Cleared Traditional

K102636 - ZENITH PEDICLE SYSTEM

K102636 is an FDA 510(k) clearance for ZENITH PEDICLE SYSTEM, manufactured by Apollo Spine, Inc.. The device is a Class 2 Orthopedic device with product code MNH cleared through the Traditional 510(k) pathway after a 171-day FDA review.

K102636 · Apollo Spine, Inc. · Orthopedic device
Download Printable Device Report (PDF)
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Mar 2011
Decision
171d
Days
Class 2
Risk

K102636 is an FDA 510(k) clearance for the ZENITH PEDICLE SYSTEM. Classified as Orthosis, Spondylolisthesis Spinal Fixation (product code MNH), Class II - Special Controls.

Submitted by Apollo Spine, Inc. (Stoughton, US). The FDA issued a Cleared decision on March 3, 2011 after a review of 171 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3070 - 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 Apollo Spine, Inc. devices

FDA 510(k) Submission Details - K102636

510(k) Number K102636 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 2010
Decision Date March 03, 2011
Days to Decision 171 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
49d slower than avg
Panel avg: 122d · This submission: 171d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MNH Device Classification - Class 2, Special Controls

Product Code MNH Orthosis, Spondylolisthesis Spinal Fixation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3070
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 - MNH Orthosis, Spondylolisthesis Spinal Fixation

All 189
Devices cleared under the same product code (MNH) and FDA review panel - the closest regulatory comparables to K102636.
PASS LP SPINAL SYSTEM
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TIGER SPINE SYSTEM
K110321 · Corelink, LLC · May 2011
4CIS VANE SPINE SYSTEM
K101818 · Solco Biomedical Co., Ltd. · Feb 2011
VENUS BASIC SPINAL FIXATION SYSTEM
K103085 · L & K Biomed Co., Ltd. · Feb 2011
FLAMENCO SPINAL FIXATION SYSTEM
K102853 · Ulrich GmbH & Co. KG · Jan 2011