Cleared Traditional

K881378 - PFIZER HOSPITAL PRODUCTS GROUP ACL DRILL GUIDE (FDA 510(k) Clearance)

Class I Orthopedic device.

K881378 · Pfizer, Inc. · Orthopedic device
Jun 1988
Decision
77d
Days
Class 1
Risk

K881378 is an FDA 510(k) clearance for the PFIZER HOSPITAL PRODUCTS GROUP ACL DRILL GUIDE. Classified as Guide, Drill, Ligament (product code LXI), Class I - General Controls.

Submitted by Pfizer, Inc. (Groton, US). The FDA issued a Cleared decision on June 17, 1988 after a review of 77 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 878.4820 - 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.

Submission Details

510(k) Number K881378 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 1988
Decision Date June 17, 1988
Days to Decision 77 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 116d · This submission: 77d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LXI Guide, Drill, Ligament
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4820
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.