Kyphoplasty Balloon Catheter

Product Specification

Feature

The Changmei Kyphoplasty Balloon Catheter KB0115S1 (11G)​ 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 KB0115S1 specifies a distance of two radiopaque markers of 15 mm, a channel inner diameter of ≥3.10 mm, an overall length of 280 mm, a maximum inflation volume of 4 cc, and a constrained burst pressure of ≥400 PSI, positioning it as the core 15 mm balloon in Changmei's 11G PKP catheter family alongside the 10 mm KB0210S1 and 20 mm KB0120S1. 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 KB0115S1 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-00-05 11G tool kit and BI-20A-10 balloon inflator (20 cc, 30 atm) as one interoperable vertebral augmentation system . Clinically, the KB0115S1 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.