Cleared Traditional

K833952 - FIXATION PINS

K833952 is an FDA 510(k) clearance for FIXATION PINS, manufactured by Ethicon, Inc.. The device is a Class 2 Orthopedic device with product code HTY cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K833952 · Ethicon, Inc. · Orthopedic device
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Feb 1984
Decision
86d
Days
Class 2
Risk

K833952 is an FDA 510(k) clearance for the FIXATION PINS. Classified as Pin, Fixation, Smooth (product code HTY), Class II - Special Controls.

Submitted by Ethicon, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 10, 1984 after a review of 86 days - a notably fast clearance cycle.

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: 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 Ethicon, Inc. devices

FDA 510(k) Submission Details - K833952

510(k) Number K833952 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 1983
Decision Date February 10, 1984
Days to Decision 86 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
36d faster than avg
Panel avg: 122d · This submission: 86d
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 107
Devices cleared under the same product code (HTY) and FDA review panel - the closest regulatory comparables to K833952.
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
WIRE & STEINMAN PINS
K831005 · Kirschner Medical Corp. · May 1983
PIN RETRACTORS
K771418 · Stryker Corp. · Sep 1977