Cleared Traditional

K910596 - DCW MODULAR DISTAL FEMORAL SYSTEM

K910596 is an FDA 510(k) clearance for DCW MODULAR DISTAL FEMORAL SYSTEM, manufactured by Dow Corning Wright. The device is a Class 2 Orthopedic device with product code KRO cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K910596 · Dow Corning Wright · Orthopedic device
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May 1991
Decision
106d
Days
Class 2
Risk

K910596 is an FDA 510(k) clearance for the DCW MODULAR DISTAL FEMORAL SYSTEM. Classified as Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer (product code KRO), Class II - Special Controls.

Submitted by Dow Corning Wright (Arlington, US). The FDA issued a Cleared decision on May 29, 1991 after a review of 106 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3510 - 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 - K910596

510(k) Number K910596 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 1991
Decision Date May 29, 1991
Days to Decision 106 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
16d faster than avg
Panel avg: 122d · This submission: 106d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KRO Device Classification - Class 2, Special Controls

Product Code KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3510
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 - KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer

All 71
Devices cleared under the same product code (KRO) and FDA review panel - the closest regulatory comparables to K910596.
HOWMEDICA MODULAR REPLACEMENT SYSTEM - DISTAL FEMORAL/PROXIMAL TIBIAL SEGMENTS
K972401 · Howmedica Corp. · Jul 1998
FINN KNEE SYSTEM
K945028 · Biomet, Inc. · Feb 1996
FINN KNEE PROSTHESIS
K910877 · Biomet, Inc. · Jul 1991
S-ROM/NOILES MARK 3
K896048 · Joint Medical Products Corp. · Mar 1990
KINEMATIC II KNEE SYSTEM
K823420 · Howmedica Corp. · Feb 1983
NATURALYTE BICARBONATE DIALYSATE 4400
K823115 · Erika, Inc. · Dec 1982