Cleared Traditional

K952330 - EXTERNAL FIXATOR

K952330 is the FDA 510(k) clearance for EXTERNAL FIXATOR by Acu Med, Inc.. It is a Class 2 Orthopedic device (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

Submission Details

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.

Device Classification

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 43
Devices cleared under the same product code (JEC) and FDA review panel - the closest regulatory comparables to K952330.
MONOTUBE TUBE TO RING CLAMP
K961618 · Howmedica Corp. · May 1996
TITANIUM TUBE TO TUBE CLAMP
K960782 · Synthes (Usa) · May 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