Cleared Traditional

K132817 - KIVA VCF TREATMENT SYSTEM

K132817 is an FDA 510(k) clearance for KIVA VCF TREATMENT SYSTEM, manufactured by Benvenue Medical, Inc.. The device is a Class 2 Orthopedic device with product code NDN cleared through the Traditional 510(k) pathway after a 137-day FDA review.

K132817 · Benvenue Medical, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2014
Decision
137d
Days
Class 2
Risk

K132817 is an FDA 510(k) clearance for the KIVA VCF TREATMENT SYSTEM. Classified as Cement, Bone, Vertebroplasty (product code NDN), Class II - Special Controls.

Submitted by Benvenue Medical, Inc. (Hillsborough, US). The FDA issued a Cleared decision on January 24, 2014 after a review of 137 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.

View all Benvenue Medical, Inc. devices

FDA 510(k) Submission Details - K132817

510(k) Number K132817 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 2013
Decision Date January 24, 2014
Days to Decision 137 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
15d slower than avg
Panel avg: 122d · This submission: 137d
Pathway characteristics
Predicate-based equivalence.

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Orthopedic devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT01123512 Completed Interventional Industry-sponsored

The Kiva® System as a Vertebral Augmentation Treatment

The Kiva® System as a Vertebral Augmentation Treatment - A Safety and Effectiveness Trial

300
Patients (actual)
21
Sites
Treatment
Purpose
Single blind
Masking
Condition studied Spinal Fractures; Fractures, Compression; Back Injuries
Study design Parallel
Eligibility All sexes · 50 Years+
Principal investigator Steven R. Garfin, MD
Sponsor Benvenue Medical, Inc. (industry)
Started 2010-07-01 → Primary completion 2013-05-01
Primary outcome
Proportion of Participants With Study Success
View full study on ClinicalTrials.gov

Regulatory Peers - NDN Cement, Bone, Vertebroplasty

All 92
Devices cleared under the same product code (NDN) and FDA review panel - the closest regulatory comparables to K132817.
OSSEOFLEX SB
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K132620 · Pan Medical , Ltd. · Apr 2014
MEDINAUT KYPHOPLASTY SYSTEM
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CROSSTREES PVA POD
K133372 · Crosstrees Medical, Inc. · Dec 2013
CROSSTREES PVA POD
K130089 · Crosstrees Medical, Inc. · Aug 2013
PARALLAX BALLOON INFLATABLE BONE TAMP-10 MM BALLOON PARALLAX BALLOON INFLATABLE BONE TAMP-15 MM BALLOON PARALLAX BALLOON
K122503 · Neuro Therm, Inc. · Jun 2013