Cleared Traditional

K881779 - WHITESIDE ORTHOLOC II UNICONDYLAR KNEE ...

K881779 is an FDA 510(k) clearance for WHITESIDE ORTHOLOC II UNICONDYLAR KNEE ..., manufactured by Dow Corning Wright. The device is a Class 2 Orthopedic device with product code HSX cleared through the Traditional 510(k) pathway after a 127-day FDA review.

K881779 · Dow Corning Wright · Orthopedic device
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Aug 1988
Decision
127d
Days
Class 2
Risk

K881779 is an FDA 510(k) clearance for the WHITESIDE ORTHOLOC II UNICONDYLAR KNEE SYSTEM. Classified as Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer (product code HSX), Class II - Special Controls.

Submitted by Dow Corning Wright (Arlington, US). The FDA issued a Cleared decision on August 31, 1988 after a review of 127 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3520 - 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 - K881779

510(k) Number K881779 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received April 26, 1988
Decision Date August 31, 1988
Days to Decision 127 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
5d slower than avg
Panel avg: 122d · This submission: 127d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HSX Device Classification - Class 2, Special Controls

Product Code HSX Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3520
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 - HSX Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer

All 101
Devices cleared under the same product code (HSX) and FDA review panel - the closest regulatory comparables to K881779.
CONCEPT UNICOMPARTMENTAL KNEE SYSTEM
K896648 · Concept, Inc. · Jun 1990
MOD-ML UNICOMPARTMENTAL KNEE PROSTHESIS
K896856 · Osteonics Corp. · Feb 1990
KIRSCHNER UNICOMPARTMENTAL KNEE SYSTEM
K894068 · Kirschner Medical Corp. · Dec 1989
MILLER/GALANTE PRECOAT UNICOMPARTMENTAL KNEE
K880155 · Zimmer, Inc. · Aug 1988
KIRSCHNER UNICONDYLAR KNEE SYSTEM
K873970 · Kirschner Medical Corp. · Dec 1987
HOWMEDICA KINEMATIC III STABILIZER TOTAL KNEE SYS.
K872735 · Howmedica Corp. · Aug 1987