Cleared Traditional

K790238 - TRANSVERSE TRACTION ASSEMBLY

K790238 is an FDA 510(k) clearance for TRANSVERSE TRACTION ASSEMBLY, manufactured by Zimmer, Inc.. The device is a Class 2 Orthopedic device with product code KWP cleared through the Traditional 510(k) pathway after a 11-day FDA review.

K790238 · Zimmer, Inc. · Orthopedic device
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Feb 1979
Decision
11d
Days
Class 2
Risk

K790238 is an FDA 510(k) clearance for the TRANSVERSE TRACTION ASSEMBLY. Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by Zimmer, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 12, 1979 after a review of 11 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3050 - 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 - K790238

510(k) Number K790238 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 1979
Decision Date February 12, 1979
Days to Decision 11 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
111d faster than avg
Panel avg: 122d · This submission: 11d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KWP Device Classification - Class 2, Special Controls

Product Code KWP Appliance, Fixation, Spinal Interlaminal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3050
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 - KWP Appliance, Fixation, Spinal Interlaminal

All 282
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K790238.
DUNN ANTERIOR DISTRACTION SYSTEM
K801120 · Zimmer, Inc. · May 1980
SANTA CASA DISTRACTOR
K791009 · Depuy, Inc. · Jun 1979
KNEE COMPRESSION HOOK SYSTEM
K790465 · Zimmer, Inc. · Apr 1979
HARRINGTON SPINE INSTRUMENTATION
K781443 · Orthopedic Equipment Co., Inc. · Sep 1978
OUTRIGGER DISTRACTION UNIT
K781444 · Orthopedic Equipment Co., Inc. · Sep 1978