Cleared Traditional

FREEMAN/SAMUELSON TOTAL KNEE SYSTEM (K943025) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K943025 · Biomet, Inc. · Orthopedic device
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Mar 1996
Decision
625d
Days
Class 2
Risk

K943025 is an FDA 510(k) clearance for the FREEMAN/SAMUELSON TOTAL KNEE SYSTEM. Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on March 13, 1996 after a review of 625 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3560 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Orthopedic submissions.

View all Biomet, Inc. devices

Submission Details

510(k) Number K943025 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received June 27, 1994
Decision Date March 13, 1996
Days to Decision 625 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
503d slower than avg
Panel avg: 122d · This submission: 625d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JWH Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3560
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 - JWH Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer

All 521
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K943025.
DEPUY AMK POROUS COATED CRX TIBIAL TRAY (1988-20/28-000 AND 1988-20/28-501)
K961379 · Depuy, Inc. · Jun 1996
NEXGEN COMPL. KNEE SOL. LEGACY POSTERIOR STABILIZED/CONSTRAINED CONDYLAR KNEE FEMORAL COMPONENTS/ARTICULAR SURFACES
K960279 · Zimmer, Inc. · Apr 1996
NEXGEN COMPLETE KNEE SOLUTION 9MM ARTICULAR SURFACE
K951185 · Zimmer, Inc. · Mar 1996
COORDINATE REVISION KNEE SYSTEM
K955884 · Depuy, Inc. · Mar 1996
OPTETRAK CONSTRAINED CONDYLAR KNEE FOR CEMENTED USE ONLY
K954208 · Exactech, Inc. · Feb 1996
OSTEONICS N2/VAC PACKAGING PROCESS
K955421 · Osteonics Corp. · Feb 1996