NDN · Cement, Bone, Vertebroplasty
Orthopedic · 21 CFR 888.3027 · Class 2
Overview
| Product Code | NDN |
|---|---|
| Device Name | Cement, Bone, Vertebroplasty |
| Regulation | 21 CFR 888.3027 |
| Device Class | Class 2 |
| Review Panel | Orthopedic |
| Implant | Yes |
Identification
Polymethylmethacrylate (PMMA) bone cement is a device intended to be implanted that is made from methylmethacrylate, polymethylmethacrylate, esters of methacrylic acid, or copolymers containing polymethylmethacrylate and polystyrene. The device is intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone.
Classification Rationale
Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement.”
Special Controls
*Classification.* Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement.”
Cleared Devices (108)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K251896 | XeliteMed SuperM-Fix Spinal Bone Cement | Xelite Biomed , Ltd. | Jan 28, 2026 | SESE |
| K250637 | VCFix Spinal System | Amber Implants | May 30, 2025 | SESE |
| K243537 | XeliteMed VertehighFix High Viscosity Spinal Bone Cement System | Xelite Biomed , Ltd. | Apr 11, 2025 | SESE |
| K241775 | XeliteMed VertehighFix High Viscosity Spinal Bone Cement | Xelite Biomed , Ltd. | Sep 18, 2024 | SESE |
| K232842 | Balloon Inflation System | Ningbo Hicren Biotechnology Co., Ltd. | Feb 29, 2024 | SESE |
| K240084 | V-STRUT® Vertebral Implant | Hyprevention | Feb 9, 2024 | SESE |
| K231340 | Renova Spine Balloon Catheter | Biopsybell S.R.L. | Oct 30, 2023 | SESE |
| K221697 | INJECTION PIN (KIP(02031-02061) (03031-03061)) | Slk Ortho, LLC | Mar 3, 2023 | SESE |
| K223294 | SpineJack® Expansion Kit | Stryker Instruments | Dec 20, 2022 | SESE |
| K220131 | KYPHON VuE Bone Cement | Tecres S.P.A. | Apr 18, 2022 | SESE |
| K211797 | TRACKER Plus Kyphoplasty System | GS Medical Co., Ltd. | Oct 28, 2021 | SESE |
| K211238 | SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV Radiopaque Bone Cement | Stryker Instruments | Jun 25, 2021 | SESE |
| K202393 | SpineJack Expansion Kit | Stryker Corporation | Oct 20, 2020 | SESE |
| K201831 | CONFIDENCE Spinal Cement System | Depuy Spine, Inc. | Aug 31, 2020 | SESE |
| K192449 | Joline Kyphoplasty System Allevo | Joline GmbH & Co. KG | May 27, 2020 | SESE |
| K191709 | V-STRUT Vertebral Implant | Hyprevention Sas | Mar 5, 2020 | SESE |
| K192335 | TRACKER Kyphoplasty System | GS Medical Co., Ltd. | Dec 4, 2019 | SESE |
| K192403 | VK100 Percutaneous Vertebral Augmentation System | Bonwrx, Ltd. | Nov 8, 2019 | SESE |
| K181262 | SpineJack Expansion Kit | Vexim SA | Aug 30, 2018 | SESE |
| K172871 | SpineKure Kyphoplasty System | Hanchang Co., Ltd. | May 29, 2018 | SESE |
| K180700 | KYPHON HV-R Bone Cement | Medtronic Sofamor Danek USA, Inc. | May 18, 2018 | SESE |
