Cleared Traditional

K133669 - MEDINAUT KYPHOPLASTY SYSTEM

K133669 is an FDA 510(k) clearance for MEDINAUT KYPHOPLASTY SYSTEM, manufactured by Imedicom. The device is a Class 2 Orthopedic device with product code NDN cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K133669 · Imedicom · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2014
Decision
126d
Days
Class 2
Risk

K133669 is an FDA 510(k) clearance for the MEDINAUT KYPHOPLASTY SYSTEM. Classified as Cement, Bone, Vertebroplasty (product code NDN), Class II - Special Controls.

Submitted by Imedicom (Fullerton, US). The FDA issued a Cleared decision on April 4, 2014 after a review of 126 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 - K133669

510(k) Number K133669 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 29, 2013
Decision Date April 04, 2014
Days to Decision 126 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
4d slower than avg
Panel avg: 122d · This submission: 126d
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 K133669.
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CROSSTREES PVA POD
K133372 · Crosstrees Medical, Inc. · Dec 2013
CROSSTREES PVA POD
K130089 · Crosstrees Medical, Inc. · Aug 2013