# K171284: FIBERGRAFT BG Matrix Bone Graft Substitute

- Pathway: 510(k) (Traditional)
- Applicant: Prosidyan, Inc.
- Decided: Jun 30, 2017 after 60 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: 8 generations back to K960978 (1996). 32 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103173: Vitoss BA Bimodal Bioactive Bone Graft Substitute, Orthovita, Inc. (2011) Summary page 4.

## Most influential descendants
- K182670: FIBERGRAFT AERIDYAN Matrix Bone Graft Substitute (2018), 0 descendants of its own

## Indications for use
FIBERGRAFT® BG Matrix - Bone Graft Substitute is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. FIBERGRAFT® BG Matrix is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e., posterolateral spine). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process. FIBERGRAFT® BG Matrix must be used with autogenous bone marrow aspirate and autograft in posterolateral spine.

Source page: https://510kreport.com/device/K171284
Methodology: https://510kreport.com/methodology