Cleared Traditional

K941285 - ARTHREX GRAFT HARVESTING KIT

K941285 is an FDA 510(k) clearance for ARTHREX GRAFT HARVESTING KIT, manufactured by Arthrex, Inc.. The device is a Class 1 Orthopedic device with product code KIJ cleared through the Traditional 510(k) pathway after a 242-day FDA review.

K941285 · Arthrex, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1994
Decision
242d
Days
Class 1
Risk

K941285 is an FDA 510(k) clearance for the ARTHREX GRAFT HARVESTING KIT. Classified as Instrument, Surgical, Orthopedic, Dc-powered Motor And Accessory/attachment (product code KIJ), Class I - General Controls.

Submitted by Arthrex, Inc. (Naples, US). The FDA issued a Cleared decision on November 14, 1994 after a review of 242 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Arthrex, Inc. devices

FDA 510(k) Submission Details - K941285

510(k) Number K941285 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 1994
Decision Date November 14, 1994
Days to Decision 242 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
120d slower than avg
Panel avg: 122d · This submission: 242d
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 16
Devices cleared under the same product code (KIJ) and FDA review panel - the closest regulatory comparables to K941285.
STRYKER SYSTEM 4000 HEAVY DUTY BATTERY POWERED EQUIPMENT
K972367 · Stryker Instruments · Sep 1997
STRYKER 2115 REPLACEMENT BATTERY (2115)
K970378 · Implant Resource, Inc. · Apr 1997
ACUMED BONE GRAFT SYSTEM
K960711 · Acu Med, Inc. · May 1996
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