Cleared Special

K070300 - EXPEDIUM SFX CROSS CONNECTOR SYSTEM

K070300 is an FDA 510(k) clearance for EXPEDIUM SFX CROSS CONNECTOR SYSTEM, manufactured by Depuy Spine, Inc.. The device is a Class 2 Orthopedic device with product code KWP cleared through the Special 510(k) pathway after a 69-day FDA review.

K070300 · Depuy Spine, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2007
Decision
69d
Days
Class 2
Risk

K070300 is an FDA 510(k) clearance for the EXPEDIUM SFX CROSS CONNECTOR SYSTEM. Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by Depuy Spine, Inc. (Raynham, US). The FDA issued a Cleared decision on April 10, 2007 after a review of 69 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3050 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Depuy Spine, Inc. devices

FDA 510(k) Submission Details - K070300

510(k) Number K070300 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 2007
Decision Date April 10, 2007
Days to Decision 69 days
Submission Type Special
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
53d faster than avg
Panel avg: 122d · This submission: 69d
Pathway characteristics
Modification to existing cleared device.

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 365
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K070300.
LDR SPINE EASYSPINE POSTERIOR OSTEOSYNTHESIS SYSTEM
K070341 · Ldr Spine USA · Aug 2007
POLARIS BE RODS
K071377 · Biomet Spine · Aug 2007
THEKEN ATOLL CERVICO-THORACIC SYSTEM
K070638 · Theken Spine, LLC · May 2007
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K061591 · Medtronic Sofamor Danek, Inc. · Sep 2006
SYNTHES OC FUSION SYSTEM
K053418 · Synthes Spine Co.Lp · Sep 2006
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K061579 · Medtronic Sofamor Danek · Aug 2006