# K102397: Kyphon Xpede Bone Cement

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic
- Decided: Feb 28, 2011 after 188 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 K002652 (2001). 7 ancestors in all.
165 later devices descend from it; 4 cite it directly.
0 of 173 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093828: Kyph X HV-R Bone Cement, Medtronic, Inc. (2010). Our OCR of the scanned summary read K093829, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “KyphX HV-R® Bone Cement”.
- K041584: Kyphx HV-R Bone Cement, Model C01A, Kyphon, Inc. (2004) Summary page 1.
- K033801: Kyphx HV-R, Model C01A, Kyphon, Inc. (2004) Summary page 1.
- K060300: Confidence High Viscosity Bone Cement, Disc-O-Tech Medical Technologies, Ltd. (2006) Summary page 1.

## Most influential descendants
- K150460: KYPHON (R) HV-R (R) Bone Cement (2015), 162 descendants of its own
- K152604: KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw Set (2016), 159 descendants of its own
- K160879: CONFIDENCE™ High Viscosity Spinal Cement, VIPER® and EXPEDIUM® Fenestrated Screw Systems (2016), 106 descendants of its own
- K170347: CD HORIZON™ Fenestrated Screw Set (2017), 91 descendants of its own
- K171938: KYPHON Xpede Bone Cement, CD HORIZON Fenestrated Screw Set (2017), 64 descendants of its own

## Indications for use
Kyphon® Xpede™ Bone Cement is indicated for the treatment of pathological fractures of the vertebral body due to osteoporosis, cancer, or benign lesions using a kyphoplasty or vertebroplasty procedure. Cancer includes multiple myeloma and metastatic lesions, including those arising from breast or lung cancer, or lymphoma. Benign lesions include hemangioma and giant cell tumor.

Source page: https://510kreport.com/device/K102397
Methodology: https://510kreport.com/methodology