Cleared Traditional

K863119 - CANNULATED LAG SCREWS

K863119 is an FDA 510(k) clearance for CANNULATED LAG SCREWS, manufactured by Downs Surgical , Ltd.. The device is a Class 2 Orthopedic device with product code HTY cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K863119 · Downs Surgical , Ltd. · Orthopedic device
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Sep 1986
Decision
20d
Days
Class 2
Risk

K863119 is an FDA 510(k) clearance for the CANNULATED LAG SCREWS. Classified as Pin, Fixation, Smooth (product code HTY), Class II - Special Controls.

Submitted by Downs Surgical , Ltd. (Sheffield S9 4wj, GB). The FDA issued a Cleared decision on September 3, 1986 after a review of 20 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 Downs Surgical , Ltd. devices

FDA 510(k) Submission Details - K863119

510(k) Number K863119 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 1986
Decision Date September 03, 1986
Days to Decision 20 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
102d faster than avg
Panel avg: 122d · This submission: 20d
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 102
Devices cleared under the same product code (HTY) and FDA review panel - the closest regulatory comparables to K863119.
ORTHOMET PIN SYSTEM
K874913 · Orthomet, Inc. · Jan 1988
PDS (POLYDIOXANON) ABSORBABLE PIN
K864912 · Johnson & Johnson Professionals, Inc. · Jul 1987
STEINMANN(THREADED/CALIBRATED),KNOWLES&HOGIE PINS
K863734 · Micro-Aire Surgical Instruments, Inc. · Oct 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, BONEM, RUSH, 1 THRU 10 INCHES LONG
K852561 · The Huxley Instrument Corp. · Jun 1985