Cleared Traditional

K932911 - ORTHOLOC ADVANTIM L.S. TIBIAL COMPONENT

K932911 is an FDA 510(k) clearance for ORTHOLOC ADVANTIM L.S. TIBIAL 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 379-day FDA review.

K932911 · Dow Corning Wright · Orthopedic device
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Jun 1994
Decision
379d
Days
Class 2
Risk

K932911 is an FDA 510(k) clearance for the ORTHOLOC ADVANTIM L.S. TIBIAL 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 June 30, 1994 after a review of 379 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

FDA 510(k) Submission Details - K932911

510(k) Number K932911 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received June 16, 1993
Decision Date June 30, 1994
Days to Decision 379 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
257d slower than avg
Panel avg: 122d · This submission: 379d
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 K932911.
FOUNDATION MODULAR TIBIAL BASEPLATE
K932425 · Encore Orthopedics, Inc. · Jul 1994
NATURAL-KNEE CONGRUENT TIBIAL INSERT WITH SCREW
K931651 · Intermedics Orthopedics · Jul 1994
KIRSCHNER PERFORMANCE TOTAL KNEE SYSTEM POROUS COATED
K934589 · Kirschner Medical Corp. · Jul 1994
LACEY ALL POLYETHYLENE TIBIAL COMPONENT
K934354 · Dow Corning Wright · Jun 1994
HOWMEDICAL TOTAL KNEE STEM EXTENDER
K924482 · Howmedica Corp. · Feb 1994
DURACON CRUCIFORM TIBIAL BASEPLATE
K926228 · Howmedica Corp. · Feb 1994