Cleared Traditional

HALM ZIELKE INSTRUMENTATION SYSTEM (K024125) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K024125 · Micomed Ortho GmbH · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2003
Decision
280d
Days
Class 2
Risk

K024125 is an FDA 510(k) clearance for the HALM ZIELKE INSTRUMENTATION SYSTEM. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Micomed Ortho GmbH (San Diego, US). The FDA issued a Cleared decision on September 22, 2003 after a review of 280 days - an extended review cycle.

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 Micomed Ortho GmbH devices

Submission Details

510(k) Number K024125 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 2002
Decision Date September 22, 2003
Days to Decision 280 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
158d slower than avg
Panel avg: 122d · This submission: 280d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KWQ Appliance, Fixation, Spinal Intervertebral Body
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 - KWQ Appliance, Fixation, Spinal Intervertebral Body

All 239
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K024125.
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K040962 · Medtronic Sofamor Danek · May 2004
SYNTHES VENTROFIX MIS SYSTEM
K031100 · Synthes (Usa) · Mar 2004
SYNTHES ANTERIOR CERVICAL COMPRESSION SYSTEM
K033844 · Synthes (Usa) · Feb 2004
CD HORIZON SPINAL SYSTEM
K032265 · Medtronic Sofamor Danek · Aug 2003
MODIFICATION TO MACS MODULAR ANTERIOR CONSTRUCT SYSTEM
K032059 · Aesculap, Inc. · Jul 2003
SYNTHES ANTERIOR CERVICAL LOCKING PLATE (ACLP) SYSTEM
K031276 · Synthes (Usa) · Jul 2003