Cleared Traditional

K943857 - EXTERNAL FIXATOR

K943857 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 172-day FDA review.

K943857 · Acu Med, Inc. · Orthopedic device
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Jan 1995
Decision
172d
Days
Class 2
Risk

K943857 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 January 27, 1995 after a review of 172 days - an extended review cycle.

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 K943857 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received August 08, 1994
Decision Date January 27, 1995
Days to Decision 172 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
50d slower than avg
Panel avg: 122d · This submission: 172d
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 K943857.
EXTERNAL FIXATOR
K952330 · Acu Med, Inc. · Oct 1995
HOFFMANN II EXTERNAL FIXATION SYSTEM
K952730 · Howmedica Corp. · Sep 1995
ADDITIONAL ACCESSORIES FOR THE ORTHOFIX SYSTEM
K944092 · Orthofix Srl · Apr 1995
PELVIC C-CLAMP
K922796 · Synthes (Usa) · Mar 1994
HOWMEDICA MONO-TUBE SINGLE PIN CLAMP
K934698 · Howmedica Corp. · Feb 1994
HOWMEDICA MONOTUBE T-CONNECTOR
K936124 · Howmedica, Inc. · Feb 1994