Cleared Traditional

SECOND GENERATION KNEE SYSTEM (K894334) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K894334 · Orthomet, Inc. · Orthopedic device
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Oct 1989
Decision
84d
Days
Class 2
Risk

K894334 is an FDA 510(k) clearance for the SECOND GENERATION KNEE SYSTEM. Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by Orthomet, Inc. (Minneapolis, US). The FDA issued a Cleared decision on October 6, 1989 after a review of 84 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 Orthomet, Inc. devices

Submission Details

510(k) Number K894334 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received July 14, 1989
Decision Date October 06, 1989
Days to Decision 84 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 122d · This submission: 84d
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 522
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K894334.
SHAW KNEE MODULAR TIBIAL TRAY-POROUS
K894937 · Johnson & Johnson Professionals, Inc. · Jan 1990
KINEMAX TIBIAL STEM EXTENSION
K896452 · Howmedica Corp. · Jan 1990
KINEMAX TOTAL KNEE SYSTEM FEMORAL SPACERS
K894658 · Howmedica Corp. · Oct 1989
MG II POROUS TOTAL KNEE SYSTEM
K892800 · Zimmer, Inc. · Aug 1989
P.F.C. MODULAR KNEE SYSTEM, TIBIAL TRAY-POROUS
K892394 · Johnson & Johnson Professionals, Inc. · Jul 1989
P.F.C.(TM) MODULAR KNEE SYSTEM
K884796 · Johnson & Johnson Professionals, Inc. · Mar 1989