Cleared Traditional

K031782 - GAPP GRAFT CONTIANMENT DEVICE ORTHOPEDICS

K031782 is the FDA 510(k) clearance for GAPP GRAFT CONTIANMENT DEVICE ORTHOPEDICS by Medtronic Sofamor Danek. It is a Class 2 Orthopedic device (product code KWQ) cleared through the Traditional 510(k) pathway after a 602-day FDA review.

K031782 · Medtronic Sofamor Danek · Orthopedic device
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Optimized for regulatory review, auditing and printing
Feb 2005
Decision
602d
Days
Class 2
Risk

K031782 is an FDA 510(k) clearance for the GAPP GRAFT CONTIANMENT DEVICE ORTHOPEDICS. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Medtronic Sofamor Danek (Memphis, US). The FDA issued a Cleared decision on February 1, 2005 after a review of 602 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3060 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Orthopedic submissions.

View all Medtronic Sofamor Danek devices

Submission Details

510(k) Number K031782 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 2003
Decision Date February 01, 2005
Days to Decision 602 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
480d slower than avg
Panel avg: 122d · This submission: 602d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KWQ Appliance, Fixation, Spinal Intervertebral Body
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3060
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 - KWQ Appliance, Fixation, Spinal Intervertebral Body

All 438
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K031782.
MODIFICATION TO: SPECTRUMTM CERVICAL SPINAL SYSTEM
K050804 · Aesculap, Inc. · Apr 2005
MODIFICATION TO PYRAMID ANTERIOR PLATE FIXATION SYSTEM
K050117 · Medtronic Sofamor Danek · Feb 2005
PIONEER ANTERIOR CERVICAL PLATE SYSTEM
K043066 · Pioneer Surgical Technology · Feb 2005
MODIFICATION TO: CD HORIZON SPINAL SYSTEM
K043151 · Medtronic Sofamor Danek · Feb 2005
UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM
K042544 · Depuy Spine, Inc. · Nov 2004
VENTURE ANTERIOR CERVICAL PLATING SYSTEM
K042922 · Medtronic Sofamor Danek, Inc. · Nov 2004