Cleared Traditional

K924698 - AXIOM TOTAL KNEE SYSTEM

K924698 is an FDA 510(k) clearance for AXIOM TOTAL KNEE SYSTEM, 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 405-day FDA review.

K924698 · Orthomet, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1993
Decision
405d
Days
Class 2
Risk

K924698 is an FDA 510(k) clearance for the AXIOM TOTAL KNEE SYSTEM, MODULAR TIBIAL TRAY. 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 27, 1993 after a review of 405 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 Orthomet, Inc. devices

FDA 510(k) Submission Details - K924698

510(k) Number K924698 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 1992
Decision Date October 27, 1993
Days to Decision 405 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
283d slower than avg
Panel avg: 122d · This submission: 405d
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 K924698.
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ORTHOLOC ADVANTIM TIBIAL STEM 5 DEGREE
K930228 · Dow Corning Wright · Nov 1993
MG II POROUS KNEE SYSTEM FEMORAL COMPONENTS
K930831 · Zimmer, Inc. · Nov 1993
AXIOM TOTAL KNEE SYST, DUAL DOME ALL POLY TIB TRAY
K930595 · Orthomet, Inc. · Oct 1993
BIOPRO MODULAR TIBIAL TRAY
K922841 · Biopro, Inc. · Sep 1993
THE NATURAL-KNEE REVISION
K930554 · Intermedics Orthopedics · Sep 1993