# K082615: Grafton R II Edbm, Demineralized Bone Matrix Allograft, Resorbable Calcium Salt Bone Void Filler Devices

- Pathway: 510(k) (Traditional)
- Applicant: Osteotech, Inc.
- Decided: Oct 16, 2008 after 37 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.
7 later devices descend from it; 3 cite it directly.
0 of 8 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
- K123691: Magnifuse Bone Graft (Cleared as Grafton II Edbm) (2013), 5 descendants of its own
- K122513: Cleared Under Grafton II Edbm (2013), 4 descendants of its own
- K172130: Resorbable Mesh Device (2017), 2 descendants of its own
- K203218: CaP Spheres Pellet Pack (2021), 0 descendants of its own
- K200290: Resorbable Mesh Pouch (Ballast MT, OsteoBallast MT) (2020), 0 descendants of its own

## Recalls of this device
- Jul 31, 2023 · Class II · Z-2524-2023: The incorrect product labeling was applied to the product indicating the wrong size of product.

## Indications for use
GRAFTON®II eDBM is intended for use as a bone graft substitute, and bone void filler in bony voids or gaps of the skeletal system (i.e., spine, pelvis and extremities) not intrinsic to the stability of the bony structure. The voids or gaps may be surgically created defects or defects created by traumatic injury to the bone. GRAFTON®II eDBM is resorbed/remodeled and is replaced by host bone during the healing process.

Source page: https://510kreport.com/device/K082615
Methodology: https://510kreport.com/methodology