Cleared Traditional

K130146 - SYNTHES SYNFLATE VERTEVRAL BALLOON SYSTEM

K130146 is an FDA 510(k) clearance for SYNTHES SYNFLATE VERTEVRAL BALLOON SYSTEM, manufactured by Synthes (Usa), LLC. The device is a Class 2 Orthopedic device with product code NDN cleared through the Traditional 510(k) pathway after a 118-day FDA review.

K130146 · Synthes (Usa), LLC · Orthopedic device
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May 2013
Decision
118d
Days
Class 2
Risk

K130146 is an FDA 510(k) clearance for the SYNTHES SYNFLATE VERTEVRAL BALLOON SYSTEM. Classified as Cement, Bone, Vertebroplasty (product code NDN), Class II - Special Controls.

Submitted by Synthes (Usa), LLC (West Chester, US). The FDA issued a Cleared decision on May 20, 2013 after a review of 118 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 Synthes (Usa), LLC devices

FDA 510(k) Submission Details - K130146

510(k) Number K130146 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 2013
Decision Date May 20, 2013
Days to Decision 118 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 faster than avg
Panel avg: 122d · This submission: 118d
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 92
Devices cleared under the same product code (NDN) and FDA review panel - the closest regulatory comparables to K130146.
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