Cleared Traditional

SYNTEC-TAICHUNG NON-STERILE SMALL ORTHOPEDIC FIXATION SYSTEM, MODEL 71100, 294-300,400 & 292-730/820 (K984364) - FDA 510(k) Clearance

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

K984364 · Syntec Scientific Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1999
Decision
85d
Days
Class 2
Risk

K984364 is an FDA 510(k) clearance for the SYNTEC-TAICHUNG NON-STERILE SMALL ORTHOPEDIC FIXATION SYSTEM, MODEL 71100, 29.... Classified as Appliance, Fixation, Nail/blade/plate Combination, Multiple Component (product code KTT), Class II - Special Controls.

Submitted by Syntec Scientific Corp. (Chang Hua, TW). The FDA issued a Cleared decision on March 2, 1999 after a review of 85 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 K984364 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 1998
Decision Date March 02, 1999
Days to Decision 85 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
37d faster than avg
Panel avg: 122d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KTT Appliance, Fixation, Nail/blade/plate Combination, Multiple Component
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 - KTT Appliance, Fixation, Nail/blade/plate Combination, Multiple Component

All 175
Devices cleared under the same product code (KTT) and FDA review panel - the closest regulatory comparables to K984364.
SYNTHES LARGE FRAGMENT DYNAMIC COMPRESSION LOCKING (DCL) SYSTEM
K000682 · Synthes (Usa) · May 2000
SMALL FRAGMENT DYNAMIC COMPRESSION LOCKING (DCL) SYSTEM
K000684 · Synthes (Usa) · Apr 2000
SMITH & NEPHEW COMPRESSION HIP SCREW SYSTEM, INTRAMEDULLARY HIP SCREW SYSTEM
K993289 · Smith & Nephew, Inc. · Dec 1999
SYNTHES (USA) ARTICULATING DISTAL RADIUS (ADRF) SYSTEM
K984498 · Synthes (Usa) · Feb 1999
BIOSYMMETRIC PROXIMAL INTERPHALANGEAL JOINT FIXATOR
K980370 · Biomet, Inc. · Apr 1998
SYNTHES CANNULATED ANGLE BLADE PLATE (CABP) SYSTEM
K974537 · Synthes (Usa) · Feb 1998