# K200290: Resorbable Mesh Pouch (Ballast MT, OsteoBallast MT)

- Pathway: 510(k) (Traditional)
- Applicant: SeaSpine Orthopedics Corporation
- Decided: May 11, 2020 after 96 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
Longest line of descent: 3 generations back to K051195 (2005). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172130: Resorbable Mesh Device, SeaSpine Orthopedics Corporation (2017) Summary page 4.

## Indications for use
The Resorbable Mesh Pouch, once filled with autograft, 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 in the posterolateral spine and pelvis as a bone void filler and bone graft extender. The voids or gaps may be surgically created defects or the result of traumatic injury to the bone. Ultimately, the Resorbable Mesh Pouch will be resorbed.

Source page: https://510kreport.com/device/K200290
Methodology: https://510kreport.com/methodology