Cleared Traditional

K932029 - TSRH SPINAL SCREWS (FDA 510(k) Clearance)

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

K932029 · Sofamor Danek Mfg., Inc. · Orthopedic device
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Jan 1995
Decision
633d
Days
Class 2
Risk

K932029 is an FDA 510(k) clearance for the TSRH SPINAL SCREWS. Classified as Orthosis, Spondylolisthesis Spinal Fixation (product code MNH), Class II - Special Controls.

Submitted by Sofamor Danek Mfg., Inc. (Memphis, US). The FDA issued a Cleared decision on January 20, 1995 after a review of 633 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3070 - 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 Sofamor Danek Mfg., Inc. devices

Submission Details

510(k) Number K932029 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 1993
Decision Date January 20, 1995
Days to Decision 633 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
511d slower than avg
Panel avg: 122d · This submission: 633d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MNH Orthosis, Spondylolisthesis Spinal Fixation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3070
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.