Cleared Special

MOUNTAINEER OCT SPINAL SYSTEM (K103100) - FDA 510(k) Clearance

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K103100 · Depuy Spine, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2010
Decision
28d
Days
Class 2
Risk

K103100 is an FDA 510(k) clearance for the MOUNTAINEER OCT SPINAL SYSTEM. Classified as Orthosis, Spinal Pedicle Fixation (product code MNI), Class II - Special Controls.

Submitted by Depuy Spine, Inc. (Raynham, US). The FDA issued a Cleared decision on November 17, 2010 after a review of 28 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 Depuy Spine, Inc. devices

Submission Details

510(k) Number K103100 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 2010
Decision Date November 17, 2010
Days to Decision 28 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
94d faster than avg
Panel avg: 122d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 302
Devices cleared under the same product code (MNI) and FDA review panel - the closest regulatory comparables to K103100.
SYNTHES USS, CLICK'X, USS VAS, DUAL-OPENING USS AND SMALL STATURE USS
K022949 · Synthes (Usa) · Mar 2003
MODIFICATION TO SYNTHES CERVIFIX SYSTEM
K030377 · Synthes (Usa) · Mar 2003
SYNTHES DUAL-OPENING USS
K020517 · Synthes (Usa) · Apr 2002
MODIFIED USS FRACTURE SYSTEM
K010658 · Synthes (Usa) · Jun 2001
SMALL STATURE USS
K994121 · Synthes (Usa) · Oct 2000