Cleared Traditional

K864375 - TYPE 316L COTTER WIRE (FDA 510(k) Clearance)

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

K864375 · Winn Hirsch & Assoc. · Orthopedic device
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May 1987
Decision
196d
Days
Class 2
Risk

K864375 is an FDA 510(k) clearance for the TYPE 316L COTTER WIRE. Classified as Wire, Surgical (product code LRN), Class II - Special Controls.

Submitted by Winn Hirsch & Assoc. (Plainview, US). The FDA issued a Cleared decision on May 20, 1987 after a review of 196 days - an extended review 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: 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 Winn Hirsch & Assoc. devices

Submission Details

510(k) Number K864375 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received November 05, 1986
Decision Date May 20, 1987
Days to Decision 196 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
74d slower than avg
Panel avg: 122d · This submission: 196d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LRN Wire, Surgical
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.