Cleared Traditional

K861979 - AML II TITANIUM ACETABULUM PROSTHESIS

K861979 is an FDA 510(k) clearance for AML II TITANIUM ACETABULUM 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 239-day FDA review.

K861979 · Depuy, Inc. · Orthopedic device
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Jan 1987
Decision
239d
Days
Class 2
Risk

K861979 is an FDA 510(k) clearance for the AML II TITANIUM ACETABULUM 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 15, 1987 after a review of 239 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 - K861979

510(k) Number K861979 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received May 21, 1986
Decision Date January 15, 1987
Days to Decision 239 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
117d slower than avg
Panel avg: 122d · This submission: 239d
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 K861979.
MICROSTRUCTURED SPHERICAL ACETABULAR COMPONENTS
K870216 · Osteonics Corp. · Mar 1987
THREADED ACETABULAR COMPONENT
K870445 · Johnson & Johnson Professionals, Inc. · Mar 1987
MODIFIED PROTASUL 100 (TI-6A1-7NB) ALLOY
K861988 · Protek, Inc. · Feb 1987
PROFILE HIP ACETABULUM PROSTHESIS
K863184 · Depuy, Inc. · Jan 1987
UNIVERSAL ACETABULAR COMPONENT
K861433 · Biomet, Inc. · Oct 1986
EXACTECH TOTAL HIP SYSTEM
K862234 · Exactech, Inc. · Oct 1986