Cleared Traditional

K851341 - SYNATOMIC VARIABLE FIT TIBIAL PLATEAU

K851341 is an FDA 510(k) clearance for SYNATOMIC VARIABLE FIT TIBIAL PLATEAU, manufactured by Depuy, Inc.. The device is a Class 2 Orthopedic device with product code KYK cleared through the Traditional 510(k) pathway after a 103-day FDA review.

K851341 · Depuy, Inc. · Orthopedic device
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Jul 1985
Decision
103d
Days
Class 2
Risk

K851341 is an FDA 510(k) clearance for the SYNATOMIC VARIABLE FIT TIBIAL PLATEAU. Classified as Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/composite (product code KYK), Class II - Special Controls.

Submitted by Depuy, Inc. (Warsaw, US). The FDA issued a Cleared decision on July 15, 1985 after a review of 103 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3500 - 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 - K851341

510(k) Number K851341 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 1985
Decision Date July 15, 1985
Days to Decision 103 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
19d faster than avg
Panel avg: 122d · This submission: 103d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KYK Device Classification - Class 2, Special Controls

Product Code KYK Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/composite
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3500
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.