Cleared Traditional

K894403 - PCA MODULAR KNEE CONSTRAINED TIBIAL INSERT

K894403 is an FDA 510(k) clearance for PCA MODULAR KNEE CONSTRAINED TIBIAL INSERT, manufactured by Howmedica Corp.. The device is a Class 2 Orthopedic device with product code JWH cleared through the Traditional 510(k) pathway after a 200-day FDA review.

K894403 · Howmedica Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1990
Decision
200d
Days
Class 2
Risk

K894403 is an FDA 510(k) clearance for the PCA MODULAR KNEE CONSTRAINED TIBIAL INSERT. 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 February 2, 1990 after a review of 200 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Howmedica Corp. devices

FDA 510(k) Submission Details - K894403

510(k) Number K894403 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received July 17, 1989
Decision Date February 02, 1990
Days to Decision 200 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
78d slower than avg
Panel avg: 122d · This submission: 200d
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 885
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K894403.
S-ROM(TM)/NOILES(TM) MARK 5 KNEE
K896397 · Joint Medical Products Corp. · Feb 1990
ADDITION TO THE CONTINUUM KNEE SYSTEM (CKS(TM))
K896542 · Techmedica, Inc. · Feb 1990
MG II POROUS TOTAL KNEE SYSTEM/METAL-BACK PATELLAR
K895639 · Zimmer, Inc. · Feb 1990
SHAW KNEE MODULAR TIBIAL TRAY-POROUS
K894937 · Johnson & Johnson Professionals, Inc. · Jan 1990
KIRSCHNER PERFORMANCE TOTAL KNEE SYSTEM, POROUS
K895962 · Kirschner Medical Corp. · Jan 1990
WHITESIDE ORTHOLOC MODULAR-C TOTAL KNEE SYSTEM
K896045 · Dow Corning Wright · Jan 1990