Cleared Traditional

K932425 - FOUNDATION MODULAR TIBIAL BASEPLATE

K932425 is an FDA 510(k) clearance for FOUNDATION MODULAR TIBIAL BASEPLATE, 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 429-day FDA review.

K932425 · Encore Orthopedics, Inc. · Orthopedic device
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Jul 1994
Decision
429d
Days
Class 2
Risk

K932425 is an FDA 510(k) clearance for the FOUNDATION MODULAR TIBIAL BASEPLATE. 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 July 22, 1994 after a review of 429 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 - K932425

510(k) Number K932425 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received May 19, 1993
Decision Date July 22, 1994
Days to Decision 429 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
307d slower than avg
Panel avg: 122d · This submission: 429d
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 K932425.
THICK TIBIAL INSERT
K933289 · Wrightmedicaltechnologyinc · Aug 1994
LINE EXTENSION FOR KIRSCHNER PERFORMANCE TOTAL KNEE SYSTEM, POROUS COATED
K933843 · Kirschner Medical Corp. · Aug 1994
FOUNDATION METAL-BACKED PATELLA
K932246 · Encore Orthopedics, Inc. · Jul 1994
NATURAL-KNEE CONGRUENT TIBIAL INSERT WITH SCREW
K931651 · Intermedics Orthopedics · Jul 1994
KIRSCHNER PERFORMANCE TOTAL KNEE SYSTEM POROUS COATED
K934589 · Kirschner Medical Corp. · Jul 1994
ORTHOLOC ADVANTIM L.S. TIBIAL COMPONENT
K932911 · Dow Corning Wright · Jun 1994