# K132620: Inter V Kyphoplasty Catheter (Balloon Length: 0 MM), Interv Kyphoplasty Catheter (Balloon Lenght: 15 MM), Interv Kyphopl

- Pathway: 510(k) (Traditional)
- Applicant: Pan Medical, Ltd.
- Decided: Apr 16, 2014 after 238 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: 3 generations back to K981251 (1998). 4 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981251: Kyphon Inflatable Bone Tamp, Kyphon, Inc. (1998) Summary page 1.
- K041454: Kyphx Xpander Inflatable Bone Tamps Model#KO8A,KO9A,K13A, Kyphon, Inc. (2004) Summary page 1.

## Most influential descendants
- K150322: InterV Kyphoplasty Catheter (Balloon Length: 10,15 and 20mm) InterV Kyphoplasty Catheter (Mini) (Balloon Length: 10, 15 and 20mm) (2015), 4 descendants of its own
- K162453: 13G InterV Kyphoplasty Catheter (Micro) and 11G InterV Kyphoplasty Catheter (Mini-Flex) (2016), 1 descendant of its own
- K231340: Renova Spine Balloon Catheter (2023), 0 descendants of its own
- K211797: TRACKER Plus Kyphoplasty System (2021), 0 descendants of its own
- K172871: SpineKure Kyphoplasty System (2018), 0 descendants of its own

## Indications for use
InterV Kyphoplasty Catheter is intended to be used for reduction and fixation of fractures and/or creation of a void in cancellous bone in the spine during balloon kyphoplasty (for use with cleared spinal polymethymethacrylate (PMMA) bone cements).

Source page: https://510kreport.com/device/K132620
Methodology: https://510kreport.com/methodology