Cleared Traditional

K910940 - ANATOMIC MODULAR KNEE POLYETHYLENE TIBIAL TRAY

K910940 is an FDA 510(k) clearance for ANATOMIC MODULAR KNEE POLYETHYLENE TIBI..., manufactured by Depuy, Inc.. The device is a Class 2 Orthopedic device with product code JWH cleared through the Traditional 510(k) pathway after a 188-day FDA review.

K910940 · Depuy, Inc. · Orthopedic device
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Sep 1991
Decision
188d
Days
Class 2
Risk

K910940 is an FDA 510(k) clearance for the ANATOMIC MODULAR KNEE POLYETHYLENE TIBIAL TRAY. Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by Depuy, Inc. (Warsaw, US). The FDA issued a Cleared decision on September 10, 1991 after a review of 188 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3560 - 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 - K910940

510(k) Number K910940 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 1991
Decision Date September 10, 1991
Days to Decision 188 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
66d slower than avg
Panel avg: 122d · This submission: 188d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JWH Device Classification - Class 2, Special Controls

Product Code JWH Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3560
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 - JWH Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer

All 893
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K910940.
AXIOM TOTAL KNEE SYSTEM, A/P CURVED TIBIAL INSERT
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NATURAL-KNEE ULTRA CONGRUENT TIBIAL INSERT
K912663 · Intermedics Orthopedics · Sep 1991
AGC REVISION KNEE PROTHESIS
K912245 · Biomet, Inc. · Aug 1991
OSTEONICS 7000 SERIES STAND TOTAL KNEE FEMOR COMP
K912147 · Osteonics Corp. · Aug 1991
TOWNLEY TOTAL KNEE (TTK)
K904448 · Biopro, Inc. · Jul 1991