Cleared Traditional

INFINITY(TM) POROUS-COATED TROCHANTERIC MODULE (K911595) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K911595 · Dow Corning Wright · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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
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.

Device Classification

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 26
Devices cleared under the same product code (JDG) and FDA review panel - the closest regulatory comparables to K911595.
CO-CR ANSWER FEMORAL COMPONENT
K931194 · Biomet, Inc. · May 1994
BRIDGE(TM) HIP SYSTEM
K933871 · Wrightmedicaltechnologyinc · Feb 1994
STABILITY HIP STEM WITH POROCOAT
K915787 · Depuy, Inc. · Apr 1993
AML CALCAR FEMORAL PROSTHESIS
K874100 · Depuy, Inc. · Dec 1987
HOWMEDICA PCA COLLARED FEMORAL STEM
K873458 · Howmedica Corp. · Sep 1987
PRECISION HIP LONG STEM FEMORAL COMPONENT SYSTEM
K873089 · Howmedica Corp. · Sep 1987