# K110998: Affirm (TM) VCF System

- Pathway: 510(k) (Traditional)
- Applicant: Algea Therapies
- Decided: Oct 25, 2011 after 197 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.
6 later devices descend from it; 2 cite it directly.
0 of 11 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.

## Most influential descendants
- K123942: Stryker Ivas Balloon Catheter (2013), 5 descendants of its own
- K152557: Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon Catheters (2016), 2 descendants of its own
- K172116: Stryker iVAS Elite Inflatable Vertebral Augmentation System (Stryker iVAS Elite Balloon Catheter) (2018), 1 descendant of its own
- K172214: Modified Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon Catheters (2017), 1 descendant of its own
- K200763: Osteo-site Vertebral Balloon (2020), 0 descendants of its own

## Indications for use
The AFFIRM™ VCF System is intended to be used for the reduction and fixation of fractures and/or creation of a void in cancellous bone in the spine, hand, tibia, radius, and calcaneus. This includes percutaneous vertebral augmentation. Vertebral compression fractures may result from osteoporosis, benign lesions and/or malignant lesions such as metastatic cancer and myeloma. The system is to be used with cleared spinal polymethylmethacrylate (PMMA) bone cements indicated for use during percutaneous vertebral augmentation, such as kyphoplasty.

Source page: https://510kreport.com/device/K110998
Methodology: https://510kreport.com/methodology