Cleared Traditional

SYNTEC-TAICHUNG NON-STERILE TITANIUM ALLOY MINI-PLATE (K983988) - FDA 510(k) Clearance

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

K983988 · Syntec Scientific Corp. · Orthopedic device
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Jan 1999
Decision
79d
Days
Class 2
Risk

K983988 is an FDA 510(k) clearance for the SYNTEC-TAICHUNG NON-STERILE TITANIUM ALLOY MINI-PLATE. 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. (Chang Hua, TW). The FDA issued a Cleared decision on January 27, 1999 after a review of 79 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. 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 K983988 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 1998
Decision Date January 27, 1999
Days to Decision 79 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
43d faster than avg
Panel avg: 122d · This submission: 79d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 696
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K983988.
SMITH & NEPHEW BONE PLATE SYSTEM (BONE PLATES, BONE SCREWS AND ACCESSORIES)
K993106 · Smith & Nephew, Inc. · Dec 1999
MODIFIED BMP TROCHANTERIC PLATES
K993510 · Biomet, Inc. · Nov 1999
LACTOSORB HAND SYSTEM
K991763 · Biomet, Inc. · Jul 1999
SYNTHES PROXIMAL TIBIA PLATING SYSTEM
K983787 · Synthes (Usa) · Jan 1999
PEDIATRIC CANNULATED OSTEOTOMY PLATES
K983967 · Biomet, Inc. · Dec 1998
HOFFMANN II MIAMI POST
K983419 · Howmedica Corp. · Nov 1998