Cleared Traditional

K933539 - FOUNDATION POSTERIOR STABILIZED KNEE

K933539 is an FDA 510(k) clearance for FOUNDATION POSTERIOR STABILIZED KNEE, manufactured by Encore Orthopedics, Inc.. The device is a Class 2 Orthopedic device with product code JWH cleared through the Traditional 510(k) pathway after a 475-day FDA review.

K933539 · Encore Orthopedics, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1994
Decision
475d
Days
Class 2
Risk

K933539 is an FDA 510(k) clearance for the FOUNDATION POSTERIOR STABILIZED KNEE. 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 November 8, 1994 after a review of 475 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 Encore Orthopedics, Inc. devices

FDA 510(k) Submission Details - K933539

510(k) Number K933539 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 1993
Decision Date November 08, 1994
Days to Decision 475 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
353d slower than avg
Panel avg: 122d · This submission: 475d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JWH Device Classification - Class 2, Special Controls

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 787
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K933539.
EXACTECH POROUS COATED POSTERIOR STABILIZED FEMORAL COMPONENT
K935773 · Exactech, Inc. · Dec 1994
OSTEONICS SERIES 7000 BASIC FEMORAL COMPONENTS
K941128 · Osteonics Corp. · Dec 1994
PCA MODULAR PRIMARY/REVISION PATELLA
K940713 · Howmedica Corp. · Nov 1994
CRUCIATE RETAINING CEMENTED TIBIAL COMPONENTS
K932776 · Exactech, Inc. · Oct 1994
EXACTECH POROUS COATED CRUCIATE RETAINED FEMORAL COMPONENT
K935726 · Exactech, Inc. · Oct 1994
AXIOM TOTAL KNEE SYST/ACL RETAIN TIBIAL TRAY/INSER
K926334 · Orthomet, Inc. · Oct 1994