Cleared Traditional

SYNTEC-TAICHUNG NON-STERILE BONE PLATE AND SCREW IMPLANTS, MODEL#'S 222020-248120, 240050-240980, 241130-246620, 4240420 (K983495) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K983495 · Syntec Scientific Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1998
Decision
72d
Days
Class 2
Risk

K983495 is an FDA 510(k) clearance for the SYNTEC-TAICHUNG NON-STERILE BONE PLATE AND SCREW IMPLANTS, MODEL#'S 222020-24.... Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Syntec Scientific Corp. (Chang Hua, TW). The FDA issued a Cleared decision on December 16, 1998 after a review of 72 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Syntec Scientific Corp. devices

Submission Details

510(k) Number K983495 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 05, 1998
Decision Date December 16, 1998
Days to Decision 72 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
50d faster than avg
Panel avg: 122d · This submission: 72d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HWC Screw, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
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 - HWC Screw, Fixation, Bone

All 404
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K983495.
BONE MULCH SCREW SYSTEM
K991298 · Biomet, Inc. · May 1999
STAINLESS STEEL TAPER FOREMAN NAIL CANNULATED SCREW, STAINLESS STEEL CANNULATED SCREW, SHORT THREAD, STAINLESS STEEL PED
K984209 · Biomet, Inc. · Feb 1999
BIOABSORBABLE INTERFERENCE SCREWS
K984320 · Smith & Nephew, Inc. · Jan 1999
OSTEO COMPRESSION CONDYLE SCREW SYSTEM
K983508 · Osteonics Corp. · Dec 1998
OSTEO 4.0MM CANNULATED SCREW SYSTEM
K983165 · Osteonics Corp. · Dec 1998
DEPUY PROFILE ROUND HEAD INTERFERENCE SCREW, DEPUY PHANTOM RESORBABLE INTERFERENCE SCREW
K982662 · DePuy Orthopaedics, Inc. · Oct 1998