Cleared Traditional

K952330 - EXTERNAL FIXATOR

K952330 is an FDA 510(k) clearance for EXTERNAL FIXATOR, manufactured by Acu Med, Inc.. The device is a Class 2 Orthopedic device with product code JEC cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K952330 · Acu Med, Inc. · Orthopedic device
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Oct 1995
Decision
140d
Days
Class 2
Risk

K952330 is an FDA 510(k) clearance for the EXTERNAL FIXATOR. Classified as Component, Traction, Invasive (product code JEC), Class II - Special Controls.

Submitted by Acu Med, Inc. (Beaverton, US). The FDA issued a Cleared decision on October 5, 1995 after a review of 140 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - 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 Acu Med, Inc. devices

FDA 510(k) Submission Details - K952330

510(k) Number K952330 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 1995
Decision Date October 05, 1995
Days to Decision 140 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
18d slower than avg
Panel avg: 122d · This submission: 140d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JEC Device Classification - Class 2, Special Controls

Product Code JEC Component, Traction, Invasive
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
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 - JEC Component, Traction, Invasive

All 53
Devices cleared under the same product code (JEC) and FDA review panel - the closest regulatory comparables to K952330.
TITANIUM TUBE TO TUBE CLAMP
K960782 · Synthes (Usa) · May 1996
EZ FIX
K954838 · Biodynamic Technologies, Inc. · Jan 1996
MONOTUBE TUBE-TO-TUBE CLAMP
K954667 · Howmedica Corp. · Jan 1996
HOFFMANN II EXTERNAL FIXATION SYSTEM
K952730 · Howmedica Corp. · Sep 1995
ADDITIONAL ACCESSORIES FOR THE ORTHOFIX SYSTEM
K944092 · Orthofix Srl · Apr 1995
EXTERNAL FIXATOR
K943857 · Acu Med, Inc. · Jan 1995