Cleared Traditional

ORTHOBIOM SPINAL SYSTEM (K071668) - FDA 510(k) Clearance

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

K071668 · Paradigm Spine · Orthopedic device
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Jul 2008
Decision
379d
Days
Class 2
Risk

K071668 is an FDA 510(k) clearance for the ORTHOBIOM SPINAL SYSTEM. Classified as Orthosis, Spinal Pedicle Fixation (product code MNI), Class II - Special Controls.

Submitted by Paradigm Spine (New York, US). The FDA issued a Cleared decision on July 2, 2008 after a review of 379 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Paradigm Spine devices

Submission Details

510(k) Number K071668 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 2007
Decision Date July 02, 2008
Days to Decision 379 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
257d slower than avg
Panel avg: 122d · This submission: 379d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MNI Orthosis, Spinal Pedicle 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 - MNI Orthosis, Spinal Pedicle Fixation

All 56
Devices cleared under the same product code (MNI) and FDA review panel - the closest regulatory comparables to K071668.
EVEREST SPINAL SYSTEM
K103440 · K2m, Inc. · Mar 2011
RANGE SPINAL SYSTEM
K100851 · K2m, Inc. · Aug 2010
CASPIAN SPINAL SYSTEM
K092640 · K2m, Inc. · Nov 2009
K2M COCR ROD
K080792 · K2m, Inc. · Apr 2008
NATURAL BRIDGE LP TRANSVERSE CONNECTORS
K072914 · K2m, Inc. · Jan 2008
RANGE SPINAL SYSTEM
K070229 · K2m, Inc. · May 2007