About 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.
Our Products
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CE-MDR and FDA 510(k) Cleared Kyphoplasty Balloon Catheter 8G 20mm
Model: KB0120
Parameters: 5044593885
CE-Certified 11G Kyphoplasty Tool Kit KT-00-05 with 9-Piece Sterile Single-Use PKP Instrument Set
Model: KT-00-05
Parameters: 0849888948
Changmei Kyphoplasty Balloon Catheter 11G 15mm Markers Medical-Grade TPU
Model: KB0115S1
Parameters: 7455041918
Single-Use 10mm Kyphoplasty Balloon Catheter KB0210S1 11G CE FDA 510(k)
Model: KB0210S1
Parameters: 769732203X
20mm 6cc Reinforced Kyphoplasty Balloon Catheter 11G KB0120S1
Model: KB0120S1
Parameters: 6393071397
15mm 8G Kyphoplasty Balloon Catheter for Vertebral Augmentation
Model: KB0115
Parameters: 7836134865
FDA-Cleared 15mm Kyphoplasty Balloon Catheter for Vertebral Compression Fractures
Model: KB0115
Parameters: 0037043587
Changmei Single-Use Balloon Inflator 20cc 30atm for Kyphoplasty
Model: BI-20A-10
Parameters: 5490059184
CE-MDR Certified 20cc 30atm Kyphoplasty Balloon Inflator with 10ml Syringe
Model: BI-20A-10
Parameters: 9022097595
CE-Certified 14-Piece Kyphoplasty Tool Kit KT-00-01 for Percutaneous Vertebral Augmentation
Model: KT-00-01
Parameters: 1869947908
Company Gallery
Certifications & Awards
Success Stories & Case Studies
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.
Company & Product Videos
Company Introduction & Factory Tour
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Product Demonstration - Kestrel K-1
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Technology Innovation Showcase
⏱ Duration: 4:30 | 👁 Views: 12,890
Customer Testimonials & Success Stories
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