Cleared Traditional

K974406 - ORTHOPLAN

K974406 is an FDA 510(k) clearance for ORTHOPLAN, manufactured by Ortho-Graphics, Inc.. The device is a Class 1 Orthopedic device with product code HWT cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K974406 · Ortho-Graphics, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1998
Decision
89d
Days
Class 1
Risk

K974406 is an FDA 510(k) clearance for the ORTHOPLAN. Classified as Template (product code HWT), Class I - General Controls.

Submitted by Ortho-Graphics, Inc. (Saltlake, US). The FDA issued a Cleared decision on February 18, 1998 after a review of 89 days - a notably fast clearance cycle.

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: 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 Ortho-Graphics, Inc. devices

FDA 510(k) Submission Details - K974406

510(k) Number K974406 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 1997
Decision Date February 18, 1998
Days to Decision 89 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
33d faster than avg
Panel avg: 122d · This submission: 89d
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

Devices cleared under the same product code (HWT) and FDA review panel - the closest regulatory comparables to K974406.
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
WORRELL PATELLA TEMPLATE
K771710 · Depuy, Inc. · Oct 1977