# K140937: Osseoflex SB

- Pathway: 510(k) (Special)
- Applicant: Osseon, LLC
- Decided: Jun 19, 2014 after 69 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). 10 ancestors in all.
7 later devices descend from it; 1 cites it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122533: Osseoflex SB Inflatable Bone Tamp, Osseon Therapeutics, Inc. (2012) Summary page 1.

## Most influential descendants
- K141930: Osseoflex SB, 10G/4ML, Osseoflex SB, 10G/2ML (2014), 6 descendants of its own
- K150607: Osseoflex SB Straight Balloon, 10g/4ml, Osseoflex SB Straight Balloon, 10g/2ml (2015), 4 descendants of its own
- K192449: Joline Kyphoplasty System Allevo (2020), 3 descendants of its own
- K223709: Kyphoplasty Balloon Catheter (2023), 2 descendants of its own
- K260203: Fule Vertebroplasty Balloon Catheter (2026), 0 descendants of its own

## Indications for use
The Osseoflex® SB 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 for use during percutaneous vertebral augmentation, such as kyphoplasty.

Source page: https://510kreport.com/device/K140937
Methodology: https://510kreport.com/methodology