Cleared Traditional

K850026 - ORTHOPEDIC IMPLANT NAILS & PINS

K850026 is an FDA 510(k) clearance for ORTHOPEDIC IMPLANT NAILS & PINS, manufactured by Kirkstil Corp., Inc.. The device is a Class 2 Orthopedic device with product code HTY cleared through the Traditional 510(k) pathway after a 137-day FDA review.

K850026 · Kirkstil Corp., Inc. · Orthopedic device
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May 1985
Decision
137d
Days
Class 2
Risk

K850026 is an FDA 510(k) clearance for the ORTHOPEDIC IMPLANT NAILS & PINS. Classified as Pin, Fixation, Smooth (product code HTY), Class II - Special Controls.

Submitted by Kirkstil Corp., Inc. (St. Louis, US). The FDA issued a Cleared decision on May 20, 1985 after a review of 137 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - 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.

FDA 510(k) Submission Details - K850026

510(k) Number K850026 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 1985
Decision Date May 20, 1985
Days to Decision 137 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
15d slower than avg
Panel avg: 122d · This submission: 137d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HTY Device Classification - Class 2, Special Controls

Product Code HTY Pin, Fixation, Smooth
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
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.

Regulatory Peers - HTY Pin, Fixation, Smooth

All 204
Devices cleared under the same product code (HTY) and FDA review panel - the closest regulatory comparables to K850026.
PIN SET, BONEM, RUSH, 1 THRU 10 INCHES LONG
K852561 · The Huxley Instrument Corp. · Jun 1985
PIN SET, BONE, RUSH, 4 THRU 10 1/2 INCHES LONG
K852562 · The Huxley Instrument Corp. · Jun 1985
PIN SET, BONE RUSH, 7-1/4 THRU 18-1/2 INCHES LONG
K852563 · The Huxley Instrument Corp. · Jun 1985
FIXATION PINS
K833952 · Ethicon, Inc. · Feb 1984
WIRE & STEINMAN PINS
K831005 · Kirschner Medical Corp. · May 1983
PIN RETRACTORS
K771418 · Stryker Corp. · Sep 1977
K850026 · ORTHOPEDIC IMPLANT NAILS & PINS
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