Cleared Traditional

K895035 - TITANIUM MODULAR COLLARED HIP PROSTHESIS

K895035 is an FDA 510(k) clearance for TITANIUM MODULAR COLLARED HIP PROSTHESIS, manufactured by Depuy, Inc.. The device is a Class 2 Orthopedic device with product code JDI cleared through the Traditional 510(k) pathway after a 175-day FDA review.

K895035 · Depuy, Inc. · Orthopedic device
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Jan 1990
Decision
175d
Days
Class 2
Risk

K895035 is an FDA 510(k) clearance for the TITANIUM MODULAR COLLARED HIP PROSTHESIS. 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

FDA 510(k) Submission Details - K895035

510(k) Number K895035 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.

JDI Device Classification - Class 2, Special Controls

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 516
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K895035.
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K900891 · Depuy, Inc. · Mar 1990
TITANIUM MODULAR MODULAR COLLARLESS HIP
K895036 · Depuy, Inc. · Jan 1990
QUANTUM HIP STEM
K896325 · Depuy, Inc. · Jan 1990
DIMENSION REVISION TOTAL HIP SYSTEM
K895636 · Kirschner Medical Corp. · Dec 1989