Cleared Traditional

K941755 - ORTHOLOC ADVANTIM LSI POSTERIOR STABLIZ...

K941755 is the FDA 510(k) clearance for ORTHOLOC ADVANTIM LSI POSTERIOR STABLIZ... by Wrightmedicaltechnologyinc. It is a Class 2 Orthopedic device (product code JWH) cleared through the Traditional 510(k) pathway after a 284-day FDA review.

K941755 · Wrightmedicaltechnologyinc · Orthopedic device
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Jan 1995
Decision
284d
Days
Class 2
Risk

K941755 is an FDA 510(k) clearance for the ORTHOLOC ADVANTIM LSI POSTERIOR STABLIZED ALL POLYTHYLENE TIBIAL COMPONENT. Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by Wrightmedicaltechnologyinc (Arlington, US). The FDA issued a Cleared decision on January 17, 1995 after a review of 284 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 Wrightmedicaltechnologyinc devices

Submission Details

510(k) Number K941755 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 1994
Decision Date January 17, 1995
Days to Decision 284 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
162d slower than avg
Panel avg: 122d · This submission: 284d
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 787
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K941755.
DEPUY AMK ALL POLYETHYLENE POSTERIOR STABLILIZED TIBIAL TRAY
K943299 · Depuy, Inc. · Jan 1995
KIRSCHNER PERFORMANCE POSTERIOR STABILIZED TOTAL KNEE SYSTEM
K936274 · Kirschner Medical Corp. · Jan 1995
EXACTECH CEMENTED TOTAL KNEE SYSTEM, TIBIAL COMPONENTS
K933610 · Exactech, Inc. · Jan 1995
RICHARDS TOTAL KNEE SYSTEM
K933958 · Smith & Nephew Richards, Inc. · Jan 1995
DARWIN KNEE SYSTEM
K943462 · Johnson & Johnson Professionals, Inc. · Dec 1994
OSTEONICS SERIES 7000 TOTAL KNEE FEMORAL COMPONENTS
K944285 · Osteonics Corp. · Dec 1994