# K043593: Spine-Fix Biomimetic Bone Cement

- Pathway: 510(k) (Traditional)
- Applicant: Teknimed, S.A.
- Decided: Mar 17, 2006 after 443 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: 3 generations back to K002652 (2001). 5 ancestors in all.
22 later devices descend from it; 4 cite it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041584: Kyphx HV-R Bone Cement, Model C01A, Kyphon, Inc. (2004) Summary page 1.
- K003294: Biomet Lateral Troch Plate, Biomet, Inc. (2000) Summary page 1.

## Most influential descendants
- K080873: Opacity + Bone Cement (2008), 20 descendants of its own
- 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

## Indications for use
Spine Fix cement is used 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 (hemangioma), and malignant lesions (metastatic cancers, myeloma).

Source page: https://510kreport.com/device/K043593
Methodology: https://510kreport.com/methodology