Cleared Traditional

K211514 - Longeviti PorousFit implant

K211514 is an FDA 510(k) clearance for Longeviti PorousFit implant, manufactured by Longeviti Neuro Solutions, LLC. The device is a Class 2 General & Plastic Surgery device with product code KKY cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K211514 · Longeviti Neuro Solutions, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2021
Decision
59d
Days
Class 2
Risk

K211514 is an FDA 510(k) clearance for the Longeviti PorousFit implant. Classified as Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction (product code KKY), Class II - Special Controls.

Submitted by Longeviti Neuro Solutions, LLC (Hunt Valley, US). The FDA issued a Cleared decision on July 15, 2021 after a review of 59 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.3500 - the FDA general and plastic surgery device 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 Longeviti Neuro Solutions, LLC devices

FDA 510(k) Submission Details - K211514

510(k) Number K211514 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 17, 2021
Decision Date July 15, 2021
Days to Decision 59 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 115d · This submission: 59d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KKY Device Classification - Class 2, Special Controls

Product Code KKY Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.3500
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 General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - KKY Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction

Devices cleared under the same product code (KKY) and FDA review panel - the closest regulatory comparables to K211514.
STRYKER PATIENT SPECIFIC POLYMER IMPLANT
K103010 · Howmedica Osteonics Corp., Dba Stryker Orthopaedics · Oct 2010
HTR POLYMER, HTR-MX
K904111 · United States Surgical, A Division of Tyco Healthc · Nov 1990
UHMWPE SURGICAL MESH
K894478 · Biomet, Inc. · Mar 1990
SURG. GOWN & DRAPE, LOW LINT TREATMENT
K781019 · Kimberly-Clark Corp. · Aug 1978