# K103433: F20

- Pathway: 510(k) (Special)
- Applicant: Teknimed, S.A.
- Decided: Jan 3, 2011 after 40 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). 8 ancestors in all.
18 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)
- K090435: Vertecem, Teknimed, S.A. (2009) Summary page 1.
- K080873: Opacity + Bone Cement, Teknimed, S.A. (2008) Summary page 1.
- K043593: Spine-Fix Biomimetic Bone Cement, Teknimed, S.A. (2006). Our reading of the summary gave K045593, which is not a number in FDA’s lists. Corrected to the only number one digit away that is an earlier device of this one’s maker, Teknimed, S.A., in this field.

## Most influential descendants
- 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
- K241519: Invictus® Small Stature Spinal Fixation System (2024), 2 descendants of its own

## Indications for use
The F20 is indicated 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/K103433
Methodology: https://510kreport.com/methodology