Cleared Traditional

K052170 - SEASPINE VBR SYSTEM

K052170 is an FDA 510(k) clearance for SEASPINE VBR SYSTEM, manufactured by Seaspine, Inc.. The device is a Class 2 Orthopedic device with 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

FDA 510(k) Submission Details - K052170

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.

MQP Device Classification - Class 2, Special Controls

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 272
Devices cleared under the same product code (MQP) and FDA review panel - the closest regulatory comparables to K052170.
ARX SPINAL SYSTEM
K051525 · Amedica Corp. · Feb 2006
SYNFIX-LR
K053508 · Synthes Spine Co.Lp · Feb 2006
DAVANTIS/ANTELYS VERTEBRAL BODY REPLACEMENTS
K053292 · Scient'X USA, Inc. · Jan 2006
GRAFTCAGE TLX
K051781 · Osteotech, Inc. · Dec 2005
NUVASIVE COROENT EXTENSURE SYSTEM
K052210 · Nuvasive, Inc. · Dec 2005
GRAFTCAGE ACX
K053080 · Osteotech, Inc. · Dec 2005