KMC Kyphoplasty System
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K113742 FDA 510(k)
- FDA Product Code
- NDN FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3027 FDA 510(k)
- Regulation Number
- 888.3027 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The KMC Kyphoplasty System is a Cement, Bone, Vertebroplasty device, classified under FDA’s Class II regulatory category. It is designed for the reduction and fixation of vertebral fractures, including the creation of a void in cancellous bone within the spine, typically used in percutaneous vertebral augmentation procedures. The system stabilizes compressed vertebrae by deploying bone cement to restore structural integrity and alignment.
The system is supplied as a sterile, single-use orthopedic toolset for surgical use in spinal procedures. It includes components for balloon kyphoplasty, bone cement injection, and fixation, with sizes and configurations tailored for vertebral body augmentation. Compliance with FDA 510(k) clearance and MDR ensures adherence to orthopedic surgical standards. Storage requires adherence to manufacturer guidelines for sterile packaging integrity, and its use is restricted to qualified surgical environments.
Frequently asked questions
What types of vertebral fractures is the KMC Kyphoplasty System designed to treat and how does it work?
The KMC Kyphoplasty System is specifically designed for the reduction and fixation of vertebral fractures, including those caused by osteoporosis or trauma. It works by creating a void within the cancellous bone of the affected vertebra using a balloon kyphoplasty technique. Once the void is formed, bone cement is injected to stabilize the vertebra, restoring its structural integrity and alignment. This process helps alleviate pain, prevent further collapse, and improve spinal stability.
Is the KMC Kyphoplasty System intended for single-use or can it be reused?
The KMC Kyphoplasty System is explicitly supplied as a sterile, single-use orthopedic toolset. Reuse is not recommended or supported by the manufacturer, as it could compromise sterility and patient safety. Each component is designed for one surgical procedure only.
What storage requirements must be followed to maintain the sterility of the KMC Kyphoplasty System?
The system must be stored according to the manufacturer’s guidelines to preserve the integrity of its sterile packaging. This includes keeping it in a clean, dry environment, away from direct sunlight or extreme temperatures, and ensuring the packaging remains unopened and undamaged until use. Proper storage is critical to maintaining sterility and preventing contamination before surgery.
What regulatory pathways has the KMC Kyphoplasty System followed, and what does that mean for its use?
The KMC Kyphoplasty System has undergone FDA 510(k) clearance and MDR (Medical Device Regulation) compliance, confirming it meets orthopedic surgical standards. This means the device has been evaluated for safety and effectiveness by regulatory authorities, ensuring it adheres to stringent quality and performance criteria before clinical use. Its classification under FDA’s Class II category also indicates it is subject to additional manufacturing and labeling controls.
Are there different sizes or models available for the KMC Kyphoplasty System, and how does that affect procedure planning?
Yes, the system includes sizes and configurations tailored for vertebral body augmentation, allowing for customization based on the patient’s anatomy and fracture characteristics. The specific sizing ensures proper fit and effectiveness during balloon kyphoplasty and cement injection. Clinicians should consult the manufacturer’s documentation to select the appropriate components for each case, as this impacts procedural success and patient outcomes.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: PDF -K3742. PA6EOF 3 - Food and Drug Administration, Shanghai Kinetic Co., Ltd., Shanghai Kinetic Medical Co., Ltd. FG0005-15 KMC Kyphoplasty System
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K113742 | Class II | Active |
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Manufacturer
- Manufacturer
- Shanghai Kinetic Medical Co., Ltd.
Sources (2)
- FDA 510(k) K113742 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 19, 2026