Cleared Traditional

K912894 - AXIOM TOTAL KNEE SYSTEM

K912894 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 109-day FDA review.

K912894 · Orthomet, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1991
Decision
109d
Days
Class 2
Risk

K912894 is an FDA 510(k) clearance for the AXIOM TOTAL KNEE SYSTEM, A/P CURVED TIBIAL INSERT. 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 18, 1991 after a review of 109 days - within the typical 510(k) review window.

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 - K912894

510(k) Number K912894 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 1991
Decision Date October 18, 1991
Days to Decision 109 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
13d faster than avg
Panel avg: 122d · This submission: 109d
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 K912894.
KIRSCHNER(R) HYBRIDFIT TOTAL KNEE SYSTEM
K913492 · Kirschner Medical Corp. · Dec 1991
AXIOM TOTAL KNEE SYSTEM, ALL POLY TIBIAL TRAY
K914230 · Orthomet, Inc. · Dec 1991
FREEMAN-SAMUELSON MODULAR TOTAL KNEE REPLACEMENT
K911972 · Intermedics Orthopedics · Oct 1991
KINEMAX PLUS TIBIAL INSERT
K913188 · Howmedica Corp. · Oct 1991
NATURAL-KNEE ULTRA CONGRUENT TIBIAL INSERT
K912663 · Intermedics Orthopedics · Sep 1991
ANATOMIC MODULAR KNEE POLYETHYLENE TIBIAL TRAY
K910940 · Depuy, Inc. · Sep 1991