LOD · Class II · 21 CFR 888.3027

FDA Product Code LOD: Bone Cement

Leading manufacturers include DePuy Orthopaedics, Inc., Biomet, Inc. and Heraeus Medical GmbH.

72
Total
72
Cleared
167d
Avg days
2000
Since
Growing category - 3 submissions in the last 2 years vs 2 in the prior period
Review times improving: avg 105d recently vs 169d historically

FDA 510(k) Cleared Bone Cement Devices (Product Code LOD)

72 devices
1–24 of 72
Cleared Apr 15, 2026
Refobacin Bone Cement R (110034355)
K254107
Biomet France
Orthopedic · 117d
Cleared Apr 02, 2025
SPECTRUM GV Bone Cement
K250760
Osteoremedies, LLC
Orthopedic · 20d
Cleared Dec 05, 2024
OSTEOPAL® V
K241674
Heraeus Medical GmbH
Orthopedic · 177d
Cleared Dec 20, 2023
SPECTRUM® GV Bone Cement
K231556
Osteoremedies, LLC
Orthopedic · 204d
Cleared Jan 09, 2023
Bone Cement Genta, Bone Cement HV, Bone Cement LV
K211163
Tecres S.P.A.
Orthopedic · 630d
Cleared May 31, 2022
Bone Cement-Normal Viscosity
K212729
Biomecanica Industria E Comerciode Produtos Ortopedicos Ltda
Orthopedic · 277d
Cleared May 19, 2022
OGM 1 Polymethylmethacrylate (PMMA) bone cement, OGM 1A Polymethylmethacrylate (PMMA) bone cement
K211869
Ormed Grup Medikal Turizm Saglik Hizmetleri Sanayi VE
Orthopedic · 337d
Cleared Feb 02, 2022
PALACOS MV pro
K213812
Heraeus Medical GmbH
Orthopedic · 57d
Cleared Jul 09, 2021
PALACOS R pro, PALACOS R+G pro, PALACOS MV+G pro
K210607
Heraeus Medical GmbH
Orthopedic · 130d
Cleared May 18, 2021
BonOs Inject, Pedicle screw kits, Cement pusher
K202458
Osartis GmbH
Orthopedic · 264d
Cleared Mar 19, 2021
BonOs HV, BonOs MV, BonOs LV
K210120
Osartis GmbH
Orthopedic · 59d
Cleared Mar 19, 2021
BonOs HV Genta, BonOs MV Genta, BonOs LV Genta
K210125
Osartis GmbH
Orthopedic · 59d
Cleared Nov 23, 2020
PALACOS R, PALACOS R pro, PALACOS R+G, PALACOS R+G pro, PALACOS MV+G
K202475
Heraeus Medical GmbH
Orthopedic · 87d
Cleared Mar 19, 2020
G1 40 Radiopaque Bone Cement
K193059
G21, S.R.L.
Orthopedic · 139d
Cleared Mar 19, 2020
G3 40 Radiopaque Bone Cement
K193061
G21, S.R.L.
Orthopedic · 139d
Cleared Dec 02, 2019
Hi-Fatigue Bone Cement
K192394
Osartis GmbH
Orthopedic · 90d
Cleared Nov 27, 2019
Hi-Fatigue G Bone Cement
K192379
Osartis GmbH
Orthopedic · 89d
Cleared May 31, 2019
PALACOS fast R+G
K190766
Heraeus Medical GmbH
Orthopedic · 67d
Cleared Jan 09, 2019
G3A 40 Bone Cement
K181282
G21, S.R.L.
Orthopedic · 239d
Cleared Sep 17, 2018
PALACOS MV
K182260
Heraeus Medical GmbH
Orthopedic · 27d
Cleared Mar 06, 2018
OrthoSteady G Bone Cement
K173494
G21, S.R.L.
Orthopedic · 113d
Cleared Oct 05, 2017
Biomet Bone Cement R
K172408
Biomet, Inc.
Orthopedic · 57d
Cleared Aug 30, 2017
Refobacin Bone Cement R
K171540
Biomet, Inc.
Orthopedic · 96d
Cleared Oct 27, 2009
COBALT MV WITH GENTAMICIN (AKA COBALT G-MV) BONE CEMENT
K092150
Biomet, Inc.
Orthopedic · 103d

About Product Code LOD - Regulatory Context

510(k) Submission Activity

72 total 510(k) submissions under product code LOD since 2000, with 72 receiving FDA clearance (average review time: 167 days).

Submission volume has increased in recent years - 3 submissions in the last 24 months compared to 2 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - LOD Product Code

Recent submissions under LOD have taken an average of 105 days to reach a decision - down from 169 days historically, suggesting improved FDA processing for this classification.

LOD devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →