Cleared Traditional

K943302 - AML TRI-LOCK REPLACEMENT LINER SYSTEM

K943302 is the FDA 510(k) clearance for AML TRI-LOCK REPLACEMENT LINER SYSTEM by Depuy, Inc.. It is a Class 2 Orthopedic device (product code JDI) cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K943302 · Depuy, Inc. · Orthopedic device
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Oct 1994
Decision
98d
Days
Class 2
Risk

K943302 is an FDA 510(k) clearance for the AML TRI-LOCK REPLACEMENT LINER SYSTEM. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (product code JDI), Class II - Special Controls.

Submitted by Depuy, Inc. (Warsaw, US). The FDA issued a Cleared decision on October 14, 1994 after a review of 98 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3350 - 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

Submission Details

510(k) Number K943302 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 08, 1994
Decision Date October 14, 1994
Days to Decision 98 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
24d faster than avg
Panel avg: 122d · This submission: 98d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JDI Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3350
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 - JDI Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented

All 451
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K943302.
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K936126 · Howmedica, Inc. · Oct 1994
AML TRILOCK REPLACEMENT LINER SYSTEM
K942966 · Depuy, Inc. · Oct 1994
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K941617 · Intermedics Orthopedics · Oct 1994
OPTION SHELL
K942406 · Intermedics Orthopedics · Oct 1994
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K942611 · Encore Orthopedics, Inc. · Sep 1994