Cleared Traditional

K002103 - SIMPLICITY SPINAL SYSTEM

K002103 is an FDA 510(k) clearance for SIMPLICITY SPINAL SYSTEM, manufactured by Medtronic Sofamor Danek USA, Inc.. The device is a Class 2 Orthopedic device with product code KWP cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K002103 · Medtronic Sofamor Danek USA, Inc. · Orthopedic device
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Nov 2000
Decision
113d
Days
Class 2
Risk

K002103 is an FDA 510(k) clearance for the SIMPLICITY SPINAL SYSTEM. Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by Medtronic Sofamor Danek USA, Inc. (Memphis, US). The FDA issued a Cleared decision on November 2, 2000 after a review of 113 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3050 - 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 Medtronic Sofamor Danek USA, Inc. devices

FDA 510(k) Submission Details - K002103

510(k) Number K002103 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 2000
Decision Date November 02, 2000
Days to Decision 113 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
9d faster than avg
Panel avg: 122d · This submission: 113d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KWP Device Classification - Class 2, Special Controls

Product Code KWP Appliance, Fixation, Spinal Interlaminal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3050
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 - KWP Appliance, Fixation, Spinal Interlaminal

All 383
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K002103.
PARSFIX CABLE-SCREW SYSTEM
K003351 · Spinal Concepts, Inc. · Jan 2001
ISOLA CLOSED DUAL ROD CONNECTOR
K003822 · Depuyacromed · Jan 2001
SUMMIT OCCIPITO-CERVICO-THORACIC (OCT) SPINAL SYSTEM
K002733 · Depuyacromed · Dec 2000
MODIFICATION TO ISOBAR SPINAL SYSTEM
K002959 · Encore Orthopedics, Inc. · Oct 2000
SPEEDLINK TRANSVERSE CONNECTOR
K002082 · Spinal Concepts, Inc. · Oct 2000
XIA SPINE SYSTEM
K002505 · Howmedica Osteonics Corp. · Oct 2000