# K112907: Confidence High Viscosity Spinal Cement, 16G / 20G

- Pathway: 510(k) (Traditional)
- Applicant: Medos International SARL
- Decided: Dec 22, 2011 after 80 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). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060300: Confidence High Viscosity Bone Cement, Disc-O-Tech Medical Technologies, Ltd. (2006) Summary page 1.
- K071927: Modification to Vertebroplastic Radiopaque Bone Cement, Depuy Spine, A Johnson & Johnson Company (2007) Summary page 1.

## Indications for use
CONFIDENCE High Viscosity Spinal Cement is indicated for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures may result from osteoporosis, benign lesions (baemangioma), or malignant lesions (metastatic cancers, myeloma).

Source page: https://510kreport.com/device/K112907
Methodology: https://510kreport.com/methodology