Cleared Traditional

K072434 - SYNTHES OC FUSION AND SYNAPSE SYSTEMS

K072434 is an FDA 510(k) clearance for SYNTHES OC FUSION AND SYNAPSE SYSTEMS, manufactured by Synthes Spine Co.Lp. The device is a Class 2 Orthopedic device with product code MNI cleared through the Traditional 510(k) pathway after a 134-day FDA review.

K072434 · Synthes Spine Co.Lp · Orthopedic device
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Jan 2008
Decision
134d
Days
Class 2
Risk

K072434 is an FDA 510(k) clearance for the SYNTHES OC FUSION AND SYNAPSE SYSTEMS. Classified as Orthosis, Spinal Pedicle Fixation (product code MNI), Class II - Special Controls.

Submitted by Synthes Spine Co.Lp (West Chester, US). The FDA issued a Cleared decision on January 10, 2008 after a review of 134 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 Co.Lp devices

FDA 510(k) Submission Details - K072434

510(k) Number K072434 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 2007
Decision Date January 10, 2008
Days to Decision 134 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
12d slower than avg
Panel avg: 122d · This submission: 134d
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 192
Devices cleared under the same product code (MNI) and FDA review panel - the closest regulatory comparables to K072434.
BLACKSTONE SFS PARALLEL ROD CONNECTORS
K080407 · Blackstone Medical, Inc. · Mar 2008
MODIFICATION TO STRYKER SPINE OASYS SYSTEM
K080143 · Stryker Spine · Feb 2008
QUANTUM-MIS CANNULATED SYSTEM
K080026 · Pioneer Surgical Technology · Jan 2008
NATURAL BRIDGE LP TRANSVERSE CONNECTORS
K072914 · K2m, Inc. · Jan 2008
PIONEER LOWTOP SPINAL ROD SYSTEM
K072187 · Pioneer Surgical Technology · Oct 2007
Optima ZS Transition Screw
K071880 · Zimmer Spine, Inc. · Oct 2007