Cleared Traditional

K926257 - ORTHOLOC ADVANTIM THICK TIBIAL BASE COM...

K926257 is an FDA 510(k) clearance for ORTHOLOC ADVANTIM THICK TIBIAL BASE COM..., 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 151-day FDA review.

K926257 · Dow Corning Wright · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1993
Decision
151d
Days
Class 2
Risk

K926257 is an FDA 510(k) clearance for the ORTHOLOC ADVANTIM THICK TIBIAL BASE 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 May 18, 1993 after a review of 151 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 - K926257

510(k) Number K926257 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 1992
Decision Date May 18, 1993
Days to Decision 151 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
29d slower than avg
Panel avg: 122d · This submission: 151d
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 K926257.
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
WHITESIDE ORTHOLOC(R) MODULAR REVISION FEMOR COMP
K915525 · Dow Corning Wright · May 1993
NATURAL-KNEE ALL-POLY TIBIA
K923443 · Intermedics Orthopedics · Mar 1993
KINEMAX(R) CONDYLAR TOTAL KNEE SYST FEMORAL SPACER
K925901 · Howmedica Corp. · Mar 1993