# K103816: Cohesion Bone Cement

- Pathway: 510(k) (Special)
- Applicant: Teknimed Sas
- Decided: Feb 4, 2011 after 37 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.
No later device cites it as a predicate yet.
0 of 9 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 in this product code whose FDA name shares the summary’s words.

## Indications for use
The COHESION Bone Cement 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/K103816
Methodology: https://510kreport.com/methodology