Cleared Traditional

K930188 - ORTHOLOC ADVANTIM(TM) FEMORAL COMPONENT

K930188 is an FDA 510(k) clearance for ORTHOLOC ADVANTIM(TM) FEMORAL COMPONENT, manufactured by Dow Corning Wright. The device is a Class 2 Orthopedic device with product code JWH cleared through the Traditional 510(k) pathway after a 201-day FDA review.

K930188 · Dow Corning Wright · Orthopedic device
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Optimized for regulatory review, auditing and printing
Aug 1993
Decision
201d
Days
Class 2
Risk

K930188 is an FDA 510(k) clearance for the ORTHOLOC(R) ADVANTIM(TM) FEMORAL COMPONENT. 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 August 3, 1993 after a review of 201 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 Dow Corning Wright devices

FDA 510(k) Submission Details - K930188

510(k) Number K930188 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 14, 1993
Decision Date August 03, 1993
Days to Decision 201 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
79d slower than avg
Panel avg: 122d · This submission: 201d
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 787
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K930188.
ANATOMIC MODULAR KNEE (AMK) POSTERIOR STABILIZED
K933304 · Depuy, Inc. · Aug 1993
LACEY REVISION FEMORAL COMPONENT
K925900 · Dow Corning Wright · Aug 1993
ORTHOLOC(R) ADVANTIM(TM) POSTERIOR STAB FEMOR COMP
K930189 · Dow Corning Wright · Aug 1993
ORTHOLOC(R) ADVANTIM(TM) NON-POR COAT FEMOR COMP
K930190 · Dow Corning Wright · Aug 1993
ULTRA HIGH MOLECULAR WEIGHT POLYETHYLENE COMPONENT
K921182 · Biomet, Inc. · Jul 1993
APOLLO(TM) KNEE SYSTEM
K925242 · Intermedics Orthopedics · Jun 1993