Cleared Special

K081631 - SINTEA BIOTECH PLS MULTI-AXIAL SCREWS

K081631 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 MNH cleared through the Special 510(k) pathway after a 37-day FDA review.

K081631 · Sintea Biotech, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2008
Decision
37d
Days
Class 2
Risk

K081631 is an FDA 510(k) clearance for the SINTEA BIOTECH PLS MULTI-AXIAL SCREWS. Classified as Orthosis, Spondylolisthesis Spinal Fixation (product code MNH), Class II - Special Controls.

Submitted by Sintea Biotech, Inc. (Miami Beach, US). The FDA issued a Cleared decision on July 18, 2008 after a review of 37 days - a notably fast clearance cycle.

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. 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.

FDA 510(k) Submission Details - K081631

510(k) Number K081631 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 11, 2008
Decision Date July 18, 2008
Days to Decision 37 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
85d faster than avg
Panel avg: 122d · This submission: 37d
Pathway characteristics
Modification to existing cleared device.

MNH Device Classification - Class 2, Special Controls

Product Code MNH Orthosis, Spondylolisthesis Spinal 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 - MNH Orthosis, Spondylolisthesis Spinal Fixation

All 308
Devices cleared under the same product code (MNH) and FDA review panel - the closest regulatory comparables to K081631.
MODIFICATION TO PREFERENCE PEDICLE SCREW SYSTEM
K081883 · Us Spine · Sep 2008
4CIS SOLAR AND APOLLON SPINE SYSTEMS
K082453 · Solco Biomedical Co., Ltd. · Sep 2008
FIXXSURE CROSS LINK
K081331 · Spineworks, LLC · Jul 2008
MOUNTAINEER OCT SPINAL SYSTEM
K080828 · Depuy Spine, Inc. · Jun 2008
GPS, G SURGICAL PEDICLE SYSTEM
K081041 · G Surgical Co., Ltd. · Jun 2008
RANGE SPINAL SYSTEM, LARGE DENALI SCREWS
K081381 · K2m, Inc. · Jun 2008
K081631 · SINTEA BIOTECH PLS MULTI-AXIAL SCREWS
Download PDF FDA Summary Sintea Biotech, Inc.