Cleared Traditional

K942359 - BONE PLATE SYSTEM

K942359 is the FDA 510(k) clearance for BONE PLATE SYSTEM by Acu Med, Inc.. It is a Class 2 Orthopedic device (product code HRS) cleared through the Traditional 510(k) pathway after a 331-day FDA review.

K942359 · Acu Med, Inc. · Orthopedic device
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Apr 1995
Decision
331d
Days
Class 2
Risk

K942359 is an FDA 510(k) clearance for the BONE PLATE SYSTEM. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Acu Med, Inc. (Beaverton, US). The FDA issued a Cleared decision on April 13, 1995 after a review of 331 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - 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. Elevated predicate reliance profile. 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 K942359 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 17, 1994
Decision Date April 13, 1995
Days to Decision 331 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
209d slower than avg
Panel avg: 122d · This submission: 331d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HRS Plate, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
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 - HRS Plate, Fixation, Bone

All 899
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K942359.
LUHR TITANIUM ALLOY PAN FIXATION SYSTEM
K945137 · Howmedica Corp. · Jun 1995
LUHR TITANIUM PAN FIXATION SYSTEM
K945139 · Howmedica Corp. · Jun 1995
ORTHOMET ACETABULAR ROOF REINFORCEMENT RING
K944856 · Wrightmedicaltechnologyinc · May 1995
LUHR(R) TITANIUM ALLOY BURR HOLE COVERS
K950105 · Howmedica Corp. · Apr 1995
LUHR(R) TITANIUM BURR HOLE COVERS
K950115 · Howmedica, Inc. · Apr 1995
DISTAL RADIUS FRACTURE FIXATION PLATE SYSTEM
K943853 · Wrightmedicaltechnologyinc · Jan 1995