Kyphoplasty Tool Kit

Name: "Kyphoplasty Tool Kit"
Rating: 5 (771 reviews)

SKU: 4559522901

Modelo: KT-00-05

CHANGMEI Kyphoplasty

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Product Specification

Type	Vertebral Augmentation Instrument Set	Model	KT-00-05
Params	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).	Material	The Changmei Kyphoplasty Tool Kit KT-00-05 uses 06Cr19Ni10 medical-grade stainless steel for most metal parts (cannulas, expandor shafts, bone drill body, guide wire core) and 32Cr13Mo stainless steel for the puncture stylet and puncture expandor cutting tips.
Applicable Industry	Orthopedic Surgery, Spine Surgery, Pain Management, Interventional Pain Clinics

Feature

The Changmei Kyphoplasty Tool Kit KT-00-05 is an 11G, CE-marked (CE 0123) and ISO 13485-certified, EO-sterilized single-use PKP instrument set for percutaneous vertebral augmentation, giving orthopedic and spine surgeons a complete working-channel toolkit to access the pedicle, dilate the tract, drill the cortical bone, and deliver PMMA bone cement in balloon kyphoplasty. Each KT-00-01 packs a balanced 9-piece instrument loadout—2 puncture expandor module (KT-02-01) for tract dilation, 1 bone drill (KT-09-01) with 06Cr19Ni10 / 32Cr13Mo stainless steel cutting tip, and 6 bone cement filling devices (KT-08-01) to support controlled, low-leakage cement injection across multiple fills. Metal shafts use medical-grade stainless steel (GB 1220 compliant) with ABS/polymer handles, all joints rated ≥100 N connection strength, so the kit survives tight pedicular navigation without disassembly or blockage. Clinically, the KT-00-05 shortens PKP setup time under local anesthesia, reduces soft-tissue trauma and blood loss versus open spine exposure, and pairs natively with Changmei’s KB0210S1 11G balloon catheter (≥400 PSI, 3 cc, 280 mm) and BI-20A-10 inflator (30 atm) to form one interoperable 11G system. Manufactured in Changmei’s 51,985 m² Changzhou facility with GMP-class cleanroom and TÜV SÜD-audited QMS—backed by ~80% China PKP balloon share and supply ties to Stryker / Medtronic member companies—the KT-00-05 is built for tertiary hospitals, spine ASCs, and interventional radiology suites that need a reproducible, OEM/ODM-customizable 11G PKP tray rather than à-la-carte instruments.

Kyphoplasty