Cleared Traditional

K901992 - WHITESIDE ORTHOLOC MODULAR POST. STAB. ...

K901992 is an FDA 510(k) clearance for WHITESIDE ORTHOLOC MODULAR POST. STAB. ..., 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 55-day FDA review.

K901992 · Dow Corning Wright · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1990
Decision
55d
Days
Class 2
Risk

K901992 is an FDA 510(k) clearance for the WHITESIDE ORTHOLOC MODULAR POST. STAB. KNEE SYSTEM. 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 26, 1990 after a review of 55 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Dow Corning Wright devices

FDA 510(k) Submission Details - K901992

510(k) Number K901992 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received May 02, 1990
Decision Date June 26, 1990
Days to Decision 55 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
67d faster than avg
Panel avg: 122d · This submission: 55d
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 K901992.
ANATOMIC MODULAR KNEE (AMK) POSTERIOR STABILIZED
K901406 · Depuy, Inc. · Jul 1990
SECOND GENERATION KNEE SYSTEM, FEMORAL, PATELLAR
K895145 · Orthomet, Inc. · Jul 1990
PLUS TOTAL KNEE SYST/PERI POST DESIGN TIBIAL COMP
K901936 · Orthomet, Inc. · Jul 1990
CONTINUUM KNEE SYSTEM (CKS)
K901457 · Techmedica, Inc. · Jun 1990
KIRSCHNER MODULAR TCIV TOTAL KNEE SYSTEM
K901338 · Kirschner Medical Corp. · May 1990
NUFFIELD TOTAL KNEE
K892503 · Orthopedic Systems, Inc. · May 1990