# K080873: Opacity + Bone Cement

- Pathway: 510(k) (Special)
- Applicant: Teknimed, S.A.
- Decided: Aug 28, 2008 after 150 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: 4 generations back to K002652 (2001). 6 ancestors in all.
20 later devices descend from it; 2 cite it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043593: Spine-Fix Biomimetic Bone Cement, Teknimed, S.A. (2006) Summary page 1.

## Most influential descendants
- K103433: F20 (2011), 18 descendants of its own
- K221926: Invictus® Bone Cement, Invictus Spinal Fixation System (2022), 14 descendants of its own
- K232275: Invictus® Spinal Fixation System (2023), 11 descendants of its own
- K242364: IdentiTi™ II Interbody System (2024), 4 descendants of its own
- K232044: Invictus Robotic Navigation Instruments (2023), 3 descendants of its own

## Indications for use
The Opacity + Bone Cement is used for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures of the vertebral body may result from osteoporosis, benign lesions (hemangioma), or malignant lesions (metastatic cancers, myeloma).

Source page: https://510kreport.com/device/K080873
Methodology: https://510kreport.com/methodology