Cleared Special

K021967 - HEDROCEL VERTEBRAL BODY REPLACEMENT

K021967 is the FDA 510(k) clearance for HEDROCEL VERTEBRAL BODY REPLACEMENT by Implex Corp.. It is a Class 2 Orthopedic device (product code MQP) cleared through the Special 510(k) pathway after a 30-day FDA review.

K021967 · Implex Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2002
Decision
30d
Days
Class 2
Risk

K021967 is an FDA 510(k) clearance for the HEDROCEL VERTEBRAL BODY REPLACEMENT, MODELS 06-112-00XX2 AND 06-132-10XX2. 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 July 17, 2002 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3060 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Implex Corp. devices

Submission Details

510(k) Number K021967 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 2002
Decision Date July 17, 2002
Days to Decision 30 days
Submission Type Special
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
92d faster than avg
Panel avg: 122d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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 152
Devices cleared under the same product code (MQP) and FDA review panel - the closest regulatory comparables to K021967.
MODIFICATION TO VERTE-STACK SPINAL SYSTEM
K023570 · Medtronic Sofamor Danek · Nov 2002
HYDROCEL VERTEBRAL BODY REPLACEMENT, MODEL 06-172-00XX1
K022563 · Implex Corp. · Aug 2002
VERTE-STACK SPINAL SYSTEM
K021791 · Medtronic Sofamor Danek · Aug 2002
VERTEBRAL SPACER
K011037 · Synthes (Usa) · Jul 2002
MODIFICATION TO HEDROCEL VERTEBRAL BODY REPLACEMENT, MODEL XX-YYY-ZZZZ
K021025 · Implex Corp. · May 2002
EBI AIS SPINE SYSTEM
K020887 · Ebi, L.P. · May 2002