# K190283: PROSTIM Injectable Inductive Graft

- Pathway: 510(k) (Special)
- Applicant: Wrightmedicaltechnologyinc
- Decided: Mar 14, 2019 after 31 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 K013966 (2002). 33 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083270: WMT Composite DBM, Wrightmedicaltechnologyinc (2009) Summary page 4.
- K181255: PRODENSE Bone Graft Substitute, Wrightmedicaltechnologyinc (2018) Summary page 4.

## Most influential descendants
- K200507: PRO-DENSE LoVisc Bone Graft Substitute (2020), 1 descendant of its own
- K213342: PRO-DENSE LoVisc Bone Graft Substitute (2022), 0 descendants of its own

## Indications for use
PRO-67,0™ resultant paste 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 surgically created osseous defects or osseous defects created from traumatic injury to the bone. The paste provides a bone graft substitute that resorbs and is replaced with bone during the healing process. The PRO-67,0™ paste 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-67,0™ is provided sterile for single use only. For the PRO-67,0™ Core Decompression Procedure Kit: The PRO-67,0™ Core Decompression Procedure Kit, consisting of a bone void filler and manual surgical instruments, is intended to be used during core decompression procedures. The bone void filler component resorbs and is replaced with bone during the healing process. The bone void filler included in the PRO-67,0™ Core Decompression Procedure Kit is not intended to be used as a load-bearing device.

Source page: https://510kreport.com/device/K190283
Methodology: https://510kreport.com/methodology