Cleared Traditional

K071438 - PSS SYSTEM

K071438 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 Traditional 510(k) pathway after a 90-day FDA review.

K071438 · Spinal USA · Orthopedic device
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Aug 2007
Decision
90d
Days
Class 2
Risk

K071438 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 August 21, 2007 after a review of 90 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 Spinal USA devices

FDA 510(k) Submission Details - K071438

510(k) Number K071438 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 2007
Decision Date August 21, 2007
Days to Decision 90 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
32d faster than avg
Panel avg: 122d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 288
Devices cleared under the same product code (MNI) and FDA review panel - the closest regulatory comparables to K071438.
LANX SPINAL FIXATION SYSTEM
K071877 · Lanx, LLC · Sep 2007
ACME TALON PEDICLE SCREW
K071824 · Acme Spine, LLC · Sep 2007
VERTEFIX PEDICLE SCREW SPINAL SYSTEM
K063453 · Elite Surgical Supplies (Pty), Ltd. · Aug 2007
DELTA SPINAL FUSION SYSTEM
K071857 · Jemo Spine, LLC · Aug 2007
NUVASIVE OCT SYSTEM
K071435 · Nuvasive, Inc. · Aug 2007
PILLAR PEDICLE SCREW SYSTEM
K071743 · The 4th Column, LLC · Jul 2007