Cleared Traditional

K052170 - SEASPINE VBR SYSTEM

K052170 is the FDA 510(k) clearance for SEASPINE VBR SYSTEM by Seaspine, Inc.. It is a Class 2 Orthopedic device (product code MQP) cleared through the Traditional 510(k) pathway after a 134-day FDA review.

K052170 · Seaspine, Inc. · Orthopedic device
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Dec 2005
Decision
134d
Days
Class 2
Risk

K052170 is an FDA 510(k) clearance for the SEASPINE VBR SYSTEM. Classified as Spinal Vertebral Body Replacement Device (product code MQP), Class II - Special Controls.

Submitted by Seaspine, Inc. (Vista, US). The FDA issued a Cleared decision on December 21, 2005 after a review of 134 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3060 - 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 Seaspine, Inc. devices

Submission Details

510(k) Number K052170 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 2005
Decision Date December 21, 2005
Days to Decision 134 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
12d slower than avg
Panel avg: 122d · This submission: 134d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MQP Spinal Vertebral Body Replacement Device
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3060
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 - MQP Spinal Vertebral Body Replacement Device

All 161
Devices cleared under the same product code (MQP) and FDA review panel - the closest regulatory comparables to K052170.
STAXX XD SYSTEM
K052670 · Spine Wave, Inc. · Apr 2006
MODIFICATION TO VERTE-STACK SPINAL SYSTEM
K060719 · Medtronic Sofamor Danek · Apr 2006
CONSTRUX PL/TL PEEK PARTIAL VBR SYSTEM
K060350 · Blackstone Medical, Inc. · Feb 2006
NUVASIVE COROENT EXTENSURE SYSTEM
K052210 · Nuvasive, Inc. · Dec 2005
MODIFICATION TO VERTE-STACK SPINAL SYSTEM
K052931 · Medtronic Sofamor Danek · Nov 2005
STRYKER SPINE AVS ASL PEEK SPACER
K051205 · Stryker Spine · Nov 2005