Cleared Traditional

K911595 - INFINITY(TM) POROUS-COATED TROCHANTERIC...

K911595 is an FDA 510(k) clearance for INFINITY(TM) POROUS-COATED TROCHANTERIC..., manufactured by Dow Corning Wright. The device is a Class 2 Orthopedic device with product code JDG cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K911595 · Dow Corning Wright · Orthopedic device
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Jul 1991
Decision
94d
Days
Class 2
Risk

K911595 is an FDA 510(k) clearance for the INFINITY(TM) POROUS-COATED TROCHANTERIC MODULE. Classified as Prosthesis, Hip, Femoral Component, Cemented, Metal (product code JDG), Class II - Special Controls.

Submitted by Dow Corning Wright (Arlington, US). The FDA issued a Cleared decision on July 12, 1991 after a review of 94 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3360 - 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 - K911595

510(k) Number K911595 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received April 09, 1991
Decision Date July 12, 1991
Days to Decision 94 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
28d faster than avg
Panel avg: 122d · This submission: 94d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JDG Device Classification - Class 2, Special Controls

Product Code JDG Prosthesis, Hip, Femoral Component, Cemented, Metal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3360
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 - JDG Prosthesis, Hip, Femoral Component, Cemented, Metal

All 43
Devices cleared under the same product code (JDG) and FDA review panel - the closest regulatory comparables to K911595.
S-ROM TOTAL HIP REPLACEMENT SYSTEM
K935078 · Joint Medical Products Corp. · Mar 1994
BRIDGE(TM) HIP SYSTEM
K933871 · Wrightmedicaltechnologyinc · Feb 1994
STABILITY HIP STEM WITH POROCOAT
K915787 · Depuy, Inc. · Apr 1993
OPTI-FIX COLLARED FEMORAL COMPONENTS
K874868 · Richards Medical Co., Inc. · Jan 1988
PROXIMAL FEMORAL REPLACEMENT PROSTHESIS
K874575 · Dow Corning Wright · Jan 1988
AML CALCAR FEMORAL PROSTHESIS
K874100 · Depuy, Inc. · Dec 1987