Cleared Traditional

TITANIUM MODULAR MODULAR COLLARLESS HIP (K895036) - FDA 510(k) Clearance

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

K895036 · Depuy, Inc. · Orthopedic device
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Jan 1990
Decision
175d
Days
Class 2
Risk

K895036 is an FDA 510(k) clearance for the TITANIUM MODULAR MODULAR COLLARLESS 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 January 31, 1990 after a review of 175 days - an extended review cycle.

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 K895036 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received August 09, 1989
Decision Date January 31, 1990
Days to Decision 175 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
53d slower than avg
Panel avg: 122d · This submission: 175d
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 K895036.
OSTEONICS ECSI HIP STEM SERIES
K900836 · Osteonics Corp. · Mar 1990
MODIFIED AML + ACETABULAR CUP PROSTHESIS
K900891 · Depuy, Inc. · Mar 1990
TITANIUM MODULAR COLLARED HIP PROSTHESIS
K895035 · Depuy, Inc. · Jan 1990
QUANTUM HIP STEM
K896325 · Depuy, Inc. · Jan 1990
LORD L.F.R. TOTAL HIP SYSTEM
K884890 · Howmedica Corp. · Dec 1989
MODIFIED GEMINI ACETABULAR CUP
K894298 · Depuy, Inc. · Sep 1989