Cleared Traditional

K871776 - WHITESIDE ORTHOLOC II REV POST STAB TOTAL KNEE SY

K871776 is an FDA 510(k) clearance for WHITESIDE ORTHOLOC II REV POST STAB TOT..., 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 89-day FDA review.

K871776 · Dow Corning Wright · Orthopedic device
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Aug 1987
Decision
89d
Days
Class 2
Risk

K871776 is an FDA 510(k) clearance for the WHITESIDE ORTHOLOC II REV POST STAB TOTAL KNEE SY. 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 3, 1987 after a review of 89 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 - K871776

510(k) Number K871776 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received May 06, 1987
Decision Date August 03, 1987
Days to Decision 89 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
33d faster than avg
Panel avg: 122d · This submission: 89d
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 897
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K871776.
PLUS TOTAL KNEE SYSTEM, POLY PATELLAR BUTTON
K872134 · Orthomet, Inc. · Oct 1987
HOWMEDICA KINEMATIC II MODULAR TIBIAL COMPONENT
K871349 · Howmedica Corp. · Sep 1987
CLARIFIED APPLICA. FOR LACEY CONDYLAR TOTAL KNEE
K872266 · Dow Corning Wright · Aug 1987
GUSTILO/RAND TOTAL KNEE SYSTEM (GENESIS)
K871146 · Richards Medical Co., Inc. · Jul 1987
MODIFIED ANATOMIC MODULAR KNEE (AMK) SYSTEM
K871585 · Depuy, Inc. · Jul 1987
LACEY METAL BACKED PATELLA PROSTHESIS
K870273 · Dow Corning Wright · Jul 1987