Cleared Traditional

K893639 - GAMMA LOCKING NAIL

K893639 is the FDA 510(k) clearance for GAMMA LOCKING NAIL by Howmedica Corp.. It is a Class 2 Orthopedic device (product code KTT) cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K893639 · Howmedica Corp. · Orthopedic device
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Aug 1989
Decision
83d
Days
Class 2
Risk

K893639 is an FDA 510(k) clearance for the GAMMA LOCKING NAIL. Classified as Appliance, Fixation, Nail/blade/plate Combination, Multiple Component (product code KTT), Class II - Special Controls.

Submitted by Howmedica Corp. (Rutherford, US). The FDA issued a Cleared decision on August 3, 1989 after a review of 83 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - 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 K893639 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 1989
Decision Date August 03, 1989
Days to Decision 83 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
39d faster than avg
Panel avg: 122d · This submission: 83d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KTT Appliance, Fixation, Nail/blade/plate Combination, Multiple Component
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
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 - KTT Appliance, Fixation, Nail/blade/plate Combination, Multiple Component

All 271
Devices cleared under the same product code (KTT) and FDA review panel - the closest regulatory comparables to K893639.
DR. HERZBERG DISPOSABLE EXTERNAL FIXATOR
K890989 · Origin Medsystems, Inc. · Apr 1990
INTRAMEDULLARY HIP SCREW
K895241 · Richards Medical Co., Inc. · Jan 1990
DANEK WRIST FIXATOR
K891066 · Danek Medical, Inc. · Aug 1989
DANEK RING FIXATOR (DRF)
K890814 · Danek Medical, Inc. · Jun 1989
ALTA SYSTEMS TIBIAL/UPPER EXTREMITY DIAPHYSEAL PLT
K873459 · Howmedica Corp. · Oct 1987
MODIFIED TROCHANTER CABLE GRIP SYSTEM
K872224 · Howmedica Corp. · Aug 1987