Cleared Traditional

K954138 - DURACON MONOLITHIC STABILIZER FEMORAL C...

K954138 is the FDA 510(k) clearance for DURACON MONOLITHIC STABILIZER FEMORAL C... by Howmedica Corp.. It is a Class 2 Orthopedic device (product code JWH) cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K954138 · Howmedica Corp. · Orthopedic device
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Nov 1995
Decision
81d
Days
Class 2
Risk

K954138 is an FDA 510(k) clearance for the DURACON MONOLITHIC STABILIZER FEMORAL COMPONENT. Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by Howmedica Corp. (Rutherford, US). The FDA issued a Cleared decision on November 21, 1995 after a review of 81 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 Howmedica Corp. devices

Submission Details

510(k) Number K954138 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received September 01, 1995
Decision Date November 21, 1995
Days to Decision 81 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
41d faster than avg
Panel avg: 122d · This submission: 81d
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 764
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K954138.
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DARWIN KNEE SYSTEM (TC3)
K952830 · Johnson & Johnson Professionals, Inc. · Jan 1996
PCA(R) MODULAR TOTAL KNEE TIB INSERT DUROCON BASEPLATE
K940861 · Howmedica Corp. · Sep 1995
GENESIS CONSTRAINED SYSTEM (GCS)
K952271 · Smith & Nephew Richards, Inc. · Sep 1995
GENESIS II TOTAL KNEE SYSTEM
K951987 · Smith & Nephew Richards, Inc. · Aug 1995