Cleared Traditional

K940861 - PCA MODULAR TOTAL KNEE TIB INSERT DUROC...

K940861 is the FDA 510(k) clearance for PCA MODULAR TOTAL KNEE TIB INSERT DUROC... by Howmedica Corp.. It is a Class 2 Orthopedic device (product code JWH) cleared through the Traditional 510(k) pathway after a 572-day FDA review.

K940861 · Howmedica Corp. · Orthopedic device
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Sep 1995
Decision
572d
Days
Class 2
Risk

K940861 is an FDA 510(k) clearance for the PCA(R) MODULAR TOTAL KNEE TIB INSERT DUROCON BASEPLATE. 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 September 18, 1995 after a review of 572 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 Howmedica Corp. devices

Submission Details

510(k) Number K940861 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 1994
Decision Date September 18, 1995
Days to Decision 572 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
450d slower than avg
Panel avg: 122d · This submission: 572d
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 K940861.
DEPUY ANATOMIC MODULAR KNEE (AMK) CONGRUENCY POSTERIOR STABILIZED TIBIAL INSERT
K954684 · Depuy, Inc. · Jan 1996
DARWIN KNEE SYSTEM (TC3)
K952830 · Johnson & Johnson Professionals, Inc. · Jan 1996
DURACON MONOLITHIC STABILIZER FEMORAL COMPONENT
K954138 · Howmedica Corp. · Nov 1995
GENESIS CONSTRAINED SYSTEM (GCS)
K952271 · Smith & Nephew Richards, Inc. · Sep 1995
GENESIS II TOTAL KNEE SYSTEM
K951987 · Smith & Nephew Richards, Inc. · Aug 1995
OSTEONICS SERIES 7000 TOTAL KNEE FULL TIBIAL BONE AUGEMENTATION BLOCKS & WEDGES
K951956 · Osteonics Corp. · Aug 1995