Cleared Traditional

K010378 - HEDROCEL VERTEBRAL BODY REPLACEMENT, MODEL XX-YYY-ZZZZ

K010378 is an FDA 510(k) clearance for HEDROCEL VERTEBRAL BODY REPLACEMENT, manufactured by Implex Corp.. The device is a Class 2 Orthopedic device with product code MQP cleared through the Traditional 510(k) pathway after a 354-day FDA review.

K010378 · Implex Corp. · Orthopedic device
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Jan 2002
Decision
354d
Days
Class 2
Risk

K010378 is an FDA 510(k) clearance for the HEDROCEL VERTEBRAL BODY REPLACEMENT, MODEL XX-YYY-ZZZZ. Classified as Spinal Vertebral Body Replacement Device (product code MQP), Class II - Special Controls.

Submitted by Implex Corp. (Allendale, US). The FDA issued a Cleared decision on January 28, 2002 after a review of 354 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Implex Corp. devices

FDA 510(k) Submission Details - K010378

510(k) Number K010378 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 2001
Decision Date January 28, 2002
Days to Decision 354 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
232d slower than avg
Panel avg: 122d · This submission: 354d
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 237
Devices cleared under the same product code (MQP) and FDA review panel - the closest regulatory comparables to K010378.
MODIFICATION TO SURGICAL TITANIUM MESH SYSTEM
K020522 · Depuyacromed · Mar 2002
TELESCOPIC PLATE SPACER THORACOLUMBAR (TPS-TL) SPINAL SYSTEM, MODELS 8123, 8124, 8132, 8133, 8156, 8157, 8158, & 8189
K020204 · Interpore Cross Intl. · Feb 2002
MODIFICATION TO GEO STRUCTURE
K020048 · Interpore Cross Intl. · Feb 2002
MODIFICATION TO TELESCOPIC PLATE SPACER THORACOLUMBAR (TPS-TL) SPINAL SYSTEM, MODEL 8130, 8131
K014145 · Interpore Cross Intl. · Jan 2002
SPINAL MESH SYSTEM
K011406 · Medtronic Sofamor Danek, Inc. · Dec 2001
TELESCOPIC PLATE SPACER THORACOLUMBAR (TPS-TL) SPINAL, MODEL 8119, 8120, 8130, 8131
K010989 · Interpore Cross Intl. · Nov 2001