Cleared Special

K043355 - SINTEA BIOTECH POSTERIOR LUMBAR SYSTEM WITH POLYAXIAL AND RECOVERY SCREWS, MODEL PLS.01.T5.X

K043355 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 KWP cleared through the Special 510(k) pathway after a 11-day FDA review.

K043355 · Sintea Biotech, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2004
Decision
11d
Days
Class 2
Risk

K043355 is an FDA 510(k) clearance for the SINTEA BIOTECH POSTERIOR LUMBAR SYSTEM WITH POLYAXIAL AND RECOVERY SCREWS, MO.... 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 December 17, 2004 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.

FDA 510(k) Submission Details - K043355

510(k) Number K043355 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 2004
Decision Date December 17, 2004
Days to Decision 11 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
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 421
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K043355.
GLAXY 3.2 SPINAL SYSTEM
K043020 · Medtronic Sofamor Danek · Jan 2005
VERTEX RECONSTRUCTION SYSTEM
K042789 · Medtronic Sofamor Danek · Dec 2004
MODIFICATION TO ALTIUS OCT SYSTEM
K043229 · Interpore Cross Intl. · Dec 2004
ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM
K042673 · Alphatec/Nexmed · Oct 2004
MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM
K042524 · Medtronic Sofamor Danek · Oct 2004
EXCELLA-M SPINAL SYSTEM
K042143 · Innovasis, Inc. · Oct 2004
K043355 · SINTEA BIOTECH POSTERIOR LUMBAR SYSTEM WITH POLYAXIAL AND RECOVERY SCREWS, MODEL PLS.01.T5.X
Download PDF FDA Summary Sintea Biotech, Inc.