Cleared Traditional

K110259 - ARCHITEX SPACE MAINTENANCE SYSTEM

K110259 is the FDA 510(k) clearance for ARCHITEX SPACE MAINTENANCE SYSTEM by Medtronic Sofamor Danek USA, Inc.. It is a Class 2 Dental device (product code JEY) cleared through the Traditional 510(k) pathway after a 75-day FDA review.

K110259 · Medtronic Sofamor Danek USA, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2011
Decision
75d
Days
Class 2
Risk

K110259 is an FDA 510(k) clearance for the ARCHITEX SPACE MAINTENANCE SYSTEM. Classified as Plate, Bone (product code JEY), Class II - Special Controls.

Submitted by Medtronic Sofamor Danek USA, Inc. (Memphis, US). The FDA issued a Cleared decision on April 13, 2011 after a review of 75 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4760 - the FDA dental 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 Medtronic Sofamor Danek USA, Inc. devices

Submission Details

510(k) Number K110259 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 28, 2011
Decision Date April 13, 2011
Days to Decision 75 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
52d faster than avg
Panel avg: 127d · This submission: 75d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JEY Plate, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.4760
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 Dental devices follow this clearance model.

Regulatory Peers - JEY Plate, Bone

All 157
Devices cleared under the same product code (JEY) and FDA review panel - the closest regulatory comparables to K110259.
SMARTBUILDER SYSTEM
K120951 · Osstem Implant Co., Ltd. · Oct 2012
ARTISAN SPACE MAINTENANCE SYSTEM
K120271 · Medtronic Sofamor Danek USA, Inc. · May 2012
RESORB X-G
K112064 · KLS-Martin L.P. · Mar 2012
SURGICASE CMF, SURGICASE CONNECT, SURGICASE GUIDE
K103136 · Materialise NV · Mar 2011
LEFORTE NEURO SYSTEM BONE PLATE
K103778 · Jeil Medical Corporation · Jan 2011
SYNTHES DENTOALVEOLAR BONE FIXATION SYSTEM
K102656 · Synthes (Usa) · Dec 2010