Cleared Traditional

K960685 - ORTHODOC PREOPERATIVE PLANNER MODEL 500

K960685 is an FDA 510(k) clearance for ORTHODOC PREOPERATIVE PLANNER MODEL 500, manufactured by Integrated Surgical Systems, Inc.. The device is a Class 1 Orthopedic device with product code HWT cleared through the Traditional 510(k) pathway after a 332-day FDA review.

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

FDA 510(k) Submission Details - K960685

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.

HWT Device Classification - Class 1, General Controls

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.

Regulatory Peers - HWT Template

All 7
Devices cleared under the same product code (HWT) and FDA review panel - the closest regulatory comparables to K960685.
ORTHOPLAN
K974406 · Ortho-Graphics, Inc. · Feb 1998
SCHULTZ PHALANGEAL COMP TRIAL/METACARPAL COMP TRIA
K870843 · Warsaw Orthopedic, Inc. · May 1987
ARTHROSCOPIC MENISCAL SUTURE SYSTEM
K871323 · Orthopedic Systems, Inc. · May 1987
3M OSTEOTOMY GUIDE
K830360 · 3M Company · Mar 1983
KNEE INSTRUMENTATION, CONDYLAR
K781091 · Biomet, Inc. · Jul 1978
WORRELL TRIAL PATELLA
K771709 · Depuy, Inc. · Oct 1977