# K200507: PRO-DENSE LoVisc Bone Graft Substitute

- Pathway: 510(k) (Traditional)
- Applicant: Wrightmedicaltechnologyinc
- Decided: Oct 21, 2020 after 233 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: 12 generations back to K013966 (2002). 35 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181255: PRODENSE Bone Graft Substitute, Wrightmedicaltechnologyinc (2018) Summary page 4.
- K182823: PRODENSE Bone Graft Substitute, Wrightmedicaltechnologyinc (2018) Summary page 4.
- K190283: PROSTIM Injectable Inductive Graft, Wrightmedicaltechnologyinc (2019) Summary page 4.

## Most influential descendants
- K213342: PRO-DENSE LoVisc Bone Graft Substitute (2022), 0 descendants of its own

## Indications for use
PRO-DENSE™ LoVisc Bone Graft Substitute is intended for use as a bone graft substitute to be injected or digitally packed into open bone voids/gaps that are not intrinsic to the stability of bony structure of the skeletal system (i.e., the extremities and pelvis) to cure in situ. These open bone voids may be the result of benign bone cysts and tumors (in adults and pediatric patients ≥ 6 years old), surgically created osseous defects or osseous defects created from traumatic injury to the bone. PRO-DENSE™ LoVisc Bone Graft Substitute resorbs and is replaced with bone during the healing process. PRO-DENSE™ LoVisc Bone Graft Substitute cured in situ provides an open void/gap filler that can augment provisional hardware (e.g. K Wires) to help support bone fragments during the surgical procedure. The cured paste acts only as a temporary support media and is not intended to provide structural support during the healing process. PRO-DENSE™ LoVisc Bone Graft Substitute is provided sterile for single use only.

Source page: https://510kreport.com/device/K200507
Methodology: https://510kreport.com/methodology