Cleared Traditional

K864070 - WHITESIDE ORTHOLOC (TM)

K864070 is an FDA 510(k) clearance for WHITESIDE ORTHOLOC (TM), manufactured by Dow Corning Wright. The device is a Class 2 Orthopedic device with product code HRY cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K864070 · Dow Corning Wright · Orthopedic device
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Jan 1987
Decision
99d
Days
Class 2
Risk

K864070 is an FDA 510(k) clearance for the WHITESIDE ORTHOLOC (TM). Classified as Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer (product code HRY), Class II - Special Controls.

Submitted by Dow Corning Wright (Arlington, US). The FDA issued a Cleared decision on January 27, 1987 after a review of 99 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3530 - 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 - K864070

510(k) Number K864070 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received October 20, 1986
Decision Date January 27, 1987
Days to Decision 99 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
23d faster than avg
Panel avg: 122d · This submission: 99d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HRY Device Classification - Class 2, Special Controls

Product Code HRY Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3530
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 - HRY Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer

All 75
Devices cleared under the same product code (HRY) and FDA review panel - the closest regulatory comparables to K864070.
KINEMAX TIBIAL WEDGE
K884837 · Howmedica Corp. · Feb 1989
KIRSCHNER (R) UNICONDYLAR-II KNEE SYSTEM
K882241 · Kirschner Medical Corp. · Jun 1988
AGC UNICOMPARTMENTAL KNEE PROSTHESIS
K873601 · Biomet, Inc. · Jan 1988
ARIZONA CONDYLAR TIBIAL PLATEAU
K862125 · Depuy, Inc. · Jun 1986
MODIFIED SYNATOMIC VARIABLE FIT TIBIAL PLATEAU
K860133 · Depuy, Inc. · Mar 1986
HOWMEDICA KINEMATIC II TIBIAL WEDGE
K842367 · Howmedica Corp. · Aug 1984