Cleared Traditional

K930595 - AXIOM TOTAL KNEE SYST

K930595 is an FDA 510(k) clearance for AXIOM 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 259-day FDA review.

K930595 · Orthomet, Inc. · Orthopedic device
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Oct 1993
Decision
259d
Days
Class 2
Risk

K930595 is an FDA 510(k) clearance for the AXIOM TOTAL KNEE SYST, DUAL DOME ALL POLY TIB 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 22, 1993 after a review of 259 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 - K930595

510(k) Number K930595 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received February 05, 1993
Decision Date October 22, 1993
Days to Decision 259 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
137d slower than avg
Panel avg: 122d · This submission: 259d
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 K930595.
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 SYSTEM, MODULAR TIBIAL TRAY
K924698 · Orthomet, Inc. · Oct 1993
BIOPRO MODULAR TIBIAL TRAY
K922841 · Biopro, Inc. · Sep 1993
THE NATURAL-KNEE REVISION
K930554 · Intermedics Orthopedics · Sep 1993
ANATOMIC MODULAR KNEE (AMK) POSTERIOR STABILIZED
K933304 · Depuy, Inc. · Aug 1993