Cleared Traditional

K842343 - SABA-COOMBS MINI EXTERNAL FIXATOR

K842343 is an FDA 510(k) clearance for SABA-COOMBS MINI EXTERNAL FIXATOR, manufactured by Zimmer, Inc.. The device is a Class 2 Orthopedic device with product code JEC cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K842343 · Zimmer, Inc. · Orthopedic device
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Sep 1984
Decision
89d
Days
Class 2
Risk

K842343 is an FDA 510(k) clearance for the SABA-COOMBS MINI EXTERNAL FIXATOR. Classified as Component, Traction, Invasive (product code JEC), Class II - Special Controls.

Submitted by Zimmer, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 11, 1984 after a review of 89 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 Zimmer, Inc. devices

FDA 510(k) Submission Details - K842343

510(k) Number K842343 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 1984
Decision Date September 11, 1984
Days to Decision 89 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
33d faster than avg
Panel avg: 122d · This submission: 89d
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 45
Devices cleared under the same product code (JEC) and FDA review panel - the closest regulatory comparables to K842343.
ACE WIRE TENSION CLAMP
K894982 · Buckman Co., Inc. · Jan 1990
KIRSCHNER SUPER-FIXATION SYSTEM
K881896 · Kirschner Medical Corp. · Jul 1988
EXTERNAL FIXATION SYSTEM(CAT. # SERIAS 5129)
K852397 · Howmedica Corp. · Aug 1985
RICHARDS FIXATOR SYSTEM
K841334 · Richards Medical Co., Inc. · May 1984
OXFORD MARK 2 EXTERNAL FIXATOR
K833114 · Johnson & Johnson Professionals, Inc. · Oct 1983
ORTHOFIX
K831576 · Electro-Biology, Inc. · Jun 1983