Cleared Traditional

K893040 - ORTHOMET PLUS TOTAL KNEE SYST

K893040 is an FDA 510(k) clearance for ORTHOMET PLUS TOTAL KNEE SYST, manufactured by Orthomet, Inc.. The device is a Class 2 Orthopedic device with product code JWH cleared through the Traditional 510(k) pathway after a 210-day FDA review.

K893040 · Orthomet, Inc. · Orthopedic device
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Nov 1989
Decision
210d
Days
Class 2
Risk

K893040 is an FDA 510(k) clearance for the ORTHOMET PLUS TOTAL KNEE SYST, TITANIUM TIBIAL PEG. 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 November 20, 1989 after a review of 210 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 Orthomet, Inc. devices

FDA 510(k) Submission Details - K893040

510(k) Number K893040 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 1989
Decision Date November 20, 1989
Days to Decision 210 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
88d slower than avg
Panel avg: 122d · This submission: 210d
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 800
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K893040.
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
KINEMAX TIBIAL STEM EXTENSION
K896452 · Howmedica Corp. · Jan 1990
KINEMAX TOTAL KNEE SYSTEM FEMORAL SPACERS
K894658 · Howmedica Corp. · Oct 1989
WHITESIDE ORTHOLOC M.A. TIBIAL BASE
K894504 · Dow Corning Wright · Oct 1989
SECOND GENERATION KNEE SYSTEM
K894334 · Orthomet, Inc. · Oct 1989