ClearanceBrief
Panels › Orthopedic › Product code LOD · Class 2

Bone Cement

Regulation 888.3027

1510(k)s in 12 months (72 all time)
6recalls in 12 months (36 all time)
16recalls that name a 510(k)
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Top companies in LOD

DateFirm and productCodeLinked 510(k)
Sep 25, 2026Heraeus Medical GmbH (Dental Division)
PALACOS MV pro 40; PALACOS MV pro 80. Model/Catalog Number: 5150633; 5150635. Radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and application system, suitabl
Open, Classified
LODK213812
Sep 25, 2026Heraeus Medical GmbH (Dental Division)
PALACOS R pro 40; PALACOS R pro 80. Model/Catalog Numbers: 5081286; 5081287. Radiopaque, poly (methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and application system, suitable
Open, Classified
LODK210607
Jan 14, 2026Heraeus Medical GmbH (Dental Division)
Brand Name: PALACOS Product Name: PALACOS MV pro 40; PALACOS MV pro 80 Model/Catalog Number: 5150633; 5150635 Software Version: N/A Product Description: Radiopaque, poly(methyl methacrylate)-based (PM
Open, Classified
LODK213812
Jan 14, 2026Heraeus Medical GmbH (Dental Division)
Brand Name: PALACOS Product Name: PALACOS MV+G pro 40; PALACOS MV+G pro 80 Model/Catalog Number: 5081290; 5081291 Software Version: N/A Product Description: Radiopaque, poly(methyl methacrylate)-based
Open, Classified
LODK210607
Jan 14, 2026Heraeus Medical GmbH (Dental Division)
Brand Name: PALACOS Product Name: PALACOS R+G pro 40; PALACOS R+G pro 80 Model/Catalog Number: 5081288; 5081289 Software Version: N/A Product Description: Radiopaque, poly(methyl methacrylate)-based (
Open, Classified
LODK210607
Jan 14, 2026Heraeus Medical GmbH (Dental Division)
Brand Name: PALACOS Product Name: PALACOS R pro 40; PALACOS R pro 80 Model/Catalog Number: 5081286; 5081287 Software Version: N/A Product Description: Radiopaque, poly(methyl methacrylate)-based (PMMA
Open, Classified
LODK210607
Dec 20, 2022Howmedica Osteonics Corp.
Tobra Full Dose CE Antibiotic Simplex P- Indicated for the fixation of prostheses to living bone in orthopaedic Catalog Number:6197-1-001
Open, Classified
LODK014199
Dec 20, 2022Howmedica Osteonics Corp.
Full Dose CE Simplex P Single Bone Cement - Indicated for the fixation of prostheses to living bone in orthopaedic Catalog Number: 6191-0-001
Open, Classified
LODK002652
May 19, 2021BIOPSYBELL S.R.L.
10 GAUGE DRILL, CODE INTVM-DRL
Terminated
LODNone listed
May 19, 2021BIOPSYBELL S.R.L.
10G COAXIAL CANNULA WITH TUOHY CONNECTION, CODE INTVM-CC
Terminated
LODNone listed
May 19, 2021BIOPSYBELL S.R.L.
10G DIRECT WORKING CANNULA BEVEL TIP 15CM, CODE INTVM-DWCB/15
Terminated
LODNone listed
May 19, 2021BIOPSYBELL S.R.L.
10 GAUGE SINGLE CEMENT DELIVERY 4 FILLERS 4 SYRINGES, CODE INTVM-SCDK
Terminated
LODNone listed
May 19, 2021BIOPSYBELL S.R.L.
8G DIRECT WORKING CANNULA BEVEL TIP, CODE INTV-DWCB
Terminated
LODNone listed
May 19, 2021BIOPSYBELL S.R.L.
11G DIRECT SINGLE - ACCESS, CODE INTVMN-DSBAK
Terminated
LODNone listed
May 19, 2021BIOPSYBELL S.R.L.
11G DIRECT WORKING CANNULA DIAMOND TIP MINI, CODE INTVMN-DWCD
Terminated
LODNone listed
May 19, 2021BIOPSYBELL S.R.L.
CEMIX - CEMENT MIXING SYSTEM, CODE INTV-MMS
Terminated
LODNone listed
May 19, 2021BIOPSYBELL S.R.L.
11G DIRECT SINGLE - DELIVERY (4 FILLERS-4 SYRINGES), CODE INTVMN-SCDK
Terminated
LODNone listed
May 19, 2021BIOPSYBELL S.R.L.
