Kyphoplasty Balloon Catheter

Product Specification

Feature

The Changmei Kyphoplasty Balloon Catheter KB0120 (8G)​ is a single-use, CE-MDR marked and ISO 13485-certified inflatable bone tamp intended for percutaneous balloon kyphoplasty (PKP) to reduce and fix vertebral fractures and create a void in cancellous bone for subsequent PMMA bone cement injection, with U.S. market authorization under FDA 510(k) clearance (K223709, Product Code HRX, Class II, 21 CFR 888.1100, cleared August 16, 2023)​ . The KB0120 specifies a distance of two radiopaque markers of 20 mm, a channel inner diameter of ≥3.65 mm, an overall length of 315 mm, a maximum inflation volume of 6 cc, and a constrained burst pressure of ≥400 PSI, positioning it as the core 20 mm balloon in Changmei's 8G PKP catheter family alongside the 10 mm KB0210 and 15 mm KB0150. The balloon film is constructed from medical-grade thermoplastic polyurethane (TPU) using a standard four-wing pleating process that delivers radial support, biocompatibility, environmental stress-crack resistance, and smooth passability through the trocar after deflation, while a tantalum (Ta) radiopaque marker band and PU shaft with 06Cr19Ni10 stainless-steel stylet reinforcement provide fluoroscopic visibility and pushability . Every KB0120 unit is ethylene-oxide sterilized, validated for a 3-year shelf life, and passes factory pressure and seal testing to minimize intraoperative burst or leakage risk, and the catheter is engineered to pair with the Changmei KT-00-01 8G tool kit and BI-20A-10 balloon inflator (20 cc, 30 atm) as one interoperable vertebral augmentation system . Clinically, the KB0120 enables controlled cavity creation, restoration of lost vertebral height, correction of kyphotic deformity, and reduced cement leakage under local anesthesia, backed by Changmei's position as the Chinese PKP balloon market leader with approximately 80% domestic share and supply relationships to member companies of Stryker and Medtronic.