Cleared Traditional

K945500 - WELLS JOHNSON FIXATION SYSTEM

K945500 is an FDA 510(k) clearance for WELLS JOHNSON FIXATION SYSTEM, manufactured by Wells Johnson Co.. The device is a Class 2 Orthopedic device with product code JEY cleared through the Traditional 510(k) pathway after a 316-day FDA review.

K945500 · Wells Johnson Co. · Orthopedic device
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Sep 1995
Decision
316d
Days
Class 2
Risk

K945500 is an FDA 510(k) clearance for the WELLS JOHNSON FIXATION SYSTEM. Classified as Plate, Bone (product code JEY), Class II - Special Controls.

Submitted by Wells Johnson Co. (Tucson, US). The FDA issued a Cleared decision on September 21, 1995 after a review of 316 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 872.4760 - 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 Wells Johnson Co. devices

FDA 510(k) Submission Details - K945500

510(k) Number K945500 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 1994
Decision Date September 21, 1995
Days to Decision 316 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
194d slower than avg
Panel avg: 122d · This submission: 316d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JEY Device Classification - Class 2, Special Controls

Product Code JEY Plate, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.4760
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 - JEY Plate, Bone

All 166
Devices cleared under the same product code (JEY) and FDA review panel - the closest regulatory comparables to K945500.
SYNTHES (USA) MIDFACIAL SYSTEM
K953806 · Synthes (Usa) · Mar 1996
SYNTHES MANDIBULAR MODULAR FIXATION SYSTEM
K954385 · Synthes (Usa) · Mar 1996
LORENZ 1.0MM, 1.5MM, 2.0MM SYSTEM
K953385 · Walter Lorenz Surgical, Inc. · Sep 1995
9I ORAL/MAXILLOFACIAL BONE FIXATION SYSTEM: BONE MESH-PLATE & SCREWS
K953386 · Implant Innovations, Inc. · Sep 1995
3I ORAL/MAXILLOFACIAL BONE FIXATION SYSTEM: STAINLESS STEEL BONE-MESH/PLATE & SCREWS
K952811 · Implant Innovations, Inc. · Aug 1995
3I ORAL/MAXILLOFACIAL BONE FIXATION SYSTEM: COCRMO ALLOY (VITALIUM) BONE-MESH/PLATE & SCREWS
K952812 · Implant Innovations, Inc. · Aug 1995