Kyphoplasty Balloon Catheter

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

No FDA recalls found in the data synced 22 Oct 2026.

Generic Name

Kyphoplasty balloon catheter

Model / Reference

KB0210, KB0115, KB0115S1

Primary DI / UDI-DI

06923558500812 EUDAMED

06923558504193 EUDAMED

06923558504162 EUDAMED

06923558507385 GUDID

Basic UDI-DI

69235585KB04CEBG8, 69235585KB04CEAG6

510(k) Number

K223709 ↗

FDA Product Code

HRX, HXG

EMDN Code

P099002 Orthopaedic cement preparation and application devices and kits

GMDN Term

Kyphoplasty balloon catheter

Device Class

Class IIa EUDAMED

Class II 510(k)GUDID

Regulation

21 CFR Part 888.1100 510(k)GUDID

888.4540 GUDID

EU market of registration

Greece

Germany

Türkiye

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

GUDID distribution status

In Commercial Distribution

• Dilation Balloon Catheter

  Class IIa

  CE/MDD

• Bougie Dilator Sets

  Class IIa

  CE/MDD

• Kyphoplasty Tool Kit

  Class IIa

  CE/MDR

• Kyphoplasty Tool Kit KT-00-06

  Class I

  GUDID on market

• Kyphoplasty Balloon Catheter KB0210S1

  Class II

  CE/MDR GUDID on market

• Kyphoplasty Balloon Catheter

  Class IIa

  CE/MDR GUDID on market

See all devices from Jiangsu Changmei Medtech Co., Ltd. →

• What clinical procedure is the Kyphoplasty Balloon Catheter specifically designed for, and how does it function during that procedure?

  The Kyphoplasty Balloon Catheter is designed for vertebral augmentation during kyphoplasty procedures. It is inserted into a fractured vertebra where it is then inflated to restore vertebral height and stability, creating a cavity that allows bone cement to be injected. This process helps stabilize the spine and alleviate pain caused by vertebral compression fractures.

• Is the Kyphoplasty Balloon Catheter reusable, and if not, what are the proper storage instructions to maintain its sterility?

  The Kyphoplasty Balloon Catheter is intended for single-use only and is supplied sterile. To maintain sterility, it should be stored in its original packaging, away from direct sunlight, extreme temperatures, and moisture, following standard sterile medical device storage protocols. Avoid contamination by keeping the packaging sealed until immediate use.

• What regulatory pathways has the Kyphoplasty Balloon Catheter undergone, and what does this mean for its use in clinical settings?

  The Kyphoplasty Balloon Catheter has received FDA 510(k) clearance under the Traditional pathway and MDR (Medical Device Regulation) authorization in the EU. This means it has been evaluated by regulatory authorities for safety and effectiveness, confirming its compliance with applicable standards for vertebral augmentation procedures. Clinicians can rely on its regulatory approvals as evidence of its intended use and performance.

• Are there different sizes available for the Kyphoplasty Balloon Catheter, and how would a clinician determine the appropriate size for a patient?

  Yes, the Kyphoplasty Balloon Catheter is available in multiple sizes, as specified in the manufacturer’s documentation. The correct size depends on the specific vertebral anatomy and fracture characteristics of the patient. Clinicians should refer to the manufacturer’s sizing guidelines, imaging results, and procedural planning to select the appropriate catheter size for optimal performance during kyphoplasty.