# K070132: Tripore, Models HA, BP90, BP15

- Pathway: 510(k) (Traditional)
- Applicant: Orthogem Limited
- Decided: Jul 13, 2007 after 178 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
No predicates in its family tree.
3 later devices descend from it; 3 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Orthovita Vitoss: named in the summary without a submission number

## Most influential descendants
- K110787: Tripore TDD (HA), Tripore TDD (BP90), Tripore TDD (BP15) (2011), 1 descendant of its own
- K202639: si-Mochi (2021), 0 descendants of its own
- K150064: Synthetic Bone Graft (TriPore HA, TriPore BP90, TriPore BP15) (2015), 0 descendants of its own

## Indications for use
TriPore HA, TriPore BP90 and TriPore BP15 is intended to be packed into bone defects of the skeletal system (extremities, 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. This device can also be used for maxillofacial surgery for the reconstruction of the facial skeleton. 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/K070132
Methodology: https://510kreport.com/methodology