Cleared Traditional

K841334 - RICHARDS FIXATOR SYSTEM

K841334 is an FDA 510(k) clearance for RICHARDS FIXATOR SYSTEM, manufactured by Richards Medical Co., Inc.. The device is a Class 2 Orthopedic device with product code JEC cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K841334 · Richards Medical Co., Inc. · Orthopedic device
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May 1984
Decision
44d
Days
Class 2
Risk

K841334 is an FDA 510(k) clearance for the RICHARDS FIXATOR SYSTEM. Classified as Component, Traction, Invasive (product code JEC), Class II - Special Controls.

Submitted by Richards Medical Co., Inc. (Mchenry, US). The FDA issued a Cleared decision on May 16, 1984 after a review of 44 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Richards Medical Co., Inc. devices

FDA 510(k) Submission Details - K841334

510(k) Number K841334 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 1984
Decision Date May 16, 1984
Days to Decision 44 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
78d faster than avg
Panel avg: 122d · This submission: 44d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JEC Device Classification - Class 2, Special Controls

Product Code JEC Component, Traction, Invasive
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 - JEC Component, Traction, Invasive

All 46
Devices cleared under the same product code (JEC) and FDA review panel - the closest regulatory comparables to K841334.
KIRSCHNER SUPER-FIXATION SYSTEM
K881896 · Kirschner Medical Corp. · Jul 1988
EXTERNAL FIXATION SYSTEM(CAT. # SERIAS 5129)
K852397 · Howmedica Corp. · Aug 1985
SABA-COOMBS MINI EXTERNAL FIXATOR
K842343 · Zimmer, Inc. · Sep 1984
OXFORD MARK 2 EXTERNAL FIXATOR
K833114 · Johnson & Johnson Professionals, Inc. · Oct 1983
ORTHOFIX
K831576 · Electro-Biology, Inc. · Jun 1983
COLLES FRACTURE FRAME
K830154 · Richard'S Medical Equip., Inc. · Feb 1983