Cleared Traditional

K844355 - SYNATOMIC STANDARD TIBIAL PLATEAU

K844355 is an FDA 510(k) clearance for SYNATOMIC STANDARD TIBIAL PLATEAU, manufactured by Depuy, Inc.. The device is a Class 2 Orthopedic device with product code HSX cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K844355 · Depuy, Inc. · Orthopedic device
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Feb 1985
Decision
90d
Days
Class 2
Risk

K844355 is an FDA 510(k) clearance for the SYNATOMIC STANDARD TIBIAL PLATEAU. Classified as Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer (product code HSX), Class II - Special Controls.

Submitted by Depuy, Inc. (Warsaw, US). The FDA issued a Cleared decision on February 7, 1985 after a review of 90 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 Depuy, Inc. devices

FDA 510(k) Submission Details - K844355

510(k) Number K844355 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 1984
Decision Date February 07, 1985
Days to Decision 90 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
32d faster than avg
Panel avg: 122d · This submission: 90d
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 113
Devices cleared under the same product code (HSX) and FDA review panel - the closest regulatory comparables to K844355.
POROCOAT SYNATOMIC UNICONDYLAR KNEE
K853020 · Depuy, Inc. · Nov 1985
FREEMAN UNI-COMPARTMENTAL KNEE
K853268 · Protek, Inc. · Sep 1985
TRICON REVISION TOTAL KNEE SYSTEM
K844706 · Richards Medical Co., Inc. · Feb 1985
KENNEDY TIBIAL COMPONENT
K831513 · Biomet, Inc. · Jul 1983
GEO-TIBIAL RETAINER ROTATIONAL
K803235 · Zimmer, Inc. · Feb 1981
MEDICAL COMPARTMENT KNEE PROSTHESIS
K800640 · Dow Corning Wright · Apr 1980