Sobre nosotros CHANGMEI Kyphoplasty
Changmei's kyphoplasty balloon catheters have secured approximately 80% of the Chinese domestic market, establishing the company as the country's leading supplier in this category. The company also serves as a trusted OEM and supply partner to member companies of global medtech leaders Stryker and Medtronic, with products distributed across Europe, North America, and the Asia-Pacific region.
A flagship innovation is the company's 1.0mm mini biopsy forceps—the first ultra-thin biopsy forceps independently developed in China and cleared under both CE and FDA pathways. Featuring a 1.0mm jaw diameter compatible with 1.20mm instrument channels, the device incorporates a four-bar linkage structure and alligator-tooth cup design that deliver enhanced pushability and reliable tissue sampling even in narrow peripheral bronchi. This specification enables successful transbronchial biopsy in airway segments where conventional forceps cannot reach.
Backed by a cross-disciplinary team with deep expertise in medical device engineering and manufacturing processes, Changmei Medtech continues to expand its pipeline of minimally invasive solutions. The company remains committed to advancing balloon catheter and endoscopic technologies that improve clinical outcomes for patients worldwide.
Nuestros productos
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Kyphoplasty Balloon Catheter
Modelo: KB0120
Parámetros: Model: KB0120
Distance of Two Radiopaque Markers: 20 mm
Channel ID: ≥3.65 mm
Overall Length: 315 mm
Maximum Volume: 6 cc
Constrained Burst Pressure: ≥400 PSI
Size/Type: 8G
Kyphoplasty Tool Kit
Modelo: KT-00-05
Parámetros: The Changmei Kyphoplasty Tool Kit KT-00-05 is an 11G, CE-marked (CE 0123) and ISO 13485-certified PKP instrument set designed for percutaneous vertebral augmentation procedures, enabling orthopedic surgeons to establish a working channel for balloon inflation and bone cement delivery in balloon kyphoplasty (PKP) and vertebroplasty. Each sterile, single-use KT-00-05 kit contains a precisely configured instrument complement: 2 puncture expandor module (KT-07-01) for controlled tract dilation, 1 bone drill (KT-09-01) for cortical penetration, and 6 bone cement filling devices (KT-08-01) for controlled polymethylmethacrylate (PMMA) delivery into the created vertebral cavity. All components are manufactured under a TÜV SÜD-audited quality system at Changmei's 51,985 m² facility with GMP-class cleanroom production, and the kit is engineered to pair seamlessly with the company's 11G Kyphoplasty Balloon Catheter KB0210S1 (10 mm marker span, ≥3.10 mm channel ID, 280 mm length, 3 cc max volume, ≥400 PSI constrained burst pressure) and Balloon Inflator BI-20A-10 (20 cc, 30 atm). As part of the Chinese market-leading PKP system — holding approximately 80% domestic share with supply relationships to member companies of Stryker and Medtronic — the KT-00-05 supports OEM/ODM customization on gauge, length, and instrument configuration for global spine surgery centers, tertiary hospitals, and ambulatory surgery centers (ASCs).
Kyphoplasty Balloon Catheter
Modelo: KB0115S1
Parámetros: Model: KB0115S1
Distance of Two Radiopaque Markers: 15 mm
Channel ID: ≥3.10 mm
Overall Length: 280 mm
Maximum Volume: 4 cc
Constrained Burst Pressure: ≥400 PSI
Size/Type: 11G
Kyphoplasty Balloon Catheter
Modelo: KB0210S1
Parámetros: Model: KB0210S1
Distance of Two Radiopaque Markers: 10 mm
Channel ID: ≥3.10 mm
Overall Length: 280 mm
Maximum Volume: 3 cc
Constrained Burst Pressure: ≥400 PSI
Size/Type: 11G
Kyphoplasty Balloon Catheter
Modelo: KB0120S1
Parámetros: Model: KB0120S1
Distance of Two Radiopaque Markers: 20 mm
Channel ID: ≥3.10 mm
Overall Length: 280 mm
Maximum Volume: 6 cc
Constrained Burst Pressure: ≥400 PSI
Size/Type: 11G
Kyphoplasty Balloon Catheter
Modelo: KB0115
Parámetros: Model: KB0115
Distance of Two Radiopaque Markers: 15 mm
Channel ID: ≥3.65 mm
Overall Length: 315 mm
Maximum Volume: 4 cc
Constrained Burst Pressure: ≥400 PSI
Size/Type: 8G
Balloon Inflator
Modelo: BI-20A-10
Parámetros: Model: BI-20A-10
Device Class: Kyphoplasty Balloon Inflator / Balloon Inflation Pressure Pump (PKP accessory)
Nominal Capacity: 20 cc (20 ml)
Maximum Pressure: 30 atm
Syringe Feature: Supplied with 10 ml syringe (preconfigured)
Intended Use: Hydraulic pressurization of kyphoplasty balloon catheters (e.g., Changmei KB0210 8G) to dilate the vertebral body and form a cavity for bone cement injection in PKP/PVP.
