# K143533: Fibergraft BG Putty Bone Graft Substitute

- Pathway: 510(k) (Traditional)
- Applicant: Prosidyan, Inc.
- Decided: Mar 25, 2015 after 103 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: 10 generations back to K960978 (1996). 27 ancestors in all.
31 later devices descend from it; 1 cites it directly.
0 of 59 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141956: Fibergraft BG Morsels, Prosidyan, Inc. (2014) Summary page 4.
- K132805: BG Morsels, Prosidyan, Inc. (2014) Summary page 4.
- K060728: Novabone Putty - Bioactive Synthetic Graft, Novabone Products, LLC (2006) Summary page 4.
- K080009: Novabone Putty- Bioactive Synthetic Graft, Novabone Products, LLC (2008) Summary page 4.
- K101860: Novabone Putty- Bioactive Synthetic Bone Graft, Novabone Products, LLC (2010) Summary page 4.
- K110368: Novabone Putty - Bioactive Synthetic Bone Graft, Novabone Products, LLC (2011) Summary page 4.
- K112773: Novabne Putty Bioactive Synthetic Bone Graft, Novabone Products, LLC (2011) Summary page 4.

## Most influential descendants
- K170306: FIBERGRAFT BG Putty Bone Graft Substitute (2017), 30 descendants of its own
- K222276: CONDUIT Cages; FIBERGRAFT BG Putty (2022), 29 descendants of its own
- K223731: NuVasive Modulus-C Interbody System (2023), 11 descendants of its own
- K231735: NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody System; NuVasive CoRoent Small Interlock System; NuVasive CoRoent Small Interlock II System; NuVasive CoRoent Small Ti-C System; NuVasive Cohere Cervical Interbody System (2023), 9 descendants of its own
- K231076: VariLift®-C Interbody Fusion System (2023), 4 descendants of its own

## Indications for use
FIBERGRAFT™ BG Putty - Bone Graft Substitute is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. FIBERGRAFT™ BG Putty is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities and pelvis). 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 Putty is not indicated for use in load-bearing applications; therefore, standard internal or external stabilization techniques must be followed to obtain rigid stabilization.

Source page: https://510kreport.com/device/K143533
Methodology: https://510kreport.com/methodology