Cleared Traditional

K925900 - LACEY REVISION FEMORAL COMPONENT

K925900 is an FDA 510(k) clearance for LACEY REVISION 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 277-day FDA review.

K925900 · Dow Corning Wright · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1993
Decision
277d
Days
Class 2
Risk

K925900 is an FDA 510(k) clearance for the LACEY REVISION 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 24, 1993 after a review of 277 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 - K925900

510(k) Number K925900 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 1992
Decision Date August 24, 1993
Days to Decision 277 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
155d slower than avg
Panel avg: 122d · This submission: 277d
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 K925900.
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
ORTHOLOC(R) ADVANTIM(TM) POSTERIOR STAB FEMOR COMP
K930189 · Dow Corning Wright · Aug 1993
ORTHOLOC(R) ADVANTIM(TM) FEMORAL COMPONENT
K930188 · Dow Corning Wright · Aug 1993
ORTHOLOC(R) ADVANTIM(TM) NON-POR COAT FEMOR COMP
K930190 · Dow Corning Wright · Aug 1993