Cleared Traditional

K113149 - SYNTHES USS CONNECTORS

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

K113149 · Synthes Spine · Orthopedic device
Download Printable Device Report (PDF)
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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

FDA 510(k) Submission Details - K113149

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.

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 266
Devices cleared under the same product code (MNI) and FDA review panel - the closest regulatory comparables to K113149.
TIGER SPINE SYSTEM
K120696 · Corelink, LLC · Apr 2012
PALLS M SPINAL SYSTEM
K120538 · Korea Bone Bank Co., Ltd. · Mar 2012
AILERON INTERSPINOUS FIXATION SYSTEM
K113157 · Life Spine · Mar 2012
SAVANNAH TECHNOLOGIES SPINAL SYSTEM
K113755 · Savannah Technologies, LLC · Feb 2012
RELIANCE SPINAL SCREW SYSTEM
K110896 · Reliance Medical Systems, LLC · Jan 2012
RANGE SPINAL SYSTEM (MESA AND DENALI)
K112920 · K2m, Inc. · Dec 2011