# K032212: Kyphx Directional Inflatable Bone Tamp, Models K16A and K17A

- Pathway: 510(k) (Traditional)
- Applicant: Kyphon, Inc.
- Decided: Sep 15, 2003 after 56 days
- Product code: HRX (Arthroscope)
- Device class: 2
- Regulation: 21 CFR 888.1100
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K981251 (1998). 1 ancestor in all.
77 later devices descend from it; 4 cite it directly.
0 of 79 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 4.

## Cited in the summary but kept off the family tree
- K102046: KyphX Inflatable Bone Tamp. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 5.

## Most influential descendants
- K041454: Kyphx Xpander Inflatable Bone Tamps Model#KO8A,KO9A,K13A (2004), 73 descendants of its own
- K090211: Inflatable Bone Tamp (2009), 24 descendants of its own
- K093463: Avamax Vertebral Balloon Model VBS1010, VBS1015, VBS1020 (2010), 23 descendants of its own
- K103064: Avamax Vertebral Balloon (2011), 22 descendants of its own
- K034037: Sky Bone Expander System (2004), 15 descendants of its own

## Indications for use
KyphX® Directional Inflatable Bone Tamps are intended to be used as conventional bone tamps for the reduction of fractures and/or creation of a void in cancellous bone in the spine, hand, tibia, radius and calcaneous.

Source page: https://510kreport.com/device/K032212
Methodology: https://510kreport.com/methodology