# K190814: AccuFill Bone Substitute Material

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer Knee Creations
- Decided: Jun 10, 2019 after 73 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: 11 generations back to K960978 (1996). 40 ancestors in all.
No later device cites it as a predicate yet.
0 of 41 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062630: Ossipro Bone Substitute Material, Etex Corp. (2007) Summary page 5.
- K093447: Carrigen, Etex Corp. (2010) Summary page 5.
- K101557: Gamma-BSM, Beta-BSM, Equivabone, Carigen, Etex Corp. (2010) Summary page 5.
- K182107: CarriGen PF, Etex Corporation (2018) Summary page 5.

## Indications for use
AccuFill Bone Substitute Material is an injectable, self-setting, macroporous, osteoconductive, calcium phosphate bone graft substitute material that is intended for use to fill bony voids or gaps of the skeletal system of the extremities, spine (i.e., posterolateral spine), and the pelvis that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. AccuFill BSM is a bone graft substitute that resorbs and is replaced with new bone during the healing process.

Source page: https://510kreport.com/device/K190814
Methodology: https://510kreport.com/methodology