Cleared Traditional

K973031 - STABILIZER SOFT TISSUE ANCHOR 5MM MODEL TA1005, ANCHOR INSERTER/SUTURE ORGANIZER 5MM AI1005, STABILIZER DRILL 5MM NONSTE (FDA 510(k) Clearance)

Class I Physical Medicine device.

K973031 · R. Thomas Grotz, M.D., Inc. · Physical Medicine device
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Nov 1997
Decision
81d
Days
Class 1
Risk

K973031 is an FDA 510(k) clearance for the STABILIZER SOFT TISSUE ANCHOR 5MM MODEL TA1005, ANCHOR INSERTER/SUTURE ORGANI.... Classified as Orthosis, Truncal/orthosis, Limb (product code MRI), Class I - General Controls.

Submitted by R. Thomas Grotz, M.D., Inc. (San Francisco, US). The FDA issued a Cleared decision on November 3, 1997 after a review of 81 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3490 - the FDA physical medicine device 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 R. Thomas Grotz, M.D., Inc. devices

Submission Details

510(k) Number K973031 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 1997
Decision Date November 03, 1997
Days to Decision 81 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
34d faster than avg
Panel avg: 115d · This submission: 81d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MRI Orthosis, Truncal/orthosis, Limb
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.3490
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.