Cleared Traditional

COLLAR LESS AML HIP (K853408) - FDA 510(k) Clearance

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

K853408 · Depuy, Inc. · Orthopedic device
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Nov 1985
Decision
95d
Days
Class 2
Risk

K853408 is an FDA 510(k) clearance for the COLLAR LESS AML HIP. 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 November 15, 1985 after a review of 95 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 K853408 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received August 12, 1985
Decision Date November 15, 1985
Days to Decision 95 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
27d faster than avg
Panel avg: 122d · This submission: 95d
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 K853408.
MODULAR PRESS FIT (MPF) STEM
K855200 · Depuy, Inc. · Apr 1986
HPS II SMOOTH STEM
K860701 · Depuy, Inc. · Mar 1986
P.C.A. UNIVERSAL ACETABULAR COMPONENT SYSTEM
K853886 · Howmedica Corp. · Nov 1985
NEW JERSEY MODULAR FEMORAL HIP
K853655 · Depuy, Inc. · Sep 1985
POROUS APF/MODULAR FEMORAL COMPONENT
K852585 · Biomet, Inc. · Aug 1985
HOWMEDICA CEMENTED FLANGED ACETABULAR COMPONENT SY
K852546 · Howmedica Corp. · Aug 1985