Cleared Traditional

K013312 - P.L.U.S. SYSTEM (PIVOT LINK UNIVERSAL SYSTEM)

K013312 is an FDA 510(k) clearance for P.L.U.S. SYSTEM (PIVOT LINK UNIVERSAL S..., manufactured by Spine Vision, Inc.. The device is a Class 2 Orthopedic device with product code KWP cleared through the Traditional 510(k) pathway after a 132-day FDA review.

K013312 · Spine Vision, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2002
Decision
132d
Days
Class 2
Risk

K013312 is an FDA 510(k) clearance for the P.L.U.S. SYSTEM (PIVOT LINK UNIVERSAL SYSTEM). Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by Spine Vision, Inc. (Atlanta, US). The FDA issued a Cleared decision on February 13, 2002 after a review of 132 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3050 - 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 Spine Vision, Inc. devices

FDA 510(k) Submission Details - K013312

510(k) Number K013312 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 2001
Decision Date February 13, 2002
Days to Decision 132 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
10d slower than avg
Panel avg: 122d · This submission: 132d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 358
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K013312.
ENDIUS SPINAL FIXATION SYSTEM
K014090 · Endius, Inc. · Mar 2002
MSD WIRE SYSTEM
K020426 · Medtronic Sofamor Danek, Inc. · Feb 2002
MODIFICATION TO PASS SPINAL SYSTEM
K020236 · Encore Orthopedics, Inc. · Feb 2002
DYNA-LOK CLASSIC SPINAL SYSTEM
K020155 · Medtronic Sofamor Danek · Feb 2002
BUTTERFLY PLATE FIXATION SYSTEM
K014267 · Medtronic Sofamor Danek, Inc. · Jan 2002
PASS SPINAL SYSTEM
K013442 · Encore Orthopedics, Inc. · Jan 2002