Cleared Traditional

K071668 - ORTHOBIOM SPINAL SYSTEM

K071668 is an FDA 510(k) clearance for ORTHOBIOM SPINAL SYSTEM, manufactured by Paradigm Spine. The device is a Class 2 Orthopedic device with product code MNI cleared through the Traditional 510(k) pathway after a 379-day FDA review.

K071668 · Paradigm Spine · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K071668

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.

MNI Device Classification - Class 2, Special Controls

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 192
Devices cleared under the same product code (MNI) and FDA review panel - the closest regulatory comparables to K071668.
CAPSURE(R) PS SYSTEM
K083353 · Spine Wave, Inc. · Dec 2008
COSMIC SYSTEM
K080841 · Ulrich GmbH & Co. KG · Jul 2008
ZODIC POLYAXIAL SPINAL FIXATION SYSTEM
K081158 · Alphatec Spine, Inc. · Jul 2008
CONQUEST SPINAL SYSTEM
K080767 · Life Spine · May 2008
CAPSURE PS (R) SPINE SYSTEM
K081228 · Spine Wave, Inc. · May 2008
MODIFICATION TO:PILOT SPINAL SYSTEM
K080502 · Life Spine · Apr 2008