Cleared Traditional

K111136 - EXPEDIUM SPINE SYSTEM

K111136 is the FDA 510(k) clearance for EXPEDIUM SPINE SYSTEM by Depuy Spine, Inc.. It is a Class 2 Orthopedic device (product code NKB) cleared through the Traditional 510(k) pathway after a 419-day FDA review.

K111136 · Depuy Spine, Inc. · Orthopedic device
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Jun 2012
Decision
419d
Days
Class 2
Risk

K111136 is an FDA 510(k) clearance for the EXPEDIUM SPINE SYSTEM, VIPER SYSTEM, VIPER 2 SYSTEM. Classified as Thoracolumbosacral Pedicle Screw System within the NKB classification (a category for thoracolumbosacral pedicle screw systems), Class II - Special Controls.

Submitted by Depuy Spine, Inc. (Raynham, US). The FDA issued a Cleared decision on June 14, 2012 after a review of 419 days - an unusually long review period, suggesting complex equivalence evaluation.

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: 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 Depuy Spine, Inc. devices

Submission Details

510(k) Number K111136 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received April 22, 2011
Decision Date June 14, 2012
Days to Decision 419 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
297d slower than avg
Panel avg: 122d · This submission: 419d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NKB Thoracolumbosacral Pedicle Screw System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3070
Definition Intended To Provide Immobilization And Stabilization Of Spinal Segments In Thoracic, Lumbar, And Sacral Spine As An Adjunct To Fusion.
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 - NKB Thoracolumbosacral Pedicle Screw System

All 614
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K111136.
BEACON STABILIZATION SYSTEM
K121922 · Globus Medical, Inc. · Jul 2012
CD HORIZON SPINAL SYSTEM
K121680 · Medtronic Sofamor Danek USA, Inc. · Jul 2012
XIA 4.5 SPINAL SYSTEM
K121342 · Stryker Corp. · Jun 2012
REVERE 4.5 STABILIZATION SYSTEM
K113395 · Globus Medical, Inc. · Jun 2012
VIPER SYSTEM
K121020 · Depuy Spine, Inc. · May 2012
VENUS SPINAL FIXATION SYSTEM
K120270 · L & K Biomed Co., Ltd. · Mar 2012