Cleared Special

K021025 - MODIFICATION TO HEDROCEL VERTEBRAL BODY...

K021025 is the FDA 510(k) clearance for MODIFICATION TO HEDROCEL VERTEBRAL BODY... by Implex Corp.. It is a Class 2 Orthopedic device (product code MQP) cleared through the Special 510(k) pathway after a 52-day FDA review.

K021025 · Implex Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2002
Decision
52d
Days
Class 2
Risk

K021025 is an FDA 510(k) clearance for the MODIFICATION TO 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 May 20, 2002 after a review of 52 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 K021025 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 2002
Decision Date May 20, 2002
Days to Decision 52 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
70d faster than avg
Panel avg: 122d · This submission: 52d
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 K021025.
VERTE-STACK SPINAL SYSTEM
K021791 · Medtronic Sofamor Danek · Aug 2002
HEDROCEL VERTEBRAL BODY REPLACEMENT, MODELS 06-112-00XX2 AND 06-132-10XX2
K021967 · Implex Corp. · Jul 2002
VERTEBRAL SPACER
K011037 · Synthes (Usa) · Jul 2002
EBI AIS SPINE SYSTEM
K020887 · Ebi, L.P. · May 2002
SYNTHES VERTEBRAL SPACER TI
K020152 · Synthes (Usa) · Apr 2002
MODIFICATION TO SURGICAL TITANIUM MESH SYSTEM
K020522 · Depuyacromed · Mar 2002