Cleared Traditional

NATURAL-KNEE TIBIAL BASEPLATE/ALL POLY PATELLA (K934695) - FDA 510(k) Clearance

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

K934695 · Intermedics Orthopedics · Orthopedic device
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May 1996
Decision
945d
Days
Class 2
Risk

K934695 is an FDA 510(k) clearance for the NATURAL-KNEE TIBIAL BASEPLATE/ALL POLY PATELLA. Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by Intermedics Orthopedics (Austin, US). The FDA issued a Cleared decision on May 2, 1996 after a review of 945 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 Intermedics Orthopedics devices

Submission Details

510(k) Number K934695 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 1993
Decision Date May 02, 1996
Days to Decision 945 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
823d slower than avg
Panel avg: 122d · This submission: 945d
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 522
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K934695.
DURACON ALL POLYETHYLENE PATELLA II
K961483 · Howmedica Corp. · Jul 1996
DURACON INSET PATELLA WITH CENTRAL PEG
K961482 · Howmedica Corp. · Jul 1996
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
FREEMAN/SAMUELSON TOTAL KNEE SYSTEM
K943025 · Biomet, Inc. · Mar 1996