# K113742: KMC Kyphoplasty System

- Pathway: 510(k) (Traditional)
- Applicant: Shanghai Kinetic Medical Co., Ltd.
- Decided: Sep 17, 2012 after 272 days
- Product code: NDN (Cement, Bone, Vertebroplasty)
- Device class: 2
- Regulation: 21 CFR 888.3027
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K953522 (1996). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103231: Kyphon Inflation Syringe, Medtronic Spine, LLC (2011) Summary page 1.

## Cited in the summary but kept off the family tree
- K061222: Injectra Injection Needle, Medi-Globe Corp. (2006). Our reading of the summary gave K061222, FDA’s number for Injectra Injection Needle (Medi-Globe Corp.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Kyphx Inflatable Bone Tamp”. Kept off the family tree. Summary page 1.

## Indications for use
The KMC Kyphoplasty System is intended to be used for the reduction and fixation of fractures and/or creation of a void in cancellous bone in the spine. This includes use during percutaneous vertebral augmentation. The system is to be used with cleared spinal polymethylmethacrylate (PMMA) bone cements indicated for use during percutaneous vertebral augmentation, such as kyphoplasty.

Source page: https://510kreport.com/device/K113742
Methodology: https://510kreport.com/methodology