# K102937: Osteophil Beta-TCP

- Pathway: 510(k) (Traditional)
- Applicant: Cytophil, Inc.
- Decided: Dec 27, 2010 after 84 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: 3 generations back to K990131 (1999). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050357: Camceram TCP, Cam Implants B.V. (2005) Summary page 2.

## Indications for use
Osteophil B-TCP is a resorbable bone void filler intended to fill bony void or gaps of the extremities, posterolateral spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.

Source page: https://510kreport.com/device/K102937
Methodology: https://510kreport.com/methodology