FDA.reportPublic FDA data

Inflatable bone tamp

Definition
A catheter-like device with an inflatable balloon at the distal end used for the reduction of fractures and/or creation of a void in cancellous bone [e.g., in the spine for a vertebral compression fracture (VCF), hand, tibia, radius, and calcaneus]. It is commonly used for kyphoplasty, which involves its insertion into a patient's back to reduce a vertebral body fracture by compression of cancellous bone and/or movement of the endplates as the balloon is inflated. After the device is removed, orthopaedic bone cement is introduced into the created void to stabilize the vertebra. This is a single-use device.
GUDID devices
247
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00763000311902KYPHON Xpander™ Inflatable Bone TampMEDTRONIC SOFAMOR DANEK, INC.K08A2020-11-06
00763000311919KYPHON Xpander™ Inflatable Bone TampMEDTRONIC SOFAMOR DANEK, INC.K09A2020-11-06
00763000311926KYPHON Xpander™ Inflatable Bone TampMEDTRONIC SOFAMOR DANEK, INC.K13A2020-11-06
00763000311933KYPHON Xpander™ II Inflatable Bone TampMEDTRONIC SOFAMOR DANEK, INC.KX1032020-11-06
00763000311957KYPHON Xpander™ II Inflatable Bone TampMEDTRONIC SOFAMOR DANEK, INC.KX1532020-11-06
00763000311971KYPHON Xpander™ II Inflatable Bone TampMEDTRONIC SOFAMOR DANEK, INC.KX2032020-11-06
00884450386743Osseoflex®Merit Medical Systems, Inc.008844503867432019-06-24
00884450386750Osseoflex®Merit Medical Systems, Inc.008844503867502019-06-24
00884450387399Osseoflex®Merit Medical Systems, Inc.008844503873992019-09-11
00884450387429Osseoflex®Merit Medical Systems, Inc.008844503874292019-08-19
00884450447109Arcadia™Merit Medical Systems, Inc.008844504471092020-01-28
00884450447130Arcadia™Merit Medical Systems, Inc.008844504471302020-07-02
00884450447161Arcadia™Merit Medical Systems, Inc.008844504471612020-01-22
00884450447192Arcadia™Merit Medical Systems, Inc.008844504471922020-03-26
00884450447222Arcadia™Merit Medical Systems, Inc.008844504472222020-01-22
00884450447253Arcadia™Merit Medical Systems, Inc.008844504472532020-01-29
00884450447284Arcadia™Merit Medical Systems, Inc.008844504472842020-01-31
00884450447314Arcadia™Merit Medical Systems, Inc.008844504473142020-04-01
00884450447345Arcadia™Merit Medical Systems, Inc.008844504473452020-01-31
00884450447376Arcadia™Merit Medical Systems, Inc.008844504473762020-01-29
00884450490853Arcadia™Merit Medical Systems, Inc.008844504908532020-09-18
00884450490860Arcadia™Merit Medical Systems, Inc.008844504908602020-09-17
00884450490877Arcadia™Merit Medical Systems, Inc.008844504908772020-09-11
00884450490884Arcadia™Merit Medical Systems, Inc.008844504908842020-08-31
00884450490891Arcadia™Merit Medical Systems, Inc.008844504908912020-09-11
00884450547564Arcadia™Merit Medical Systems, Inc.008844505475642022-09-16
00884450780305Arcadia™Merit Medical Systems, Inc.F2026-04-29
00884450838341KyphoFlex™Merit Medical Systems, Inc.Initial Release2024-09-05
00884450838358KyphoFlex™Merit Medical Systems, Inc.Initial Release2024-09-05
00884450845301KyphoFlex™Merit Medical Systems, Inc.Initial Release2024-10-25
00884450845318KyphoFlex™Merit Medical Systems, Inc.Initial Release2024-10-25
