Cleared Traditional

K960685 - ORTHODOC PREOPERATIVE PLANNER MODEL 500 (FDA 510(k) Clearance)

Class I Orthopedic device.

K960685 · Integrated Surgical Systems, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1997
Decision
332d
Days
Class 1
Risk

K960685 is an FDA 510(k) clearance for the ORTHODOC PREOPERATIVE PLANNER MODEL 500. Classified as Template (product code HWT), Class I - General Controls.

Submitted by Integrated Surgical Systems, Inc. (Sacramento, US). The FDA issued a Cleared decision on January 17, 1997 after a review of 332 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.4800 - 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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Integrated Surgical Systems, Inc. devices

Submission Details

510(k) Number K960685 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 20, 1996
Decision Date January 17, 1997
Days to Decision 332 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
210d slower than avg
Panel avg: 122d · This submission: 332d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HWT Template
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 888.4800
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.