Cleared Traditional

K953694 - DEPUY VISION AML HIP PROTHESIS

K953694 is an FDA 510(k) clearance for DEPUY VISION AML HIP PROTHESIS, manufactured by Depuy, Inc.. The device is a Class 2 Orthopedic device with product code LPH cleared through the Traditional 510(k) pathway after a 177-day FDA review.

K953694 · Depuy, Inc. · Orthopedic device
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Feb 1996
Decision
177d
Days
Class 2
Risk

K953694 is an FDA 510(k) clearance for the DEPUY VISION AML HIP PROTHESIS. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (product code LPH), Class II - Special Controls.

Submitted by Depuy, Inc. (Warsaw, US). The FDA issued a Cleared decision on February 1, 1996 after a review of 177 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3358 - 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 - K953694

510(k) Number K953694 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 1995
Decision Date February 01, 1996
Days to Decision 177 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
55d slower than avg
Panel avg: 122d · This submission: 177d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LPH Device Classification - Class 2, Special Controls

Product Code LPH Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3358
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 - LPH Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented

All 543
Devices cleared under the same product code (LPH) and FDA review panel - the closest regulatory comparables to K953694.
HOWMEDICA ASYMMETRIC STEM FEMORAL COMPONENT
K955871 · Howmedica Corp. · Mar 1996
ARTHOPOR I & II ACETABULAR CUP/ARTHOPOR II OBLONG ACETABULAR CUP
K955511 · Joint Medical Products Corp. · Feb 1996
NEXFLEX FEMORAL STEM, STANDARD DESIGN
K955170 · Nexmed, Inc. · Feb 1996
DEPUY VISION SOLUTION HIP PROSTHESIS
K953703 · Depuy, Inc. · Feb 1996
RIM FLARE ACETABULAR COMPONENT
K955033 · Intermedics Orthopedics · Jan 1996
MICRO-SEAL ACETABULAR SYSTEM
K955271 · Whiteside Instruments · Jan 1996