| K172214 | Modified Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon Catheters | G-21 S.R.L. | Aug 23, 2017 | SESE |
| K161114 | HIGH V+ | Teknimed Sas | Apr 12, 2017 | SESE |
| K163032 | Kyphon Xpede Bone Cement | Medtronic, Inc. | Feb 27, 2017 | SESE |
| K162283 | DCM Kyphoplasty System | Dragon Crown Medical Co., Ltd. | Feb 6, 2017 | SESE |
| K162618 | CONCORD Plus Radiopaque Bone Cement | Globus Medical, Inc. | Jan 23, 2017 | SESE |
| K162453 | 13G InterV Kyphoplasty Catheter (Micro) and 11G InterV Kyphoplasty Catheter (Mini-Flex) | Pan Medical , Ltd. | Nov 1, 2016 | SESE |
| K160983 | Kyphon HV-R Bone Cement | Medtronic, Inc. | Aug 24, 2016 | SESE |
| K153296 | MEDINAUT Kyphoplasty System | Imedicom Co., Ltd. | Jul 29, 2016 | SESE |
| K152557 | Winch Kyphoplasty(15 and 20 mm) 11 Gauge Balloon Catheters | G21, S.R.L. | Feb 23, 2016 | SESE |
| K151227 | KYPHON XPEDE Bone Cement | Medtronic | Nov 16, 2015 | SESE |
| K150582 | Vertaplex® High Viscosity (HV) Radiopaque Bone Cement | Stryker Corporation | Jun 12, 2015 | SESE |
| K150460 | KYPHON (R) HV-R(R) Bone Cement | Medtronic Sofamor Danck USA, Inc. | Apr 28, 2015 | SESE |
| K150607 | Osseoflex SB Straight Balloon, 10g/4ml, Osseoflex SB Straight Balloon, 10g/2ml | Osseon, LLC | Apr 9, 2015 | SESE |
| K150322 | InterV Kyphoplasty Catheter (Balloon Length: 10,15 and 20mm) InterV Kyphoplasty Catheter (Mini) (Balloon Length: 10, 15 and 20mm) | Pan Medical , Ltd. | Mar 6, 2015 | SESE |
| K143006 | GUARDIAN-SG Inflatable Bone Expander System | Bm Korea Co., Ltd. | Jan 16, 2015 | SESE |
| K141419 | ZVPLASTY | Zavation, LLC | Sep 12, 2014 | SESE |
| K141930 | OSSEOFLEX SB, 10G/4ML, OSSEOFLEX SB, 10G/2ML | Osseon, LLC | Aug 21, 2014 | SESE |
| K141141 | KIVA VCF TREATMENT SYSTEM | Benvenue Medical, Inc. | Aug 14, 2014 | SESE |
| K140937 | OSSEOFLEX SB | Osseon, LLC | Jun 19, 2014 | SESE |
| K132620 | INTER V KYPHOPLASTY CATHETER (BALLOON LENGTH: 0 MM), INTERV KYPHOPLASTY CATHETER (BALLOON LENGHT: 15 MM), INTERV KYPHOPL | Pan Medical , Ltd. | Apr 16, 2014 | SESE |
| K133669 | MEDINAUT KYPHOPLASTY SYSTEM | Imedicom | Apr 4, 2014 | SESE |
| K132817 | KIVA VCF TREATMENT SYSTEM | Benvenue Medical, Inc. | Jan 24, 2014 | SESE |
| K133372 | CROSSTREES PVA POD | Crosstrees Medical, Inc. | Dec 6, 2013 | SESE |
| K130089 | CROSSTREES PVA POD | Crosstrees Medical, Inc. | Aug 9, 2013 | SESE |
| K122503 | PARALLAX BALLOON INFLATABLE BONE TAMP-10 MM BALLOON PARALLAX BALLOON INFLATABLE BONE TAMP-15 MM BALLOON PARALLAX BALLOON | Neuro Therm, Inc. | Jun 25, 2013 | SESE |
| K130146 | SYNTHES SYNFLATE VERTEVRAL BALLOON SYSTEM | Synthes (Usa), LLC | May 20, 2013 | SESE |
| K123942 | STRYKER IVAS BALLOON CATHETER | Stryker Corporation | Apr 3, 2013 | SESE |
| K130402 | SPIDER SYSTEM KOLIBRI CEMENT NEEDLE | Sintea Plustek, LLC | Apr 1, 2013 | SESE |
