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PliaFX Flo

FDA 510(k)

Class II (US FDA 510(k))

510(k) K242799

by Lifenet Health

Identifiers

510(k) Number
K242799 FDA 510(k)
FDA Product Code
MBP FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 888.3045 FDA 510(k)
Regulation Number
888.3045 FDA 510(k)
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

PliaFX Flo is a demineralized bone matrix (DBM) comprised of optimally demineralized 1-3 fibers with surface characteristics that set the standard for osseointegration, combined with a glycerol carrier. It is classified as a Filler, Bone Void, Osteoinduction (W/O Human Growth Factor) device under FDA regulation number 888.3045.

PliaFX Flo is supplied in a pre-filled syringe format for precise delivery with no intraoperative preparation required. It is a Class II device cleared via the FDA 510(k) process under K number K242799, manufactured by LifeNet Health in Virginia Beach, VA.

Frequently asked questions

What is PliaFX Flo used for?

PliaFX Flo is a demineralized bone matrix (DBM) filler designed for bone void filling and osteoinduction without human growth factors, intended to support bone regeneration in orthopedic applications.

How is PliaFX Flo supplied and prepared for use?

PliaFX Flo is supplied in a pre-filled syringe format, enabling precise delivery with no intraoperative preparation required, which streamlines surgical workflow and reduces handling steps.

Is PliaFX Flo sterile and intended for single use?

Yes, PliaFX Flo is provided sterile in its pre-filled syringe and is intended for single-use only to maintain sterility and prevent cross-contamination during surgical procedures.

What regulatory pathway was used for PliaFX Flo?

PliaFX Flo was cleared via the FDA 510(k) process under K number K242799, demonstrating substantial equivalence to a predicate device for its intended use as a bone void filler.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: PliaFX® Flo | LifeNet Health, PDF LifeNet Health Unveils Revolutionary PliaFX® Flo: The Future of Bone ..., LifeNet Health Launches PliaFX Flo DBM | ORTHOWORLD

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Lifenet Health

Sources (1)

  • FDA 510(k) K242799 24 fields · synced Oct 1, 2026