Sterilization: EO sterilized, single-use
Regulatory: CE MDR certified, NMPA China Class II, FDA-cleared pathway claimed by manufacturer
Kyphoplasty Tool Kit
Modelo: KT-00-01
Parámetros: The Changmei Kyphoplasty Tool Kit KT-00-01 is an 8G, CE-marked (CE 0123) and ISO 13485-certified PKP instrument set designed for percutaneous vertebral augmentation procedures, enabling orthopedic surgeons to establish a working channel for balloon inflation and bone cement delivery in balloon kyphoplasty (PKP) and vertebroplasty. Each sterile, single-use KT-00-01 kit contains a precisely configured instrument complement: 2 puncture devices (Model KT-01-01) for initial transpedicular access, 1 puncture expandor module (KT-02-01) for controlled tract dilation, 2 expandor devices (KT-03-01) for stepwise working-channel enlargement, 1 bone drill (KT-05-01) for cortical penetration, 2 guide wires (KT-06-01) for trajectory maintenance, and 6 bone cement filling devices (KT-04-01) for controlled polymethylmethacrylate (PMMA) delivery into the created vertebral cavity. All components are manufactured under a TÜV SÜD-audited quality system at Changmei's 51,985 m² facility with GMP-class cleanroom production, and the kit is engineered to pair seamlessly with the company's 8G Kyphoplasty Balloon Catheter KB0210 (10 mm marker span, ≥3.65 mm channel ID, 315 mm length, 4 cc max volume, ≥400 PSI constrained burst pressure) and Balloon Inflator BI-20A-10 (20 cc, 30 atm). As part of the Chinese market-leading PKP system — holding approximately 80% domestic share with supply relationships to member companies of Stryker and Medtronic — the KT-00-01 supports OEM/ODM customization on gauge, length, and instrument configuration for global spine surgery centers, tertiary hospitals, and ambulatory surgery centers (ASCs).
Kyphoplasty Balloon Catheter
Modelo: KB0210
Parámetros: Model: KB0210
Distance of Two Radiopaque Markers: 10 mm
Channel ID: ≥3.65 mm
Overall Length: 315 mm
Maximum Volume: 4 cc
Constrained Burst Pressure: ≥400 PSI
Size/Type: 8G
Galería de la empresa
Certificaciones y premios
Casos de éxito
Our customers include medical device distributors, importers, and agents worldwide; hospital groups and orthopedic/spine departments; ambulatory surgical centers (ASCs); group purchasing organizations (GPOs); and OEM/ODM partners. We hold ~80% share of the Chinese kyphoplasty balloon catheter market, operate with contract manufacturing partners in Europe, and supply as a qualified vendor to member companies of Medtronic and Stryker.
Balloon kyphoplasty delivers rapid and sustained pain relief, with clinical studies reporting significant VAS score reduction within 24–48 hours post-procedure. The balloon inflation mechanism restores 30%–50% of lost vertebral body height on average and corrects local kyphotic deformity, improving spinal alignment. PMMA cement forms an internal cast that provides immediate mechanical stability, preventing further vertebral collapse. Patients typically ambulate within 24 hours and are discharged within 1–2 days, enabling faster return to daily activities compared with prolonged conservative therapy. Cement leakage rates are significantly lower than traditional vertebroplasty due to controlled low-pressure cavity filling. Long-term outcomes include improved quality of life, reduced need for opioid analgesia, and lower rates of fracture-related complications.
Changmei PKP systems stand out with a proprietary four-wing folding balloon catheter that expands uniformly to create a well-defined intracorporal cavity, enabling effective vertebral height restoration and kyphosis correction. The balloon withstands ≥400 psi burst pressure for reliable performance across 10/15/20 mm diameters. Backed by ISO 13485, CE, and US FDA 510(k) certifications, our products hold ~80% of China's domestic PKP balloon catheter market and are supplied to member companies of Medtronic and Stryker. With an annual production capacity of 1,000,000 balloon catheters and flexible OEM/ODM support, Changmei delivers proven quality, scalable supply, and competitive pricing for global distributors and healthcare providers.
Videos de la empresa y productos
Introducción a la empresa y tour por la fábrica
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Demostración del producto - Kestrel K-1
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showcase de innovación tecnológica
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Testimonios de clientes y casos de éxito
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