| K122175 | MENDEC SPINE HV, MENDEC SPINE HV SYSTEM | Tecres S.P.A. | Mar 28, 2013 | SESE |
| K100404 | ASCENDX VCF REDUCTION SYSTEM | Aoi Medical, Inc. | Dec 14, 2012 | SESE |
| K122533 | OSSEOFLEX SB INFLATABLE BONE TAMP | Osseon Therapeutics, Inc. | Oct 23, 2012 | SESE |
| K121876 | VERTECEM II CEMENT KIT | Aap Biomaterials GmbH | Oct 19, 2012 | SESE |
| K113742 | KMC KYPHOPLASTY SYSTEM | Shanghai Kinetic Medical Co., Ltd. | Sep 17, 2012 | SESE |
| K113452 | ACU-CUT VERTEBRAL AUGMENTATION SYSTEM | Ascendx Spine, Inc. | Feb 17, 2012 | SESE |
| K113154 | IVAS BALLOON CATHETER | Stryker Corporation | Jan 24, 2012 | SESE |
| K113477 | IVAS 20MM (10 GAUGE) BALLOON CATHETER | Stryker Instruments, Instruments Div. | Jan 6, 2012 | SESE |
| K112907 | CONFIDENCE HIGH VISCOSITY SPINAL CEMENT, 16G / 20G | Medos International SARL | Dec 22, 2011 | SESE |
| K110604 | VBB SYSTEM | Synthes | Dec 13, 2011 | SESE |
| K093477 | SHIELD KYPHOPLASTY SYSTEM | Soteira, Inc. | Dec 8, 2011 | SESE |
| K111593 | GUARDIAN INFLATABLE BONE EXPANDER SYSTEM | Bm Korea Co., Ltd. | Nov 18, 2011 | SESE |
| K110998 | AFFIRM (TM) VCF SYSTEM | Algea Therapies | Oct 25, 2011 | SESE |
| K103807 | IVAS 2-10MM (10 GUAGE) BALLON CATHETER | Stryker Corporation | Jun 28, 2011 | SESE |
| K102397 | KYPHON XPEDE BONE CEMENT | Medtronic | Feb 28, 2011 | SESE |
| K110183 | ARTHROCARE PARALLAX CONTOUR VERTEBRAL AUGMENTATION DEVICE | Arthrocare Corp. | Feb 16, 2011 | SESE |
| K103816 | COHESION BONE CEMENT | Teknimed Sas | Feb 4, 2011 | SESE |
| K103064 | AVAMAX VERTEBRAL BALLOON | Care Fusion | Jan 10, 2011 | SESE |
| K103433 | F20 | Teknimed, S.A. | Jan 3, 2011 | SESE |
| K100479 | PARALLAX CONTOUR VERTEBRAL AUGMENTATION DEVICE | Arthrocare Corp. | Sep 21, 2010 | SESE |
| K093828 | KYPH X HV-R BONE CEMENT | Medtronic, Inc. | Aug 12, 2010 | SESE |
| K093419 | IVAS 2-10MM (10 GAUGE) BALLOON CATHETER, IVAS 2-15 MM(10 GAUGE)0705-115-500, IVAS 3-10MM(8 GAUGE)BALLOON CATHETER, IVAS | Stryker Instruments, Instruments Div. | Mar 18, 2010 | SESE |
| K093463 | AVAMAX VERTEBRAL BALLOON MODEL VBS1010, VBS1015, VBS1020 | Care Fusion | Feb 26, 2010 | SESE |
| K091234 | SKELTEX ISV | Skeltex Technologies, Inc. | Feb 16, 2010 | SESE |
| K090986 | STABILI ERX BONE CEMENT, MODEL 1135,STABILIT VERTEBRAL AUGMENTATION SYSTEM (FOR USE W/ STABILIT ERX BONE CEMENT) | Dfine, Inc. | Dec 30, 2009 | SESE |
| K090435 | VERTECEM | Teknimed, S.A. | Dec 21, 2009 | SESE |
| K091606 | VERTAPLEX HV (SINGLE PACK AND DUAL PACK) | Stryker Corp. | Oct 23, 2009 | SESE |
| K090211 | INFLATABLE BONE TAMP | Cardinal Health, Inc. | Jul 1, 2009 | SESE |
| K080108 | CORTOSS BONE AUGMENTATION MATERIAL | Orthovita, Inc. | Jun 5, 2009 | SESE |
| K090460 | BONOS INJECT | Aap Biomaterials GmbH | Apr 14, 2009 | SESE |
| K080873 | OPACITY + BONE CEMENT | Teknimed, S.A. | Aug 28, 2008 | SESE |
