Cleared Traditional

WHITESIDE ORTHOLOC II METAL BACKED PATELLA (K864627) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K864627 · Dow Corning Wright · Orthopedic device
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Feb 1987
Decision
71d
Days
Class 2
Risk

K864627 is an FDA 510(k) clearance for the WHITESIDE ORTHOLOC II METAL BACKED PATELLA. 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 February 4, 1987 after a review of 71 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

Submission Details

510(k) Number K864627 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received November 25, 1986
Decision Date February 04, 1987
Days to Decision 71 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
51d faster than avg
Panel avg: 122d · This submission: 71d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 522
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K864627.
OMNIFIT(R) TOTAL KNEE SYSTEM (MODIFICATION)
K871769 · Osteonics Corp. · Jun 1987
P.C.A. MODULAR KNEE SYSTEM
K864632 · Howmedica Corp. · Mar 1987
ANATOMIC MODULAR KNEE (AMK) SYSTEM
K864671 · Depuy, Inc. · Feb 1987
OMNIFIT (TM) TOTAL KNEE PROSTHESIS SYSTEM
K863668 · Osteonics Corp. · Dec 1986
MODIFIED SYNATOMIC KNEE PATELLA PROSTHESIS
K863667 · Depuy, Inc. · Dec 1986
MILLER/GALANTE TOTAL KNEE POR COATED PATELLAR DOME
K863805 · Zimmer, Inc. · Dec 1986