Cleared Traditional

K083863 - THEKEN ATOLL OCT SPINAL SYSTEM

K083863 is an FDA 510(k) clearance for THEKEN ATOLL OCT SPINAL SYSTEM, manufactured by Theken Spine, LLC. The device is a Class 2 Orthopedic device with product code MNI cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K083863 · Theken Spine, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2009
Decision
88d
Days
Class 2
Risk

K083863 is an FDA 510(k) clearance for the THEKEN ATOLL OCT SPINAL SYSTEM. Classified as Orthosis, Spinal Pedicle Fixation (product code MNI), Class II - Special Controls.

Submitted by Theken Spine, LLC (Akron, US). The FDA issued a Cleared decision on March 27, 2009 after a review of 88 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Theken Spine, LLC devices

FDA 510(k) Submission Details - K083863

510(k) Number K083863 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 2008
Decision Date March 27, 2009
Days to Decision 88 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
34d faster than avg
Panel avg: 122d · This submission: 88d
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 184
Devices cleared under the same product code (MNI) and FDA review panel - the closest regulatory comparables to K083863.
ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM
K091189 · Alphatec Spine, Inc. · Jul 2009
ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM
K090779 · Alphatec Spine, Inc. · Jul 2009
MODIFICATION TO: PSS SYSTEM
K090033 · Spinal USA · May 2009
RELIANCE SPINAL SCREW SYSTEM
K081978 · Reliance Medical Systems, LLC · Mar 2009
THEKEN ATOLL CERVICO-THORACIC SYSTEM
K083073 · Theken Spine, LLC · Mar 2009
PILOT SPINAL SYSTEM
K083865 · Life Spine · Jan 2009