Cleared Traditional

K110604 - VBB SYSTEM (FDA 510(k) Clearance)

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K110604 · Synthes · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2011
Decision
285d
Days
Class 2
Risk

K110604 is an FDA 510(k) clearance for the VBB SYSTEM. Classified as Cement, Bone, Vertebroplasty (product code NDN), Class II - Special Controls.

Submitted by Synthes (West Chester, US). The FDA issued a Cleared decision on December 13, 2011 after a review of 285 days - an extended review cycle.

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 devices

Submission Details

510(k) Number K110604 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 2011
Decision Date December 13, 2011
Days to Decision 285 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
163d slower than avg
Panel avg: 122d · This submission: 285d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 K110604.
XeliteMed SuperM-Fix Spinal Bone Cement
K251896 · Xelite Biomed , Ltd. · Jan 2026
VCFix Spinal System
K250637 · Amber Implants · May 2025
XeliteMed VertehighFix High Viscosity Spinal Bone Cement System
K243537 · Xelite Biomed , Ltd. · Apr 2025
XeliteMed VertehighFix High Viscosity Spinal Bone Cement
K241775 · Xelite Biomed , Ltd. · Sep 2024
Balloon Inflation System
K232842 · Ningbo Hicren Biotechnology Co., Ltd. · Feb 2024
V-STRUT® Vertebral Implant
K240084 · Hyprevention · Feb 2024