Cleared Traditional

CMF-TITANIUM CRANIO-MAXILLO-FACIAL FRACTURE FIXATION (OSTEOSYNTHESIS) SYSTEM (K946165) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K946165 · Elekta Instruments, Inc. · Orthopedic device
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May 1995
Decision
155d
Days
Class 2
Risk

K946165 is an FDA 510(k) clearance for the CMF-TITANIUM CRANIO-MAXILLO-FACIAL FRACTURE FIXATION (OSTEOSYNTHESIS) 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 Elekta Instruments, Inc. (Atlanta, US). The FDA issued a Cleared decision on May 23, 1995 after a review of 155 days - an extended review cycle.

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. 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 Elekta Instruments, Inc. devices

Submission Details

510(k) Number K946165 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 1994
Decision Date May 23, 1995
Days to Decision 155 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
33d slower than avg
Panel avg: 122d · This submission: 155d
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 696
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K946165.
LUHR PAN FIXATION SYSTEM CONDENSED STRAIGHT PLATE, Y PLATES AND 1.5MM BONE SCREW
K951415 · Howmedica Corp. · Jun 1995
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
DISTAL RADIUS FRACTURE FIXATION PLATE SYSTEM
K943853 · Wrightmedicaltechnologyinc · Jan 1995