Cleared Traditional

CONICAL COLLAR HIP PROSTHESIS POROUS COATED (K860002) - FDA 510(k) Clearance

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

K860002 · Kirschner Medical Corp. · Orthopedic device
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Apr 1986
Decision
89d
Days
Class 2
Risk

K860002 is an FDA 510(k) clearance for the CONICAL COLLAR HIP PROSTHESIS POROUS COATED. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (product code JDI), Class II - Special Controls.

Submitted by Kirschner Medical Corp. (Timonium, US). The FDA issued a Cleared decision on April 1, 1986 after a review of 89 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Kirschner Medical Corp. devices

Submission Details

510(k) Number K860002 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received January 02, 1986
Decision Date April 01, 1986
Days to Decision 89 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
33d faster than avg
Panel avg: 122d · This submission: 89d
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 280
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K860002.
EXACTECH TOTAL HIP SYSTEM
K862234 · Exactech, Inc. · Oct 1986
MALLORY/HEAD - PF ACETABULAR COMPONENT
K861114 · Biomet, Inc. · Apr 1986
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
COLLAR LESS AML HIP
K853408 · Depuy, Inc. · Nov 1985