Cleared Special

K090839 - MODIFICATION TO SYNTEC-TAICHUN NON-STERILE BONE PLATE AND SCREW IMPLANTS

K090839 is an FDA 510(k) clearance for MODIFICATION TO SYNTEC-TAICHUN NON-STER..., manufactured by Syntec Scientific Corp.. The device is a Class 2 Orthopedic device with product code HRS cleared through the Special 510(k) pathway after a 28-day FDA review.

K090839 · Syntec Scientific Corp. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2009
Decision
28d
Days
Class 2
Risk

K090839 is an FDA 510(k) clearance for the MODIFICATION TO SYNTEC-TAICHUN NON-STERILE BONE PLATE AND SCREW IMPLANTS. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Syntec Scientific Corp. (Taipei City, TW). The FDA issued a Cleared decision on April 24, 2009 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - 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 - K090839

510(k) Number K090839 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 27, 2009
Decision Date April 24, 2009
Days to Decision 28 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
94d faster than avg
Panel avg: 122d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

HRS Device Classification - Class 2, Special Controls

Product Code HRS Plate, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
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 - HRS Plate, Fixation, Bone

All 1314
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K090839.
HINGE PEDIATRIC PLATING SYSTEM
K090440 · Pega Medical, Inc. · May 2009
ORTHOLOC 2.0/2.4 PLATE SYSTEM
K090692 · Wrightmedicaltechnologyinc · May 2009
PEDIPLATES
K090666 · OrthoPediatrics Corp. · Apr 2009
APTUS 2.0 RADIAL HEAD SYSTEM
K090053 · Medartis AG · Apr 2009
SYNTHES (USA) 1.5MM MINI FRAGMENT LCP SYSTEM
K090047 · Synthes (Usa) · Apr 2009
1.5MM SMALL LOCKING PLATE, 1.5MM NON-LOCKING AND LOCKING SCREWS
K090492 · DePuy Orthopaedics, Inc. · Mar 2009
K090839 · MODIFICATION TO SYNTEC-TAICHUN NON-STERILE BONE PLATE AND SCREW IMPLANTS
Download PDF FDA Summary Syntec Scientific Cor…