Cleared Traditional

K852561 - PIN SET

K852561 is an FDA 510(k) clearance for PIN SET, manufactured by The Huxley Instrument Corp.. The device is a Class 2 Orthopedic device with product code HTY cleared through the Traditional 510(k) pathway after a 11-day FDA review.

K852561 · The Huxley Instrument Corp. · Orthopedic device
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Jun 1985
Decision
11d
Days
Class 2
Risk

K852561 is an FDA 510(k) clearance for the PIN SET, BONEM, RUSH, 1 THRU 10 INCHES LONG. Classified as Pin, Fixation, Smooth (product code HTY), Class II - Special Controls.

Submitted by The Huxley Instrument Corp. (Penn Yan, US). The FDA issued a Cleared decision on June 28, 1985 after a review of 11 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 The Huxley Instrument Corp. devices

FDA 510(k) Submission Details - K852561

510(k) Number K852561 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 1985
Decision Date June 28, 1985
Days to Decision 11 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
111d faster than avg
Panel avg: 122d · This submission: 11d
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 K852561.
CANNULATED LAG SCREWS
K863119 · Downs Surgical , Ltd. · Sep 1986
ACE UNILATERAL FIXATOR
K860590 · Buckman Co., Inc. · Mar 1986
PINSET, BONE, RUSH 9-1/2 THRU 20-3/4 INCHES LONG
K852560 · 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