Cleared Traditional

K113149 - SYNTHES USS CONNECTORS

K113149 is the FDA 510(k) clearance for SYNTHES USS CONNECTORS by Synthes Spine. It is a Class 2 Orthopedic device (product code MNI) cleared through the Traditional 510(k) pathway after a 100-day FDA review.

K113149 · Synthes Spine · Orthopedic device
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Feb 2012
Decision
100d
Days
Class 2
Risk

K113149 is an FDA 510(k) clearance for the SYNTHES USS CONNECTORS. Classified as Orthosis, Spinal Pedicle Fixation (product code MNI), Class II - Special Controls.

Submitted by Synthes Spine (West Chester, US). The FDA issued a Cleared decision on February 1, 2012 after a review of 100 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 Synthes Spine devices

Submission Details

510(k) Number K113149 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 24, 2011
Decision Date February 01, 2012
Days to Decision 100 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
22d faster than avg
Panel avg: 122d · This submission: 100d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 159
Devices cleared under the same product code (MNI) and FDA review panel - the closest regulatory comparables to K113149.
EVEREST SPINAL SYSTEM
K120656 · K2m, Inc. · Apr 2012
TIGER SPINE SYSTEM
K120696 · Corelink, LLC · Apr 2012
AILERON INTERSPINOUS FIXATION SYSTEM
K113157 · Life Spine · Mar 2012
RANGE SPINAL SYSTEM (MESA AND DENALI)
K112920 · K2m, Inc. · Dec 2011
RANGE SPINAL SYSTEM (MESA AND DENALI)
K112037 · K2m, Inc. · Oct 2011
CAPSURE(R) PS SYSTEM
K111913 · Spine Wave, Inc. · Aug 2011