Cleared Traditional

FOUNDATION KNEE SYSTEM TIBIAL COMPONENT (K970031) - FDA 510(k) Clearance

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

K970031 · Encore Orthopedics, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1997
Decision
89d
Days
Class 2
Risk

K970031 is an FDA 510(k) clearance for the FOUNDATION KNEE SYSTEM TIBIAL COMPONENT. Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by Encore Orthopedics, Inc. (Austin, US). The FDA issued a Cleared decision on April 2, 1997 after a review of 89 days - a notably fast clearance cycle.

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: 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 Encore Orthopedics, Inc. devices

Submission Details

510(k) Number K970031 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 1997
Decision Date April 02, 1997
Days to Decision 89 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
33d faster than avg
Panel avg: 122d · This submission: 89d
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 K970031.
KINEMATIC ALL-POLYETHYLENE PATELLA WITH THREE PEGS
K971550 · Howmedica Corp. · Jul 1997
DURATION STABILIZED UHMWPE KNEE COMPONENTS
K965173 · Howmedica Corp. · Jun 1997
DURACON EXTRA-SMALL STABILIZER TIBIAL INSERT & BASEPLATE
K970758 · Howmedica Corp. · May 1997
KIRSCHNER KNEE MODIFIED
K961021 · Biomet, Inc. · Mar 1997
KINEMAX PLUS TIBIAL SPACERS
K964951 · Howmedica Corp. · Feb 1997
NEXGEN COMPLETE KNEE SOLUTION
K963148 · Zimmer, Inc. · Feb 1997