Cleared Traditional

K842493 - AGEE EXTERNAL FIXATOR

K842493 is an FDA 510(k) clearance for AGEE EXTERNAL FIXATOR, manufactured by The Hand Biomechanics Research Laboratory. The device is a Class 2 Orthopedic device with product code JEC cleared through the Traditional 510(k) pathway after a 232-day FDA review.

K842493 · The Hand Biomechanics Research Laboratory · Orthopedic device
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Feb 1985
Decision
232d
Days
Class 2
Risk

K842493 is an FDA 510(k) clearance for the AGEE EXTERNAL FIXATOR. Classified as Component, Traction, Invasive (product code JEC), Class II - Special Controls.

Submitted by The Hand Biomechanics Research Laboratory (Mchenry, US). The FDA issued a Cleared decision on February 13, 1985 after a review of 232 days - an extended review 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: 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.

FDA 510(k) Submission Details - K842493

510(k) Number K842493 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 1984
Decision Date February 13, 1985
Days to Decision 232 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
110d slower than avg
Panel avg: 122d · This submission: 232d
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 71
Devices cleared under the same product code (JEC) and FDA review panel - the closest regulatory comparables to K842493.
LIMA-LTO. SEM MODULAR EXTERNAL STABLIZER
K880282 · Lima-Lto, Inc. · Feb 1988
VITAPATCH PIN PROTECTION DEVICE FOR PERCUT. PINS
K872538 · Vitaphore Corp. · Jul 1987
EXTERNAL FIXATION SYSTEM(CAT. # SERIAS 5129)
K852397 · Howmedica Corp. · Aug 1985
SABA-COOMBS MINI EXTERNAL FIXATOR
K842343 · Zimmer, Inc. · Sep 1984
RICHARDS FIXATOR SYSTEM
K841334 · Richards Medical Co., Inc. · May 1984
OXFORD MARK 2 EXTERNAL FIXATOR
K833114 · Johnson & Johnson Professionals, Inc. · Oct 1983
K842493 · AGEE EXTERNAL FIXATOR
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