Cleared Traditional

K855200 - MODULAR PRESS FIT (MPF) STEM

K855200 is the FDA 510(k) clearance for MODULAR PRESS FIT (MPF) STEM by Depuy, Inc.. It is a Class 2 Orthopedic device (product code JDI) cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K855200 · Depuy, Inc. · Orthopedic device
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Apr 1986
Decision
95d
Days
Class 2
Risk

K855200 is an FDA 510(k) clearance for the MODULAR PRESS FIT (MPF) STEM. 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 April 1, 1986 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 K855200 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 1985
Decision Date April 01, 1986
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 451
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K855200.
INTERNATIONAL TOTAL HIP SYSTEM
K862225 · Richards Medical Co., Inc. · Jul 1986
CM-6 TOTAL HIP SYSTEM
K861930 · Kirschner Medical Corp. · Jun 1986
MALLORY/HEAD - PF ACETABULAR COMPONENT
K861114 · Biomet, Inc. · Apr 1986
CONICAL COLLAR HIP PROSTHESIS POROUS COATED
K860002 · Kirschner Medical Corp. · Apr 1986
HPS II SMOOTH STEM
K860701 · Depuy, Inc. · Mar 1986
ARTHOPOR-ACETABULAR COMPONENT
K844050 · Joint Medical Products Corp. · Dec 1985