# K242799: PliaFX Flo

- Pathway: 510(k) (Traditional)
- Applicant: Lifenet Health
- Decided: Nov 21, 2024 after 65 days
- Product code: MBP (Filler, Bone Void, Osteoinduction (W/O Human Growth Factor))
- 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: 3 generations back to K963562 (1997). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053098: Optium DBM Gel and Putty, Lifenet (2005) Summary page 5.

## Indications for use
PliaFX® Flo is indicated for bony voids or gaps that are not intrinsic to the stability of the bony structure. It is indicated to be placed into the bony voids or gaps of the skeletal system (e.g., the extremities, spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. This product provides a bone void filler that remodels into the recipient’s skeletal system.

Source page: https://510kreport.com/device/K242799
Methodology: https://510kreport.com/methodology