# K082793: Intergro DBM

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Spine
- Decided: Apr 2, 2009 after 191 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; 2 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) DynaGraft II: named in the summary without a submission number
- (no number) DBX: named in the summary without a submission number
- (no number) InterGro DBM: named in the summary without a submission number

## Most influential descendants
- K140844: Biosphere Bioactive Bone Graft Putty, 2.5CC, 5CC, 10CC (2014), 1 descendant of its own
- K243609: EquivaBone Osteoinductive Bone Graft Substitute (EquivaBone ) (2024), 0 descendants of its own
- K173301: BioSphere MIS Putty (BioSphere MIS) (2018), 0 descendants of its own

## Indications for use
InterGro DBM products (Putty, Paste, Plus) 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, and as an autograft extender in the spine. InterGro Plus may also be used as a bone void filler in the spine (posterolateral spine). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to bone. InterGro DBM may also be used for filling craniofacial defects and craniotomies that are no larger than 25cm2. 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/K082793
Methodology: https://510kreport.com/methodology