Cleared Traditional

K931733 - INTERMEDICS ORTHOPEDICS REAMERS (FDA 510(k) Clearance)

Class I Orthopedic device.

K931733 · Intermedics Orthopedics · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1994
Decision
294d
Days
Class 1
Risk

K931733 is an FDA 510(k) clearance for the INTERMEDICS ORTHOPEDICS REAMERS. Classified as File (product code HTP), Class I - General Controls.

Submitted by Intermedics Orthopedics (Austin, US). The FDA issued a Cleared decision on January 26, 1994 after a review of 294 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.4540 - 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. Standard predicate reliance. 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 Intermedics Orthopedics devices

Submission Details

510(k) Number K931733 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 1993
Decision Date January 26, 1994
Days to Decision 294 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
172d slower than avg
Panel avg: 122d · This submission: 294d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HTP File
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 888.4540
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.