Cleared Traditional

K984498 - SYNTHES (USA) ARTICULATING DISTAL RADIUS (ADRF) SYSTEM

K984498 is an FDA 510(k) clearance for SYNTHES (USA) ARTICULATING DISTAL RADIU..., manufactured by Synthes (Usa). The device is a Class 2 Orthopedic device with product code KTT cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K984498 · Synthes (Usa) · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1999
Decision
63d
Days
Class 2
Risk

K984498 is an FDA 510(k) clearance for the SYNTHES (USA) ARTICULATING DISTAL RADIUS (ADRF) SYSTEM. Classified as Appliance, Fixation, Nail/blade/plate Combination, Multiple Component (product code KTT), Class II - Special Controls.

Submitted by Synthes (Usa) (Paoli, US). The FDA issued a Cleared decision on February 18, 1999 after a review of 63 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 Synthes (Usa) devices

FDA 510(k) Submission Details - K984498

510(k) Number K984498 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 17, 1998
Decision Date February 18, 1999
Days to Decision 63 days
Submission Type Traditional
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
59d faster than avg
Panel avg: 122d · This submission: 63d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KTT Device Classification - Class 2, Special Controls

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 358
Devices cleared under the same product code (KTT) and FDA review panel - the closest regulatory comparables to K984498.
EBI XFIX DFS OPTIROM ELBOW FIXATOR
K992515 · Ebi, L.P. · Aug 1999
VHS SUPRACONDYLAR PLATE SYSTEM
K991806 · Walter Abendschein, M.D. · Aug 1999
SYNTEC-TAICHUNG NON-STERILE SMALL ORTHOPEDIC FIXATION SYSTEM, MODEL 71100, 294-300,400 & 292-730/820
K984364 · Syntec Scientific Corp. · Mar 1999
SYNTEC-TAICHUNG NON-STERILE DHS/DCS PLATE SYSTEM
K983873 · Syntec Scientific Corp. · Dec 1998
EBI DFS JOINT FIXATOR, MODEL 02800
K981483 · Electro-Biology, Inc. · Jul 1998
BIOSYMMETRIC PROXIMAL INTERPHALANGEAL JOINT FIXATOR
K980370 · Biomet, Inc. · Apr 1998