Cleared Traditional

K960444 - FINN ROD TO ROD CONNECTOR

K960444 is the FDA 510(k) clearance for FINN ROD TO ROD CONNECTOR by Smith & Nephew Richards, Inc.. It is a Class 2 Orthopedic device (product code KWP) cleared through the Traditional 510(k) pathway after a 358-day FDA review.

K960444 · Smith & Nephew Richards, Inc. · Orthopedic device
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Jan 1997
Decision
358d
Days
Class 2
Risk

K960444 is an FDA 510(k) clearance for the FINN ROD TO ROD CONNECTOR. Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by Smith & Nephew Richards, Inc. (Memphis, US). The FDA issued a Cleared decision on January 24, 1997 after a review of 358 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3050 - 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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Smith & Nephew Richards, Inc. devices

Submission Details

510(k) Number K960444 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 1996
Decision Date January 24, 1997
Days to Decision 358 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
236d slower than avg
Panel avg: 122d · This submission: 358d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KWP Appliance, Fixation, Spinal Interlaminal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3050
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 - KWP Appliance, Fixation, Spinal Interlaminal

All 281
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K960444.
MOSS MIAMI SPINAL SYSTEM
K962628 · Depuy, Inc. · Mar 1997
DEPUY MOTECH MOSS MIAMI SPINAL SYSTEM
K965145 · Depuy, Inc. · Mar 1997
TITANIUM CD HORIZON SPINAL SYSTEM
K962708 · Sofamor Danek USA,Inc. · Feb 1997
ALPHA POSTERIOR SPINAL SYSTEM
K964275 · Sofamor Danek USA,Inc. · Jan 1997
HALIFAX PLUS INTERLAMINAR CLAMP SYSTEM
K962314 · Osteonics Corp. · Dec 1996
CD HORIZON SPINAL SYSTEM
K961633 · Sofamor Danek USA,Inc. · Dec 1996