Cleared Traditional

K790262 - UNIVERSAL EXTERNAL FIXATION ASSEMBLY

K790262 is an FDA 510(k) clearance for UNIVERSAL EXTERNAL FIXATION ASSEMBLY, 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 7-day FDA review.

K790262 · Zimmer, Inc. · Orthopedic device
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Feb 1979
Decision
7d
Days
Class 2
Risk

K790262 is an FDA 510(k) clearance for the UNIVERSAL EXTERNAL FIXATION ASSEMBLY. 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 February 13, 1979 after a review of 7 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 - K790262

510(k) Number K790262 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 1979
Decision Date February 13, 1979
Days to Decision 7 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
115d faster than avg
Panel avg: 122d · This submission: 7d
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.