Cleared Traditional

K861766 - HOWMEDICA HOFFMANN FIXATION PIN SYSTEM

K861766 is the FDA 510(k) clearance for HOWMEDICA HOFFMANN FIXATION PIN SYSTEM by Howmedica Corp.. It is a Class 2 Orthopedic device (product code JDW) cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K861766 · Howmedica Corp. · Orthopedic device
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Jul 1986
Decision
62d
Days
Class 2
Risk

K861766 is an FDA 510(k) clearance for the HOWMEDICA HOFFMANN FIXATION PIN SYSTEM. Classified as Pin, Fixation, Threaded (product code JDW), Class II - Special Controls.

Submitted by Howmedica Corp. (Rutherford, US). The FDA issued a Cleared decision on July 8, 1986 after a review of 62 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 Howmedica Corp. devices

Submission Details

510(k) Number K861766 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 1986
Decision Date July 08, 1986
Days to Decision 62 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
60d faster than avg
Panel avg: 122d · This submission: 62d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JDW Pin, Fixation, Threaded
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 - JDW Pin, Fixation, Threaded

All 52
Devices cleared under the same product code (JDW) and FDA review panel - the closest regulatory comparables to K861766.
ACE PERCUTANEOUS 3MM HALF-PINS
K875013 · Buckman Co., Inc. · Jan 1988
ACE/FISHER PERCUTANEOUS TRANSFIXING PINS
K875022 · Buckman Co., Inc. · Jan 1988
ACE AND ACE/FISCHER PRE-DRILL PIN SYSTEM
K875021 · Buckman Co., Inc. · Dec 1987
BROOKER EXTERNAL FIXATION FRAME
K840286 · Depuy, Inc. · Feb 1984
GOUFFON PIN, ADJUSTABLE
K760454 · Howmedica Corp. · Aug 1976