Cleared Traditional

K242799 - PliaFX Flo

K242799 is an FDA 510(k) clearance for PliaFX Flo, manufactured by Lifenet Health. The device is a Class 2 Orthopedic device with product code MBP cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K242799 · Lifenet Health · Orthopedic device
Download Printable Device Report (PDF)
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Nov 2024
Decision
65d
Days
Class 2
Risk

K242799 is an FDA 510(k) clearance for the PliaFX Flo. Classified as Filler, Bone Void, Osteoinduction (w/o Human Growth Factor) (product code MBP), Class II - Special Controls.

Submitted by Lifenet Health (Virginia Beach, US). The FDA issued a Cleared decision on November 21, 2024 after a review of 65 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3045 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Lifenet Health devices

FDA 510(k) Submission Details - K242799

510(k) Number K242799 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 2024
Decision Date November 21, 2024
Days to Decision 65 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
57d faster than avg
Panel avg: 122d · This submission: 65d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MBP Device Classification - Class 2, Special Controls

Product Code MBP Filler, Bone Void, Osteoinduction (w/o Human Growth Factor)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3045
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - MBP Filler, Bone Void, Osteoinduction (w/o Human Growth Factor)

All 30
Devices cleared under the same product code (MBP) and FDA review panel - the closest regulatory comparables to K242799.
Vivorte Trabexus EB
K143547 · Vivorte, Inc. · Jan 2015
VIVORTE BVF
K130703 · Vivorte, Inc. · Sep 2013
OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTY
K130498 · Bacterin International, Inc. · May 2013
CLEARED UNDER GRAFTON II EDBM
K122513 · Medtronic Sofamor Danek, Inc. · Mar 2013
SURFUSE GEL AND PUTTY, EXFUSE GEL AND PUTTY
K113728 · Hans Biomed Corp. · Nov 2012
ACCELL EVO3 (FORMERLY ACCELL A2I)
K103742 · Integra Life Sciences · Mar 2011