Cleared Special

K011067 - MODIFICATION TO TSRH SPINAL SYSTEM

K011067 is an FDA 510(k) clearance for MODIFICATION TO TSRH SPINAL SYSTEM, manufactured by Medtronic Sofamor Danek, Inc.. The device is a Class 2 Orthopedic device with product code MNI cleared through the Special 510(k) pathway after a 25-day FDA review.

K011067 · Medtronic Sofamor Danek, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2001
Decision
25d
Days
Class 2
Risk

K011067 is an FDA 510(k) clearance for the MODIFICATION TO TSRH SPINAL SYSTEM. Classified as Orthosis, Spinal Pedicle Fixation (product code MNI), Class II - Special Controls.

Submitted by Medtronic Sofamor Danek, Inc. (Memphis, US). The FDA issued a Cleared decision on May 4, 2001 after a review of 25 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Medtronic Sofamor Danek, Inc. devices

FDA 510(k) Submission Details - K011067

510(k) Number K011067 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 09, 2001
Decision Date May 04, 2001
Days to Decision 25 days
Submission Type Special
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
97d faster than avg
Panel avg: 122d · This submission: 25d
Pathway characteristics
Modification to existing cleared device.

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 244
Devices cleared under the same product code (MNI) and FDA review panel - the closest regulatory comparables to K011067.
END-TO-END AND SIDE-BY-SIDE CONNECTORS
K010563 · Spinal Concepts, Inc. · May 2001
MONARCH SPINE SYSTEM
K010576 · Depuyacromed · May 2001
BLACKSTONE SPINAL FIXATION SYSTEM, SECOND-GENERATION CROSS-CONNECTOR
K003735 · Blackstone Medical, Inc. · May 2001
SMALL STATURE USS
K994121 · Synthes (Usa) · Oct 2000
TRI-FIX SPINAL FIXATION SYSTEM
K000766 · Endius, Inc. · Jun 2000
MULTI-AXIAL CROSS (MAC) CONNECTOR
K000965 · Howmedica Osteonics Corp. · May 2000