8G DIRECT WORKING CANNULA BEVEL TIP, CODE INTVM-DWCB
Terminated
LODNone listed
May 19, 2021BIOPSYBELL S.R.L.
10G DIRECT SINGLE - ACCESS, CODE INTVM-DSBAK
Terminated
LODNone listed
May 19, 2021BIOPSYBELL S.R.L.
10 GAUGE CEMENT DELIVERY CANNULA, CODE INTVM-CDC
Terminated
LODNone listed
May 19, 2021BIOPSYBELL S.R.L.
10 GAUGE DIRECT UNILATERAL STYLET(1 X DIAMOND 1 X BEVEL), CODE INTVM-DSSKBD
Terminated
LODNone listed
May 19, 2021BIOPSYBELL S.R.L.
EASYNJECT, Device for cement infusion in the vertebroplasty procedure, REF KVTGUN-DS
Terminated
LODNone listed
May 19, 2021BIOPSYBELL S.R.L.
CEMENT MIXING SYSTEM, VERTEBROPLASTY-KYPHOPLASTY, REF VCF-1051
Terminated
LODNone listed
May 19, 2021BIOPSYBELL S.R.L.
BPB medica RENOVA SPINE KYPHOPLASTY WORKING CANNULA AND TROCAR TIP, 187 mm, 10G, RES RESWTR1112C-US
Terminated
LODNone listed
May 19, 2021BIOPSYBELL S.R.L.
RENOVA SPINE BONE FILLER 10G 12CM CENTIM. STERILE, RESFIL1112C1-US
Terminated
LODNone listed
May 19, 2021BIOPSYBELL S.R.L.
BPB medica CEMIX, PRODUCT NUMBER KVTMIXN, Vertebroplasty-Kyphoplasty cement mixing system
Terminated
LODNone listed
Dec 18, 2020Smith & Nephew, Inc.
VERSABOND AB 40 GRAMS FORMULATION 2, antibiotic infused bone cement, Product Number: 71271440 - Product Usage: VERSABOND is a medium viscosity bone cement which can be used for hip, knee, and shoulder
Terminated
LODK022688
Nov 9, 2017Stryker Instruments Div. of Stryker Corporation
1. AutoPlex System, Product Number: 0605-887-000, UDI: (01)4546540593108; 2. AutoPlex System: w/ VertaPlex HV, Product Number: 0607-687-000, UDI: (01)7613252039259 Bone cement.
Terminated
LODK032945
Nov 6, 2017Encore Medical, Lp
Cobalt HV with Gentamicin, Cobalt Bone Cement 40GM, REF 402283, QTY 1, STERILE, Rx Only, Mfgr: BIOMET ORTHOPEDICS Cobalt MV and HV Bone Cement is indicated for use as bone cement in arthroplastic pro
Open, Classified
LODK051496
Nov 6, 2017Encore Medical, Lp
Cobalt MV with Gentamicin, Cobalt Bone Cement 40GM, REF 402439, QTY 1, STERILE, Rx Only, Mfgr: BIOMET ORTHOPEDICS Cobalt MV and HV Bone Cement is indicated for use as bone cement in arthroplastic pro
Open, Classified
LODK091608
Nov 6, 2017Encore Medical, Lp
Cobalt MV Bone Cement 40GM, REF 402438, QTY 1, STERILE, Rx Only, Mfgr: BIOMET ORTHOPEDICS Cobalt MV and HV Bone Cement is indicated for use as bone cement in arthroplastic procedures of the hip, knee
Open, Classified
LODK091608
Nov 6, 2017Encore Medical, Lp
Cobalt HV Bone Cement 40GM, REF 402282, QTY 1, STERILE, Rx Only, Mfgr: BIOMET ORTHOPEDICS Cobalt MV and HV Bone Cement is indicated for use as bone cement in arthroplastic procedures of the hip, knee
Open, Classified
LODK051496
Apr 25, 2017Zimmer Biomet, Inc.
Cobalt HV Bone Cement Cobalt MV Bone Cement Cobalt HV Bone Cement With Gentamicin
Terminated
LODK051496
K091908
Aug 19, 2016Encore Medical, Lp
Cobalt HV Bone Cement Product Usage: Cobalt HV Bone Cement provides two separate, pre-measured and sterilized components which when mixed form a radiopaque, rapidly setting bone cement.
Terminated
LODK051496
Dec 31, 2014Zimmer, Inc.
Osteobond Bone Cement Bone cement monomer is kitted with bone cement powder to create a cement mantle for orthopedic implants.
Terminated
LODNone listed
Feb 5, 2003Biomet Inc
Palacos R radiopaque bone cement, 40 gram. Product number 424800.
Terminated
LODNone listed

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