Cleared Special

K060513 - SINTEA BIOTECH PLS MULTI-AXIAL SCREWS, MODEL PLS.XX.T5.X

K060513 is an FDA 510(k) clearance for SINTEA BIOTECH PLS MULTI-AXIAL SCREWS, manufactured by Sintea Biotech, Inc.. The device is a Class 2 Orthopedic device with product code KWP cleared through the Special 510(k) pathway after a 11-day FDA review.

K060513 · Sintea Biotech, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2006
Decision
11d
Days
Class 2
Risk

K060513 is an FDA 510(k) clearance for the SINTEA BIOTECH PLS MULTI-AXIAL SCREWS, MODEL PLS.XX.T5.X. Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by Sintea Biotech, Inc. (Miami Beach, US). The FDA issued a Cleared decision on March 10, 2006 after a review of 11 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 Sintea Biotech, Inc. devices

FDA 510(k) Submission Details - K060513

510(k) Number K060513 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 2006
Decision Date March 10, 2006
Days to Decision 11 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
111d faster than avg
Panel avg: 122d · This submission: 11d
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 350
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K060513.
SYNTHES OC FUSION SYSTEM
K053418 · Synthes Spine Co.Lp · Sep 2006
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K061579 · Medtronic Sofamor Danek · Aug 2006
ENDIUS MINIT POSTERIOR CERVICAL AND UPPER THORACIC FIXATION SYSTEM
K060683 · Endius, Inc. · Apr 2006
BASIS SPINAL SYSTEM
K060081 · Medtronic Sofamor Danek · Feb 2006
SOLANAS POSTERIOR STABILIZATION SYSTEM
K052201 · Alphatec Spine, Inc. · Nov 2005
MODIFICATION TO: VERTEX RECONSTRUCTION SYSTEM
K052734 · Medtronic Sofamor Danek · Oct 2005