00884450845325KyphoFlex™Merit Medical Systems, Inc.Initial Release2024-10-25
07613252052029iVASSTRYKER CORPORATION07051155002015-09-24
07613252163626iVASSTRYKER CORPORATION07051105002015-09-24
07613252293170iVASSTRYKER CORPORATION07051205002015-09-24
07613252505976iVASSTRYKER CORPORATION07053155002015-09-24
07613252506003iVASSTRYKER CORPORATION07053105002015-09-24
07613327142723iVASSTRYKER CORPORATION8080105002019-01-11
07613327142730iVASSTRYKER CORPORATION8080155002018-03-08
07613327142747iVASSTRYKER CORPORATION8081105002019-01-11
07613327142754iVASSTRYKER CORPORATION8080205002019-01-11
07613327142761iVASSTRYKER CORPORATION8081155002018-03-08
08058964726766Winch Kyphoplasty ( 15 mm) 11 Gauge Balloon CatheterG21 SRL9000272017-11-13
08058964726773Winch Kyphoplasty ( 20 mm) 11 Gauge Balloon CatheterG21 SRL9000282017-11-13
08809317170060B-Two Inflatable bone expander system balloon catheterIMEDICOM CO., LTD.US1020102016-09-27
08809317170350MEDINAUT-X(IBE System)IMEDICOM CO., LTD.IBE-102016-09-27
08809317170367MEDINAUT-X(IBE System)IMEDICOM CO., LTD.IBE-152016-09-27
08809317170374MEDINAUT-X(IBE System)IMEDICOM CO., LTD.IBE-202016-09-27
08809317170404B-Two Inflatable bone expander system balloon catheterIMEDICOM CO., LTD.US1020152016-09-27
08809317170411B-Two Inflatable bone expander system balloon catheterIMEDICOM CO., LTD.US1020202016-09-27
08809544175180MEDINAUT Plus Kyphoplasty SystemIMEDICOM CO., LTD.PIBE-102019-05-31
08809544175197MEDINAUT Plus Kyphoplasty SystemIMEDICOM CO., LTD.PIBE-152019-05-31
08809544175203MEDINAUT Plus Kyphoplasty SystemIMEDICOM CO., LTD.PIBE-202019-05-31
10705034722603VBBSynthes GmbH03.804.500S2015-09-14
10705034722610VBBSynthes GmbH03.804.501S2015-09-14
10705034722627VBBSynthes GmbH03.804.502S2015-09-14
10705034722702SYNFLATESynthes GmbH03.804.700S2015-09-14
10705034722719SYNFLATESynthes GmbH03.804.701S2015-09-14
10705034722726SYNFLATESynthes GmbH03.804.702S2015-09-14
00884450815465Arcadia™Merit Medical Systems, Inc.F2025-04-18
00884450815441Arcadia™Merit Medical Systems, Inc.G2025-04-15
00884450815724Arcadia™Merit Medical Systems, Inc.F2025-04-11
00884450815496Arcadia™Merit Medical Systems, Inc.F2025-04-10
00884450790502Arcadia™Merit Medical Systems, Inc.D2025-03-24
00884450790564Arcadia™Merit Medical Systems, Inc.D2025-03-07
00884450815526Arcadia™Merit Medical Systems, Inc.F2025-03-07
00884450790410Arcadia™Merit Medical Systems, Inc.D2025-03-06
00884450790533Arcadia™Merit Medical Systems, Inc.D2025-03-06
00884450790557Arcadia™Merit Medical Systems, Inc.D2025-03-06
00884450790779Arcadia™Merit Medical Systems, Inc.D2025-03-06
00884450815786Arcadia™Merit Medical Systems, Inc.G2025-03-01
00884450815519Arcadia™Merit Medical Systems, Inc.G2025-01-24
00884450815359Arcadia™Merit Medical Systems, Inc.G2025-01-15
00884450815717Arcadia™Merit Medical Systems, Inc.G2025-01-15
00884450815748Arcadia™Merit Medical Systems, Inc.G2025-01-15
00884450815489Arcadia™Merit Medical Systems, Inc.G2024-11-26
00884450815540Arcadia™Merit Medical Systems, Inc.G2024-11-26
00884450780138Arcadia™Merit Medical Systems, Inc.F2024-11-02
10884450845308KyphoFlex™Merit Medical Systems, Inc.Initial Release2024-10-25
10884450845315KyphoFlex™Merit Medical Systems, Inc.Initial Release2024-10-25