Cleared Traditional

K934354 - LACEY ALL POLYETHYLENE TIBIAL COMPONENT

K934354 is an FDA 510(k) clearance for LACEY ALL POLYETHYLENE 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 269-day FDA review.

K934354 · Dow Corning Wright · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1994
Decision
269d
Days
Class 2
Risk

K934354 is an FDA 510(k) clearance for the LACEY ALL POLYETHYLENE 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 3, 1994 after a review of 269 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 - K934354

510(k) Number K934354 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 1993
Decision Date June 03, 1994
Days to Decision 269 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
147d slower than avg
Panel avg: 122d · This submission: 269d
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 K934354.
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
ORTHOLOC ADVANTIM L.S. TIBIAL COMPONENT
K932911 · Dow Corning Wright · Jun 1994
HOWMEDICAL TOTAL KNEE STEM EXTENDER
K924482 · Howmedica Corp. · Feb 1994
DURACON CRUCIFORM TIBIAL BASEPLATE
K926228 · Howmedica Corp. · Feb 1994
ORTHOLOC ADVANTIM TIBIAL BASE COMPONENT
K932858 · Dow Corning Wright · Feb 1994