Cleared Traditional

K861114 - MALLORY/HEAD - PF ACETABULAR COMPONENT

K861114 is an FDA 510(k) clearance for MALLORY/HEAD - PF ACETABULAR COMPONENT, manufactured by Biomet, Inc.. The device is a Class 2 Orthopedic device with product code JDI cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K861114 · Biomet, Inc. · Orthopedic device
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Apr 1986
Decision
23d
Days
Class 2
Risk

K861114 is an FDA 510(k) clearance for the MALLORY/HEAD - PF ACETABULAR COMPONENT. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (product code JDI), Class II - Special Controls.

Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on April 17, 1986 after a review of 23 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 Biomet, Inc. devices

FDA 510(k) Submission Details - K861114

510(k) Number K861114 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 25, 1986
Decision Date April 17, 1986
Days to Decision 23 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
99d faster than avg
Panel avg: 122d · This submission: 23d
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 451
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K861114.
EXACTECH TOTAL HIP SYSTEM
K862234 · Exactech, Inc. · Oct 1986
INTERNATIONAL TOTAL HIP SYSTEM
K862225 · Richards Medical Co., Inc. · Jul 1986
CM-6 TOTAL HIP SYSTEM
K861930 · Kirschner Medical Corp. · Jun 1986
MODULAR PRESS FIT (MPF) STEM
K855200 · Depuy, Inc. · Apr 1986
CONICAL COLLAR HIP PROSTHESIS POROUS COATED
K860002 · Kirschner Medical Corp. · Apr 1986
HPS II SMOOTH STEM
K860701 · Depuy, Inc. · Mar 1986