Cleared Traditional

K061524 - ISS INTEGRATED SPINE SYSTEM

K061524 is the FDA 510(k) clearance for ISS INTEGRATED SPINE SYSTEM by Ortho Development Corp.. It is a Class 2 Orthopedic device (product code MNH) cleared through the Traditional 510(k) pathway after a 116-day FDA review.

K061524 · Ortho Development Corp. · Orthopedic device
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Sep 2006
Decision
116d
Days
Class 2
Risk

K061524 is an FDA 510(k) clearance for the ISS INTEGRATED SPINE SYSTEM. Classified as Orthosis, Spondylolisthesis Spinal Fixation (product code MNH), Class II - Special Controls.

Submitted by Ortho Development Corp. (Draper, US). The FDA issued a Cleared decision on September 26, 2006 after a review of 116 days - within the typical 510(k) review window.

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 Ortho Development Corp. devices

Submission Details

510(k) Number K061524 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 2006
Decision Date September 26, 2006
Days to Decision 116 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
6d faster than avg
Panel avg: 122d · This submission: 116d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 154
Devices cleared under the same product code (MNH) and FDA review panel - the closest regulatory comparables to K061524.
ZODIAC 4.0 POLYAXIAL SPINAL FIXATION SYSTEM
K071890 · Alphatec Spine, Inc. · Nov 2007
CAPLESS LI PEDICLE SCREW SYSTEM
K072282 · X-Spine Systems, Inc. · Sep 2007
MODIFICATION TO EXPEDIUM SPINE SYSTEM
K062174 · Depuy Spine, Inc. · Nov 2006
MANTIS SPINAL SYSTEM
K061813 · Stryker Spine · Sep 2006
SFX SNAP-FIT CROSS CONNECTOR
K062196 · Depuy Spine, Inc. · Sep 2006
PILOT POSTERIOR LUMBAR PLATING SYSTEM
K061364 · Life Spine · Sep 2006