# K031399: Intergro DBM

- Pathway: 510(k) (Traditional)
- Applicant: Interpore Cross Intl.
- Decided: Feb 18, 2005 after 655 days
- Product code: MQV (Filler, Bone Void, Calcium Compound)
- Device class: 2
- Regulation: 21 CFR 888.3045
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
69 later devices descend from it; 6 cite it directly.
0 of 70 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 no predicate by number.

## Most influential descendants
- K063050: Cap Plus (2007), 34 descendants of its own
- K080329: Cap Plus, Equivabone, Cap/DBM (2008), 29 descendants of its own
- K090310: Equivabone (2009), 28 descendants of its own
- K040419: Dynagraft II (2005), 28 descendants of its own
- K090855: Equivabone Osteoinductive Bone Graft Substitute (2009), 25 descendants of its own

## Recalls of this device
- Oct 15, 2007 · Not classified · Z-0618-2008: Unapproved Testing:Interpore Cross International was recently informed that one of its human tissue suppliers, LifeLink Tissue Bank ("LifeLink"), utilized unapproved diagnostic testing (HBsAg & HBc) o

## Indications for use
InterGro DBM products are to be used for filling bony voids or gaps in the extremities, and pelvis that are not intrinsic to the bony stability of the structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to bone. The device may also be used for filling craniofacial defects and craniotomies that are no larger than 25cm 2. The amount of InterGro DBM products to be used should be based on the type of procedure and size of the graft site.

Source page: https://510kreport.com/device/K031399
Methodology: https://510kreport.com/methodology