Cleared Traditional

K020085 - SINTEA BIOTECH POSTERIOR LUMBAR SYSTEM, MODEL PLS 00.T5.X

K020085 is an FDA 510(k) clearance for SINTEA BIOTECH POSTERIOR LUMBAR SYSTEM, manufactured by Sintea Biotech, Inc.. The device is a Class 2 Orthopedic device with product code MNH cleared through the Traditional 510(k) pathway after a 334-day FDA review.

K020085 · Sintea Biotech, Inc. · Orthopedic device
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Dec 2002
Decision
334d
Days
Class 2
Risk

K020085 is an FDA 510(k) clearance for the SINTEA BIOTECH POSTERIOR LUMBAR SYSTEM, MODEL PLS 00.T5.X. 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 December 10, 2002 after a review of 334 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Sintea Biotech, Inc. devices

FDA 510(k) Submission Details - K020085

510(k) Number K020085 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 10, 2002
Decision Date December 10, 2002
Days to Decision 334 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
212d slower than avg
Panel avg: 122d · This submission: 334d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 201
Devices cleared under the same product code (MNH) and FDA review panel - the closest regulatory comparables to K020085.
MODIFICATION TO MOSS MIAMI SPINAL SYSTEM POLYAXIAL SCREWS
K030383 · Depuyacromed · Feb 2003
ORIA SPINAL CLIP SYSTEM, TYPES BD AND BJ
K023994 · Ortho Tec, LLC · Feb 2003
MONARCH SPINE SYSTEM
K024348 · Depuyacromed · Jan 2003
MODIFICATION TO MONARCH SPINE SYSTEM
K023438 · Depuyacromed · Nov 2002
MODIFICATION TO EBI OMEGA21 SPINAL FIXATION SYSTEM
K023204 · Ebi, L.P. · Oct 2002
ENDIUS TITLE SPINAL FIXATION SYSTEM
K021881 · Endius, Inc. · Jul 2002