Cleared Traditional

K894959 - CYPRESS CERVICAL TRACTION EQUIPMENT, CYPRESS HALO (FDA 510(k) Clearance)

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K894959 · Alphatec Mfg., Inc. · Orthopedic device
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Sep 1990
Decision
403d
Days
Class 2
Risk

K894959 is an FDA 510(k) clearance for the CYPRESS CERVICAL TRACTION EQUIPMENT, CYPRESS HALO. Classified as Component, Traction, Invasive (product code JEC), Class II - Special Controls.

Submitted by Alphatec Mfg., Inc. (Palm Desert, US). The FDA issued a Cleared decision on September 14, 1990 after a review of 403 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Orthopedic submissions.

View all Alphatec Mfg., Inc. devices

Submission Details

510(k) Number K894959 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 1989
Decision Date September 14, 1990
Days to Decision 403 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
281d slower than avg
Panel avg: 122d · This submission: 403d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.