30 |
| K153737 | OSTEOPAL plus | Heraeus Medical GmbH | 2016-04-22 |
| K150408 | V-STEADY, V-FAST | G21, S.R.L. | 2015-12-14 |
| K150119 | PALACOS R pro | Heraeus Medical GmbH | 2015-06-17 |
| K143100 | NP Cement HV Genta;NP Cement LV Genta;NP Cement HV System Genta;NP Cement LV System Genta | Cossington, Ltd. | 2015-03-05 |
| K143134 | NP Cement HV;NP Cement LV; NP Cement HV System; NP Cement LV System | Cossington, Ltd. | 2015-03-05 |
| K142157 | PALACOS R+G PRO | Heraeus Medical GmbH | 2014-09-05 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 07613327545258 | AutoPlex VertaPlex | STRYKER CORPORATION | 2024-11-21 |
| 08031497003351 | TEKTONA HV US Bone Cement | TECRES SPA | 2023-06-08 |
| 08031497003313 | MENDEC SPINE HV | TECRES SPA | 2023-06-01 |
| 08058964720122 | G3A 40 Bone Cement | G21 SRL | 2019-03-08 |
| 08058964726759 | OrthoSteady G | G21 SRL | 2018-05-03 |
| 07613327128420 | Simplex | Howmedica Osteonics Corp. | 2017-06-19 |
| 07613327128451 | Simplex | Howmedica Osteonics Corp. | 2017-06-19 |
| 08058964723819 | V-STEADY | G21 SRL | 2017-03-29 |
| 08058964720245 | V-FAST | G21 SRL | 2017-03-29 |
| 07613154687169 | AutoPlex, VertaPlex | STRYKER CORPORATION | 2016-12-29 |
| 07613154687152 | AutoPlex, VertaPlex | STRYKER CORPORATION | 2016-12-29 |
| 07613327141764 | VertaPlex | STRYKER CORPORATION | 2016-09-23 |
| 07613154757091 | VertaPlex | STRYKER CORPORATION | 2016-06-30 |
| 10603295174271 | NA | DEPUY (IRELAND) | 2015-09-24 |
| 10603295174288 | SMARTSET | DEPUY (IRELAND) | 2015-09-24 |
| 10603295174264 | NA | DEPUY (IRELAND) | 2015-09-24 |
| 10603295168638 | NA | DEPUY (IRELAND) | 2015-09-24 |
| 10603295168621 | NA | DEPUY (IRELAND) | 2015-09-24 |
| 10603295168614 | NA | DEPUY (IRELAND) | 2015-09-24 |
| 10603295168379 | SMARTSET | DEPUY (IRELAND) | 2015-09-24 |
| 10603295168362 | SMARTSET | DEPUY (IRELAND) | 2015-09-24 |
| 10603295168355 | SMARTSET | DEPUY (IRELAND) | 2015-09-24 |
| 10603295168331 | SMARTSET | DEPUY (IRELAND) | 2015-09-24 |
| 10603295168324 | SMARTSET | DEPUY (IRELAND) | 2015-09-24 |
| 07613327128444 | Simplex | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327128437 | Simplex | Howmedica Osteonics Corp. | 2015-09-24 |
| J014002112140011 | PALACOS | Heraeus Medical GmbH | 2015-06-01 |
| J014001119140011 | PALACOS | Heraeus Medical GmbH | 2015-06-01 |
| J014001118140011 | PALACOS | Heraeus Medical GmbH | 2015-06-01 |
| J014001113140011 | PALACOS | Heraeus Medical GmbH | 2015-06-01 |