Cleared Traditional

K946165 - CMF-TITANIUM CRANIO-MAXILLO-FACIAL FRACTURE FIXATION (OSTEOSYNTHESIS) SYSTEM

K946165 is an FDA 510(k) clearance for CMF-TITANIUM CRANIO-MAXILLO-FACIAL FRAC..., manufactured by Elekta Instruments, Inc.. The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 155-day FDA review.

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

FDA 510(k) Submission Details - K946165

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.

HRS Device Classification - Class 2, Special Controls

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 1078
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
ACE SUPRACONDYLAR PLATE
K950618 · Ace Medical Co. · May 1995
BONE PLATE SYSTEM
K942359 · Acu Med, Inc. · Apr 1995