# K122533: Osseoflex SB Inflatable Bone Tamp

- Pathway: 510(k) (Traditional)
- Applicant: Osseon Therapeutics, Inc.
- Decided: Oct 23, 2012 after 64 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 K981251 (1998). 9 ancestors in all.
8 later devices descend from it; 2 cite 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)
- K041454: Kyphx Xpander Inflatable Bone Tamps Model#KO8A,KO9A,K13A, Kyphon, Inc. (2004) Summary page 1.
- K032212: Kyphx Directional Inflatable Bone Tamp, Models K16A and K17A, Kyphon, Inc. (2003) Summary page 1.
- K010246: Kyphx Inflatable Bone Tamp, Size 20/3,Model K01A, Kyphx Inflatable Bone Tamp, Size 15/3, Model K02A, Kyphon, Inc. (2001) Summary page 1.
- K981251: Kyphon Inflatable Bone Tamp, Kyphon, Inc. (1998) Summary page 1.
- K103064: Avamax Vertebral Balloon, Care Fusion (2011) Summary page 1.
- K093463: Avamax Vertebral Balloon Model VBS1010, VBS1015, VBS1020, Care Fusion (2010) Summary page 1.
- K090211: Inflatable Bone Tamp, Cardinal Health, Inc. (2009) Summary page 1.

## Most influential descendants
- K140937: Osseoflex SB (2014), 7 descendants of its own
- 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

## 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. The system is to be used with cleared spinal polymethyltmethaciylate (PMA4A) bone cements indicated for use during percutaneous vertebral augmentation, such as kyphoplasty.

Source page: https://510kreport.com/device/K122533
Methodology: https://510kreport.com/methodology