# K193040: Resorbable Mesh Device

- Pathway: 510(k) (Special)
- Applicant: SeaSpine Orthopedics Corporation
- Decided: Nov 30, 2019 after 30 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 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/K193040
Methodology: https://510kreport.com/methodology