# K150064: Synthetic Bone Graft (TriPore HA, TriPore BP90, TriPore BP15)

- Pathway: 510(k) (Traditional)
- Applicant: Orthogem, Ltd.
- Decided: Sep 4, 2015 after 234 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: 6 generations back to K013966 (2002). 18 ancestors in all.
No later device cites it as a predicate yet.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070132: Tripore, Models HA, BP90, BP15, Orthogem Limited (2007) Summary page 4.
- K110787: Tripore TDD (HA), Tripore TDD (BP90), Tripore TDD (BP15), Orthogem Limited (2011) Summary page 4.

## Indications for use
TriPore HA, TriPore BP90, TriPore BP15, is a synthetic bone graft intended to be packed into bone defects of the skeletal system (extremities, posterolateral spine, or pelvis) which are not intrinsic to the stability of the bony structure. These defects may be surgically created voids or from traumatic injury to the bone. The device gradually resorbs and is replaced with bone during the healing process. Rigid fixation techniques should be used in conjunction with this device.

Source page: https://510kreport.com/device/K150064
Methodology: https://510kreport.com/methodology