Cleared Traditional

K083178 - SOLAS ANATOMIX SPINAL SYSTEM

K083178 is an FDA 510(k) clearance for SOLAS ANATOMIX SPINAL SYSTEM, manufactured by Biotechni America Spine Group, Inc.. The device is a Class 2 Orthopedic device with product code MNI cleared through the Traditional 510(k) pathway after a 118-day FDA review.

K083178 · Biotechni America Spine Group, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2009
Decision
118d
Days
Class 2
Risk

K083178 is an FDA 510(k) clearance for the SOLAS ANATOMIX SPINAL SYSTEM. Classified as Orthosis, Spinal Pedicle Fixation (product code MNI), Class II - Special Controls.

Submitted by Biotechni America Spine Group, Inc. (Seattle, US). The FDA issued a Cleared decision on February 23, 2009 after a review of 118 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 Biotechni America Spine Group, Inc. devices

FDA 510(k) Submission Details - K083178

510(k) Number K083178 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 2008
Decision Date February 23, 2009
Days to Decision 118 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
4d faster than avg
Panel avg: 122d · This submission: 118d
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 201
Devices cleared under the same product code (MNI) and FDA review panel - the closest regulatory comparables to K083178.
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PILOT SPINAL SYSTEM
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CAPSURE PS SYSTEM
K083743 · Spine Wave, Inc. · Jan 2009
CAPSURE(R) PS SYSTEM
K083353 · Spine Wave, Inc. · Dec 2008