Cleared Traditional

K862136 - MODIFIED WHITESIDE POSTERIOR STABILIZED...

K862136 is an FDA 510(k) clearance for MODIFIED WHITESIDE POSTERIOR STABILIZED..., 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 40-day FDA review.

K862136 · Dow Corning Wright · Orthopedic device
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Jul 1986
Decision
40d
Days
Class 2
Risk

K862136 is an FDA 510(k) clearance for the MODIFIED WHITESIDE POSTERIOR STABILIZED TOTAL KNEE. 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 July 14, 1986 after a review of 40 days - a notably fast clearance cycle.

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: 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 - K862136

510(k) Number K862136 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 1986
Decision Date July 14, 1986
Days to Decision 40 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
82d faster than avg
Panel avg: 122d · This submission: 40d
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 K862136.
INSALL/BURSTEIN(TM)* II TIBIAL WEDGES
K862632 · Zimmer, Inc. · Mar 1987
OMNIFIT TOTAL KNEE PROSTHESIS SYSTEM
K862837 · Osteonics Corp. · Dec 1986
WHITESIDE CONDYLAR II TOTAL KNEE PROSTHESIS
K861715 · Dow Corning Wright · Jul 1986
TRICON UNICOMPARTMENTAL KNEE SYSTEM
K854325 · Richards Medical Co., Inc. · Dec 1985
POROCOAT SYNATOMIC UNICONDYLAR KNEE
K853020 · Depuy, Inc. · Nov 1985
TRICON REVISION TOTAL KNEE SYSTEM
K844706 · Richards Medical Co., Inc. · Feb 1985