# K041584: Kyphx HV-R Bone Cement, Model C01A

- Pathway: 510(k) (Traditional)
- Applicant: Kyphon, Inc.
- Decided: Jul 7, 2004 after 23 days
- Product code: NDN (Cement, Bone, Vertebroplasty)
- Device class: 2
- Regulation: 21 CFR 888.3027
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K002652 (2001). 3 ancestors in all.
209 later devices descend from it; 10 cite it directly.
0 of 213 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033801: Kyphx HV-R, Model C01A, Kyphon, Inc. (2004) Summary page 1.
- K002652: Surgical Simplex P Radiopaque Bone Cement and Acm and Mixevacii, Stryker Corp. (2001) Summary page 1.
- K032945: Simplex X, Stryker Corp. (2004) Summary page 1.

## Most influential descendants
- K042691: Vertefix Vertebroplasty Procedure Set (2005), 189 descendants of its own
- K060300: Confidence High Viscosity Bone Cement (2006), 176 descendants of its own
- K093828: Kyph X HV-R Bone Cement (2010), 167 descendants of its own
- K102397: Kyphon Xpede Bone Cement (2011), 165 descendants of its own
- K150460: KYPHON (R) HV-R (R) Bone Cement (2015), 162 descendants of its own

## Recalls of this device
- Nov 10, 2009 · Not classified · Z-1625-2011: Product may not reach proper viscosity (dough state) and inconsistency or lack of homogeneity during cement preparation and during delivery period.
- Nov 10, 2009 · Not classified · Z-1624-2011: Product may not reach proper viscosity (dough state) and inconsistency or lack of homogeneity during cement preparation and during delivery period.

## Indications for use
KyphX HV-R bone cement is indicated for the treatment of pathological fractures of the vertebral body due to osteoporosis, cancer, or benign lesions using a balloon kyphoplasty procedure. Cancer includes multiple myeloma and metastatic lesions, including those arising from breast or lung cancer, or lymphoma. Benign lesions include hemagioma and giant cell tumor.

Source page: https://510kreport.com/device/K041584
Methodology: https://510kreport.com/methodology