Cleared Traditional

ORTHOLOC ADVANTIM TIBIAL STEM 5 DEGREE (K930228) - FDA 510(k) Clearance

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

K930228 · Dow Corning Wright · Orthopedic device
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Nov 1993
Decision
315d
Days
Class 2
Risk

K930228 is an FDA 510(k) clearance for the ORTHOLOC ADVANTIM TIBIAL STEM 5 DEGREE. Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by Dow Corning Wright (Arlington, US). The FDA issued a Cleared decision on November 30, 1993 after a review of 315 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: Standard predicate-based submission. Elevated predicate reliance profile. 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 Dow Corning Wright devices

Submission Details

510(k) Number K930228 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 19, 1993
Decision Date November 30, 1993
Days to Decision 315 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
193d slower than avg
Panel avg: 122d · This submission: 315d
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 K930228.
DURACON CRUCIFORM TIBIAL BASEPLATE
K926228 · Howmedica Corp. · Feb 1994
AMK LANDMARK REVISION KNEE SYSTEM
K925072 · Depuy, Inc. · Jan 1994
AMK LANDMARK REVISION KNEE FULL WEDGE TIBIAL TRAY
K925837 · Depuy, Inc. · Jan 1994
MG II POROUS KNEE SYSTEM FEMORAL COMPONENTS
K930831 · Zimmer, Inc. · Nov 1993
ANATOMIC MODULAR KNEE (AMK) POSTERIOR STABILIZED
K933304 · Depuy, Inc. · Aug 1993
ULTRA HIGH MOLECULAR WEIGHT POLYETHYLENE COMPONENT
K921182 · Biomet, Inc. · Jul 1993