Cleared Traditional

K141419 - ZVPLASTY

K141419 is an FDA 510(k) clearance for ZVPLASTY, manufactured by Zavation, LLC. The device is a Class 2 Orthopedic device with product code NDN cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K141419 · Zavation, LLC · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2014
Decision
106d
Days
Class 2
Risk

K141419 is an FDA 510(k) clearance for the ZVPLASTY. Classified as Cement, Bone, Vertebroplasty (product code NDN), Class II - Special Controls.

Submitted by Zavation, LLC (Flowood, US). The FDA issued a Cleared decision on September 12, 2014 after a review of 106 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3027 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K141419

510(k) Number K141419 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 29, 2014
Decision Date September 12, 2014
Days to Decision 106 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
16d faster than avg
Panel avg: 122d · This submission: 106d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NDN Device Classification - Class 2, Special Controls

Product Code NDN Cement, Bone, Vertebroplasty
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3027
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 - NDN Cement, Bone, Vertebroplasty

All 107
Devices cleared under the same product code (NDN) and FDA review panel - the closest regulatory comparables to K141419.
Osseoflex SB Straight Balloon, 10g/4ml, Osseoflex SB Straight Balloon, 10g/2ml
K150607 · Osseon, LLC · Apr 2015
InterV Kyphoplasty Catheter (Balloon Length: 10,15 and 20mm) InterV Kyphoplasty Catheter (Mini) (Balloon Length: 10, 15 and 20mm)
K150322 · Pan Medical , Ltd. · Mar 2015
GUARDIAN-SG Inflatable Bone Expander System
K143006 · Bm Korea Co., Ltd. · Jan 2015
OSSEOFLEX SB, 10G/4ML, OSSEOFLEX SB, 10G/2ML
K141930 · Osseon, LLC · Aug 2014
KIVA VCF TREATMENT SYSTEM
K141141 · Benvenue Medical, Inc. · Aug 2014
OSSEOFLEX SB
K140937 · Osseon, LLC · Jun 2014