# K220131: KYPHON VuE Bone Cement

- Pathway: 510(k) (Traditional)
- Applicant: Tecres S.P.A.
- Decided: Apr 18, 2022 after 90 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: 19 generations back to K040583 (2004). 175 ancestors in all.
No later device cites it as a predicate yet.
0 of 176 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102397: Kyphon Xpede Bone Cement, Medtronic (2011) Summary page 5.
- K151227: KYPHON XPEDE Bone Cement, Medtronic (2015) Summary page 5.
- K163032: Kyphon Xpede Bone Cement, Medtronic, Inc. (2017) Summary page 5.
- K171938: KYPHON Xpede Bone Cement, CD HORIZON Fenestrated Screw Set, Medtronic (2017) Summary page 5.
- K191148: Medtronic HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, CD Horizon™ Fenestrated Screw Set, Medtronic Sofamor Danek USA, Inc. (2019) Summary page 5.
- K032945: Simplex X, Stryker Corp. (2004) Summary page 5.

## Indications for use
The KYPHON™ VuE™ Bone Cement is indicated for the treatment of pathological fractures of the vertebral body due to osteoporosis, cancer, or benign lesions using a cementoplasty (i.e. kyphoplasty or vertebroplasty) procedure. It is also indicated for the fixation of pathological fractures of the sacral vertebral body or ala using sacral vertebroplasty or sacroplasty. 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. Pathological fracture may include a symptomatic microfracture (as documented by appropriate imaging and/or presence of a lytic lesion) without obvious loss of vertebral body height.

Source page: https://510kreport.com/device/K220131
Methodology: https://510kreport.com/methodology