# K172130: Resorbable Mesh Device

- Pathway: 510(k) (Traditional)
- Applicant: SeaSpine Orthopedics Corporation
- Decided: Nov 16, 2017 after 125 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
Longest line of descent: 2 generations back to K051195 (2005). 4 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123691: Magnifuse Bone Graft (Cleared as Grafton II Edbm), Medtronic Sofamor Danek, Inc. (2013) Summary page 4.
- K082615: Grafton R II Edbm, Demineralized Bone Matrix Allograft, Resorbable Calcium Salt Bone Void Filler Devices, Osteotech, Inc. (2008) Summary page 4.
- K122513: Cleared Under Grafton II Edbm, Medtronic Sofamor Danek, Inc. (2013) Summary page 4.

## Most influential descendants
- K200290: Resorbable Mesh Pouch (Ballast MT, OsteoBallast MT) (2020), 0 descendants of its own
- K193040: Resorbable Mesh Device (2019), 0 descendants of its own

## Recalls of this device
- Jul 2, 2026 · Class II · Z-2820-2026: Demineralized bone matrix (DBM) in resorbable mesh indicated for use with autograft as a bone graft extender in the posterolateral spine and pelvis, were filled with approx. 4.5 cc DBM (fill for 45 11

## Indications for use
The Resorbable Mesh Device is intended to fill voids and gaps in the skeletal system that are not intrinsic to the stability of the bony structure. The product is indicated for use with autograft as a bone graft extender in the posterolateral spine and pelvis. The voids or gaps may be surgically created defects or the result of traumatic injury to the bone. The Resorbable Mesh Device is resorbed/remodeled and replaced by host bone during the healing process.

Source page: https://510kreport.com/device/K172130
Methodology: https://510kreport.com/methodology