# K192449: Joline Kyphoplasty System Allevo

- Pathway: 510(k) (Traditional)
- Applicant: Joline GmbH & Co. KG
- Decided: May 27, 2020 after 264 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: 9 generations back to K981251 (1998). 13 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150607: Osseoflex SB Straight Balloon, 10g/4ml, Osseoflex SB Straight Balloon, 10g/2ml, Osseon, LLC (2015) Summary page 4.

## Most influential descendants
- K223709: Kyphoplasty Balloon Catheter (2023), 2 descendants of its own
- K260203: Fule Vertebroplasty Balloon Catheter (2026), 0 descendants of its own
- K252458: Kyphoplasty Balloon Dilatation Catheters (2025), 0 descendants of its own

## Indications for use
The Joline® Kyphoplasty System Allevo is intended to be used for the 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 polymethylmethacrylate (PMMA) bone cements).

Source page: https://510kreport.com/device/K192449
Methodology: https://510kreport.com/methodology