Cleared Special

K073240 - PSS SYSTEM

K073240 is an FDA 510(k) clearance for PSS SYSTEM, manufactured by Spinal USA. The device is a Class 2 Orthopedic device with product code MNI cleared through the Special 510(k) pathway after a 125-day FDA review.

K073240 · Spinal USA · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2008
Decision
125d
Days
Class 2
Risk

K073240 is an FDA 510(k) clearance for the PSS SYSTEM. Classified as Orthosis, Spinal Pedicle Fixation (product code MNI), Class II - Special Controls.

Submitted by Spinal USA (Flowood, US). The FDA issued a Cleared decision on March 20, 2008 after a review of 125 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. 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Spinal USA devices

FDA 510(k) Submission Details - K073240

510(k) Number K073240 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 2007
Decision Date March 20, 2008
Days to Decision 125 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
3d slower than avg
Panel avg: 122d · This submission: 125d
Pathway characteristics
Modification to existing cleared device.

MNI Device Classification - Class 2, Special Controls

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 184
Devices cleared under the same product code (MNI) and FDA review panel - the closest regulatory comparables to K073240.
CAPSURE PS (R) SPINE SYSTEM
K081228 · Spine Wave, Inc. · May 2008
MODIFICATION TO:PILOT SPINAL SYSTEM
K080502 · Life Spine · Apr 2008
K2M COCR ROD
K080792 · K2m, Inc. · Apr 2008
BLACKSTONE SFS PARALLEL ROD CONNECTORS
K080407 · Blackstone Medical, Inc. · Mar 2008
MODIFICATION TO STRYKER SPINE OASYS SYSTEM
K080143 · Stryker Spine · Feb 2008
QUANTUM-MIS CANNULATED SYSTEM
K080026 · Pioneer Surgical Technology · Jan 2008