# K172871: SpineKure Kyphoplasty System

- Pathway: 510(k) (Traditional)
- Applicant: Hanchang Co., Ltd.
- Decided: May 29, 2018 after 250 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: 6 generations back to K981251 (1998). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153296: MEDINAUT Kyphoplasty System, Imedicom Co., Ltd. (2016) Summary page 5.
- K150322: InterV Kyphoplasty Catheter (Balloon Length: 10,15 and 20mm) InterV Kyphoplasty Catheter (Mini) (Balloon Length: 10, 15 and 20mm), Pan Medical, Ltd. (2015) Summary page 5.
- K131824: Avaflex Vertebral Balloon System, Care Fusion (2013) Summary page 5.

## Indications for use
The SpineKure 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. This 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/K172871
Methodology: https://510kreport.com/methodology