Cleared Traditional

K973031 - STABILIZER SOFT TISSUE ANCHOR 5MM MODEL TA1005, ANCHOR INSERTER/SUTURE ORGANIZER 5MM AI1005, STABILIZER DRILL 5MM NONSTE

K973031 is an FDA 510(k) clearance for STABILIZER SOFT TISSUE ANCHOR 5MM MODEL..., manufactured by R. Thomas Grotz, M.D., Inc.. The device is a Class 1 Physical Medicine device with product code MRI cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K973031 · R. Thomas Grotz, M.D., Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K973031

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
34d faster than avg
Panel avg: 115d · This submission: 81d
Pathway characteristics
Predicate-based equivalence.

MRI Device Classification - Class 1, General Controls

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.