| K071375 | MESH FENESTRATED INTRODUCER NEEDLE (MESH INTRODUCER NEEDLE) | Disc-O-Tech Medical Technologies, Ltd. | Dec 21, 2007 | SESE |
| K072118 | STRYKER VERTAPLEX RADIOPAQUE BONE CEMENT | Stryker Corp. | Dec 7, 2007 | SESE |
| K071927 | MODIFICATION TO VERTEBROPLASTIC RADIOPAQUE BONE CEMENT | Depuy Spine, A Johnson & Johnson Company | Nov 21, 2007 | SESE |
| K072133 | AVAFLEX VERTEBRAL AUGMENTATION NEEDLE | Cardinal Health, Inc. | Nov 20, 2007 | SESE |
| K072496 | MODIFICATION TO SPACE CPSXL BONE CEMENT | Dfine, Inc. | Oct 5, 2007 | SESE |
| K070351 | SPACE 360 DELIVERY SYSTEM | Dfine, Inc. | Jun 29, 2007 | SESE |
| K070527 | ARCUATE VERTEBRAL AUGMENTATION SYSTEM | Medtronic Sofamor Danek | May 4, 2007 | SESE |
| K063248 | ARCUATE VERTEBRAL AUGMENTATION SYSTEM | Medtronic Sofamor Danek | Mar 13, 2007 | SESE |
| K063438 | VSPSPN | Tecres S.P.A. | Jan 17, 2007 | SESE |
| K063067 | CONFIDENCE FENESTRATED INTRODUCER NEEDLE | Disc-O-Tech Medical Technologies, Ltd. | Nov 3, 2006 | SESE |
| K062452 | KIT MENDEC SPINE AND DELIVERY SYSTEM | Tecres S.P.A. | Sep 21, 2006 | SESE |
| K062424 | CONFIDENCE EX HIGH VISCOSITY BONE CEMENT | Disc-O-Tech Medical Technologies, Ltd. | Sep 14, 2006 | SESE |
| K061531 | SPACE CPSXL BONE CEMENT | Dfine, Inc. | Aug 30, 2006 | SESE |
| K060425 | PARALLAX ACRYLIC RESIN CARTRIDGE WITH TRACERS-TA | Arthrocare Corp. | Jul 12, 2006 | SESE |
| K053336 | STAXX FX SYSTEM | Spine Wave, Inc. | Jul 3, 2006 | SESE |
| K060300 | CONFIDENCE HIGH VISCOSITY BONE CEMENT | Disc-O-Tech Medical Technologies, Ltd. | Jun 21, 2006 | SESE |
| K043593 | SPINE-FIX BIOMIMETIC BONE CEMENT | Teknimed, S.A. | Mar 17, 2006 | SESE |
| K060148 | EBI VERTEBROPLASTY SYSTEMS | Ebi, L.P. | Mar 13, 2006 | SESE |
| K053180 | PARALLAX ACRYLIC RESIN CARTRIDGE WITH TRACERS | Arthrocare Corp. | Jan 25, 2006 | SESE |
| K042691 | VERTEFIX VERTEBROPLASTY PROCEDURE SET | Cook, Inc. | Nov 8, 2005 | SESE |
| K043406 | VERTEBROPLASTIC RADIOPAQUE BONE CEMENT | Depuy Spine, Inc. | Jul 15, 2005 | SESE |
| K050864 | PARALLAX ACRYLIC RESIN WITH TRACERS TA | Arthrocare Corp. | Jun 17, 2005 | SESE |
| K042415 | MENDEC SPINE | Tecres S.P.A. | Jun 9, 2005 | SESE |
| K043518 | RADIOPAQUE BONE CEMENT | Cardinalhealth | May 11, 2005 | SESE |
| K042168 | CONCORD Radiopaque Bone Cement | Globus Medical, Inc. | Jan 14, 2005 | SESE |
| K042947 | PARALLAX ACRYLIC RESIN WITH TRACERS, MODEL KP-PAR-003 | Arthrocare Corp. | Dec 27, 2004 | SESE |
| K041584 | KYPHX HV-R BONE CEMENT, MODEL C01A | Kyphon, Inc. | Jul 7, 2004 | SESE |
| K033801 | KYPHX HV-R, MODEL C01A | Kyphon, Inc. | Apr 1, 2004 | SESE |
Top Applicants
- Arthrocare Corp. — 6 clearances
- Tecres S.P.A. — 5 clearances
- Stryker Corporation — 5 clearances
- Teknimed, S.A. — 4 clearances
- Disc-O-Tech Medical Technologies, Ltd. — 4 clearances
