Cleared Traditional

K883576 - HORIZON ORTHOPEDIC PIN PROTECTOR (FDA 510(k) Clearance)

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K883576 · Horizon Medical, Inc. · Orthopedic device
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Sep 1988
Decision
39d
Days
Class 2
Risk

K883576 is an FDA 510(k) clearance for the HORIZON ORTHOPEDIC PIN PROTECTOR. Classified as Fixation Accessory (product code LYT), Class II - Special Controls.

Submitted by Horizon Medical, Inc. (St. Paul, US). The FDA issued a Cleared decision on September 30, 1988 after a review of 39 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - 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 Horizon Medical, Inc. devices

Submission Details

510(k) Number K883576 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 22, 1988
Decision Date September 30, 1988
Days to Decision 39 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
83d faster than avg
Panel avg: 122d · This submission: 39d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LYT Fixation Accessory
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.