Cleared Traditional

AML TRILOCK REPLACEMENT LINER SYSTEM (K942966) - FDA 510(k) Clearance

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

K942966 · Depuy, Inc. · Orthopedic device
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Oct 1994
Decision
116d
Days
Class 2
Risk

K942966 is an FDA 510(k) clearance for the AML TRILOCK 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 116 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 K942966 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 1994
Decision Date October 14, 1994
Days to Decision 116 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
6d faster than avg
Panel avg: 122d · This submission: 116d
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 279
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K942966.
PARAMOUNT CEMENTED HIP STEM PROTHESIS
K942537 · Depuy, Inc. · Jan 1995
RESTORATION ACETABULAR CUP
K943549 · Osteonics Corp. · Dec 1994
DEPUY CEMENTED HIP PROSTHESIS
K942370 · Depuy, Inc. · Nov 1994
AML TRI-LOCK REPLACEMENT LINER SYSTEM
K943302 · Depuy, Inc. · Oct 1994
PRECISION OSTEOLOCK ACETABULAR COMPONENT
K930275 · Howmedica Corp. · Sep 1994
S.O.S. PROXIMAL FEMUR
K933281 · Wrightmedicaltechnologyinc · Jun 1994