# K120354: Beta-TCP Granules

- Pathway: 510(k) (Traditional)
- Applicant: Skeletal Kinetics, LLC
- Decided: Mar 21, 2013 after 409 days
- Product code: MQV (Filler, Bone Void, Calcium Compound)
- Device class: 2
- Regulation: 21 CFR 888.3045
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K040216 (2004). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040216: Cerasorb M Ortho, Curasan AG (2004) Summary page 1.

## Indications for use
Beta TCP Granules Bone Void Filler (BVF) is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e., extremities and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Beta TCP Granules is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. Beta TCP Granules BVF will resorb and be replaced with bone during the healing process.

Source page: https://510kreport.com/device/K120354
Methodology: https://510kreport.com/methodology