Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
LOD — Predicate Candidate Screening
72 FDA 510(k) clearances under this product code; the 50 most recent screened below.
128 daysmedian FDA review time
337 days90th percentile
72clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K254107 | Refobacin Bone Cement R (110034355) | Biomet France | 2026-04-15 | 117 | 0 |
| K250760 | SPECTRUM GV Bone Cement | Osteoremedies, LLC | 2025-04-02 | 20 | 0 |
| K241674 | OSTEOPAL® V | Heraeus Medical GmbH | 2024-12-05 | 177 | 0 |
| K231556 | SPECTRUM® GV Bone Cement | Osteoremedies, LLC | 2023-12-20 | 204 | 0 |
| K211163 | Bone Cement Genta, Bone Cement HV, Bone Cement LV | Tecres S.P.A. | 2023-01-09 | 630 | 0 |
| K212729 | Bone Cement-Normal Viscosity | Biomecanica Industria E Comerciode Produtos Ortopedicos Ltda | 2022-05-31 | 277 | 0 |
| K211869 | OGM 1 Polymethylmethacrylate (PMMA) bone cement, OGM 1A Poly | Ormed Grup Medikal Turizm Saglik Hizmetleri Sanayi VE | 2022-05-19 | 337 | 0 |
| K213812 | PALACOS MV pro | Heraeus Medical GmbH | 2022-02-02 | 57 | 1 |
| K210607 | PALACOS R pro, PALACOS R+G pro, PALACOS MV+G pro | Heraeus Medical GmbH | 2021-07-09 | 130 | 3 |
| K202458 | BonOs Inject, Pedicle screw kits, Cement pusher | Osartis GmbH | 2021-05-18 | 264 | 0 |
| K210125 | BonOs HV Genta, BonOs MV Genta, BonOs LV Genta | Osartis GmbH | 2021-03-19 | 59 | 0 |
| K210120 | BonOs HV, BonOs MV, BonOs LV | Osartis GmbH | 2021-03-19 | 59 | 0 |
| K202475 | PALACOS R, PALACOS R pro, PALACOS R+G, PALACOS R+G pro, PALA | Heraeus Medical GmbH | 2020-11-23 | 87 | 0 |
| K193061 | G3 40 Radiopaque Bone Cement | G21, S.R.L. | 2020-03-19 | 139 | 0 |
| K193059 | G1 40 Radiopaque Bone Cement | G21, S.R.L. | 2020-03-19 | 139 | 0 |
| K192394 | Hi-Fatigue Bone Cement | Osartis GmbH | 2019-12-02 | 90 | 0 |
| K192379 | Hi-Fatigue G Bone Cement | Osartis GmbH | 2019-11-27 | 89 | 0 |
| K190766 | PALACOS fast R+G | Heraeus Medical GmbH | 2019-05-31 | 67 | 0 |
| K181282 | G3A 40 Bone Cement | G21, S.R.L. | 2019-01-09 | 239 | 0 |
| K182260 | PALACOS MV | Heraeus Medical GmbH | 2018-09-17 | 27 | 0 |
| K173494 | OrthoSteady G Bone Cement | G21, S.R.L. | 2018-03-06 | 113 | 0 |
| K172408 | Biomet Bone Cement R | Biomet, Inc. | 2017-10-05 | 57 | 0 |
| K170802 | TRAUMACEM™ V+ Injectable Bone Cement | Synthes (USA) Products, LLC | 2017-09-28 | 195 | 0 |
| K171540 | Refobacin Bone Cement R | Biomet, Inc. | 2017-08-30 | 96 | 0 |
| K153737 | OSTEOPAL plus | Heraeus Medical GmbH | 2016-04-22 | 116 | 0 |
| K150408 | V-STEADY, V-FAST | G21, S.R.L. | 2015-12-14 | 299 | 0 |
| K150119 | PALACOS R pro | Heraeus Medical GmbH | 2015-06-17 | 148 | 0 |
| K143134 | NP Cement HV;NP Cement LV; NP Cement HV System; NP Cement LV | Cossington, Ltd. | 2015-03-05 | 125 | 0 |
| K143100 | NP Cement HV Genta;NP Cement LV Genta;NP Cement HV System Ge | Cossington, Ltd. | 2015-03-05 | 128 | 0 |
| K142157 | PALACOS R+G PRO | Heraeus Medical GmbH | 2014-09-05 | 30 | 0 |
| K123225 | BONOS R 1X20, BONOS R 2X20, BONOS R 1X40, BONOS R 2X40, BONO | Aap Biomaterials GmbH & Co. KG | 2013-03-15 | 151 | 0 |
| K123081 | BONOS R GENTA 1X20 MODEL 01-0228; BONOS R GENTA 2X20 MODEL 0 | Aap Biomaterials GmbH & Co. KG | 2013-03-07 | 157 | 1 |
| K092773 | CEMEX GENTA, GENTA SYSTEM AND GENTA SYSTEM FAST | Tecres S.P.A. | 2009-11-24 | 76 | 0 |
| K092150 | COBALT MV WITH GENTAMICIN (AKA COBALT G-MV) BONE CEMENT | Biomet, Inc. | 2009-10-27 | 103 | 0 |
| K091608 | COBALT MV BONE CEMENT | Biomet Manufacturing Corp | 2009-09-17 | 106 | 2 |
| K081155 | SMARTSET MV BONE CEMENT | DePuy Orthopaedics, Inc. | 2008-05-14 | 21 | 0 |
| K070015 | COBALT V RADIOPAQUE VERTEBROPLASTY BONE CEMENT | Biomet Manufacturing Corp | 2007-11-30 | 331 | 0 |
| K062553 | SIMPLEX P BONE CEMENT | Stryker Orthopaedics | 2007-01-08 | 131 | 0 |
| K053198 | SIMPLEX P SPEEDSET BONE CEMENT | Howmedica Osteonics Corp. | 2006-01-26 | 71 | 0 |
| K053445 | SMARTMIX CEMVAC PRE-FILLED WITH SMARTSET HV BONE CEMENT | DePuy Orthopaedics, Inc. | 2006-01-06 | 25 | 0 |
| K053003 | DEPUY CMW 1, 2 AND 3 BONE CEMENTS | DePuy Orthopaedics, Inc. | 2005-11-22 | 27 | 0 |
| K050085 | OSTEOPAL V | Heraeus Kulzer,GmbH | 2005-09-14 | 244 | 0 |
| K051496 | COBALT BONE CEMENT | Biomet, Inc. | 2005-08-04 | 59 | 4 |
| K051532 | COBALT G HV BONE CEMENT | Biomet, Inc. | 2005-08-03 | 55 | 0 |
| K050854 | PALACOS LV+G | Heraeus Kulzer,GmbH | 2005-07-07 | 94 | 0 |
| K050855 | PALAMED G | Heraeus Kulzer,GmbH | 2005-07-07 | 94 | 0 |
| K043403 | CEMEX SYSTEM GENTA FAST BONE CEMENT | Exactech, Inc. | 2004-12-28 | 18 | 0 |
| K041656 | MODIFICATION TO DEPUY 1 GENTAMICIN BONE CEMENT AND SMARTSET | DePuy Orthopaedics, Inc. | 2004-07-01 | 13 | 0 |
| K031673 | REFOBACIN -PALACOS G | Heraeus Kulzer GmbH & Co. KG | 2004-05-25 | 361 | 1 |
| K032945 | SIMPLEX X | Stryker Corp. | 2004-05-25 | 246 | 1 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda