Cleared Traditional

K964163 - TRIMAX NAIL SYSTEM

K964163 is the FDA 510(k) clearance for TRIMAX NAIL SYSTEM by Smith & Nephew Richards, Inc.. It is a Class 2 Orthopedic device (product code HSB) cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K964163 · Smith & Nephew Richards, Inc. · Orthopedic device
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Dec 1996
Decision
71d
Days
Class 2
Risk

K964163 is an FDA 510(k) clearance for the TRIMAX NAIL SYSTEM. Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by Smith & Nephew Richards, Inc. (Memphis, US). The FDA issued a Cleared decision on December 27, 1996 after a review of 71 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3020 - 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 Smith & Nephew Richards, Inc. devices

Submission Details

510(k) Number K964163 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 17, 1996
Decision Date December 27, 1996
Days to Decision 71 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
51d faster than avg
Panel avg: 122d · This submission: 71d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HSB Rod, Fixation, Intramedullary And Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3020
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 - HSB Rod, Fixation, Intramedullary And Accessories

All 338
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K964163.
BTI DISTAL FEMORAL INTRAMEDULLARY ROD SYSTEM
K970897 · Biodynamic Technologies, Inc. · Apr 1997
TRUE/FIT FEMORAL INTRAMEDULLARY ROD SYSTEM
K961360 · Encore Orthopedics, Inc. · Mar 1997
INTRAMEDULLARY NAIL SYSTEM
K965098 · Zimmer, Inc. · Feb 1997
TBD
K963026 · Acu Med, Inc. · Oct 1996
TBD
K963077 · Acu Med, Inc. · Oct 1996
EZ-6 PROXIMAL HUMERAL INTERAMEDULLARY ROD SYSTEM
K962552 · Biodynamic Technologies, Inc. · Sep 1996