Cleared Traditional

K944330 - ACUTRAK PLUS FIXATION SYSTEM

K944330 is the FDA 510(k) clearance for ACUTRAK PLUS FIXATION SYSTEM by Acu Med, Inc.. It is a Class 2 Orthopedic device (product code HWC) cleared through the Traditional 510(k) pathway after a 241-day FDA review.

K944330 · Acu Med, Inc. · Orthopedic device
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May 1995
Decision
241d
Days
Class 2
Risk

K944330 is an FDA 510(k) clearance for the ACUTRAK PLUS FIXATION SYSTEM. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Acu Med, Inc. (Beaverton, US). The FDA issued a Cleared decision on May 5, 1995 after a review of 241 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 K944330 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received September 06, 1994
Decision Date May 05, 1995
Days to Decision 241 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
119d slower than avg
Panel avg: 122d · This submission: 241d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HWC Screw, Fixation, Bone
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 - HWC Screw, Fixation, Bone

All 562
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K944330.
SYNTHES 2.7 MM CANNULATED SCREW AND THREADED WASHER
K951304 · Synthes (Usa) · Jun 1995
IMPROVED PASSIVATION METHOD FOR METALLIC ORTHOPAEDIC IMPLANTS
K934590 · Smith & Nephew Richards, Inc. · Jun 1995
LINVATEC STASYS-PES FIXATION DEVICE
K934321 · Linvatec Corp. · May 1995
ARTHREX CANCELLOUS SCREW AND WASHER
K945426 · Arthrex, Inc. · Apr 1995
BONE MULCH SCREW
K941941 · Biomet, Inc. · Feb 1995
6.2 VITALLIUM ALLOY CANCELLOUS BONE SCREW
K944213 · Howmedica Corp. · Dec 1994