# K212135: Dry DBM- A Putty

- Pathway: 510(k) (Traditional)
- Applicant: Seaspine Corporation
- Decided: Oct 4, 2021 after 88 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: 4 generations back to K040980 (2004). 9 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091193: Accell EVO3C, Isotis Orthobiologics, Inc. (2009) Summary page 4.

## Most influential descendants
- K231030: Cove Putty, OsteoCove Putty (2023), 0 descendants of its own

## Indications for use
Dry DBM-A Putty 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

Source page: https://510kreport.com/device/K212135
Methodology: https://510kreport.com/methodology