Cleared Traditional

K050979 - S4 SPINAL SYSTEM

K050979 is the FDA 510(k) clearance for S4 SPINAL SYSTEM by Aesculap, Inc.. It is a Class 2 Orthopedic device (product code MNI) cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K050979 · Aesculap, Inc. · Orthopedic device
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Jul 2005
Decision
99d
Days
Class 2
Risk

K050979 is an FDA 510(k) clearance for the S4 SPINAL SYSTEM. Classified as Orthosis, Spinal Pedicle Fixation (product code MNI), Class II - Special Controls.

Submitted by Aesculap, Inc. (Center Valley, US). The FDA issued a Cleared decision on July 27, 2005 after a review of 99 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 Aesculap, Inc. devices

Submission Details

510(k) Number K050979 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 19, 2005
Decision Date July 27, 2005
Days to Decision 99 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
23d faster than avg
Panel avg: 122d · This submission: 99d
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 K050979.
STRYKER SPINE TRIO SPINAL FIXATION SYSTEM
K052971 · Stryker Spine · Nov 2005
MODIFICATION TO: XIA 4.5 SPINAL SYSTEM
K052761 · Stryker Spine · Oct 2005
MODIFICATION TO: STRYKER SPINE OASYS SYSTEM
K052317 · Stryker Spine · Sep 2005
CD HORIZON SPINAL SYSTEM
K050981 · Medtronic Sofamor Danek USA, Inc. · May 2005
EXPEDIUM SPINE SYSTEM SPINOUS PROCESS FUSION PLATE
K050675 · Depuy Spine, Inc. · Apr 2005
MSD SILO SPINAL SYSTEM
K042210 · Medtronic Sofamor Danek · Nov 2004