Cleared Traditional

K933570 - RESOLUTION(TM) HIP STEM

K933570 is an FDA 510(k) clearance for RESOLUTION(TM) HIP STEM, manufactured by Wrightmedicaltechnologyinc. The device is a Class 1 Ear, Nose, Throat device with product code LJW cleared through the Traditional 510(k) pathway after a 227-day FDA review.

K933570 · Wrightmedicaltechnologyinc · Ear, Nose, Throat device
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Mar 1994
Decision
227d
Days
Class 1
Risk

K933570 is an FDA 510(k) clearance for the RESOLUTION(TM) HIP STEM. Classified as Tracheotome (product code LJW), Class I - General Controls.

Submitted by Wrightmedicaltechnologyinc (Arlington, US). The FDA issued a Cleared decision on March 7, 1994 after a review of 227 days - an extended review cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.4420 - the FDA ear, nose and throat device 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 Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

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FDA 510(k) Submission Details - K933570

510(k) Number K933570 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received July 23, 1993
Decision Date March 07, 1994
Days to Decision 227 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
137d slower than avg
Panel avg: 90d · This submission: 227d
Pathway characteristics
Predicate-based equivalence.

LJW Device Classification - Class 1, General Controls

Product Code LJW Tracheotome
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.4420
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.