Cleared Traditional

K884839 - MODIFIED SAW BLADES TO THE SAGITAL SAW

K884839 is an FDA 510(k) clearance for MODIFIED SAW BLADES TO THE SAGITAL SAW, manufactured by Dyonics, Inc.. The device is a Class 1 Orthopedic device with product code KIJ cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K884839 · Dyonics, Inc. · Orthopedic device
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Dec 1988
Decision
16d
Days
Class 1
Risk

K884839 is an FDA 510(k) clearance for the MODIFIED SAW BLADES TO THE SAGITAL SAW. Classified as Instrument, Surgical, Orthopedic, Dc-powered Motor And Accessory/attachment (product code KIJ), Class I - General Controls.

Submitted by Dyonics, Inc. (Andover, US). The FDA issued a Cleared decision on December 7, 1988 after a review of 16 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 878.4820 - 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 Dyonics, Inc. devices

FDA 510(k) Submission Details - K884839

510(k) Number K884839 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 1988
Decision Date December 07, 1988
Days to Decision 16 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
106d faster than avg
Panel avg: 122d · This submission: 16d
Pathway characteristics
Predicate-based equivalence.

KIJ Device Classification - Class 1, General Controls

Product Code KIJ Instrument, Surgical, Orthopedic, Dc-powered Motor And Accessory/attachment
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4820
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - KIJ Instrument, Surgical, Orthopedic, Dc-powered Motor And Accessory/attachment

All 14
Devices cleared under the same product code (KIJ) and FDA review panel - the closest regulatory comparables to K884839.
THE OSTEOMED B POWER SYSTEM AND ACCESSORIES
K933101 · Osteomed Corp. · Nov 1994
R AND D BATTERY REPLACEMENT
K933337 · R & D Batteries, Inc. · Apr 1994
3M MAXI-DRIVER II DBATTERY POWERED SYSTEM
K932307 · 3M Health Care, Ltd. · Jan 1994
LYPHOCHEK IMMUNOASSAY SERUM CONTROL LEVEL I,II,III
K864137 · Bio-Rad · Nov 1986
FLUTED SUCTION MENISCAL CUTTER
K850789 · T. Korossurgical Instruments Corp. · Jun 1985
MICRO-CRAFT OSCILLATING SAW HANDPIECE
K822790 · Xomed, Inc. · Oct 1982