# K980513: Articul/Eze Femoral Heads

- Pathway: 510(k) (Traditional)
- Applicant: DePuy Orthopaedics, Inc.
- Decided: Apr 14, 1998 after 63 days
- Product code: JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3350
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K883460 (1988). 2 ancestors in all.
109 later devices descend from it; 12 cite it directly.
0 of 112 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K883460: Focus Total Hip System, Depuy, Inc. (1988) Summary page 1.
- K952088: Zirconia Articul/Eze Femoral Balls, Depuy, Inc. (1995) Summary page 1.

## Most influential descendants
- K033634: Epsilon Metasul 32MM Acetabular Inserts, Standard and Hooded (2004), 76 descendants of its own
- K053536: Durom Acetabular Component and Metasul LDH Large Diameter Heads (2006), 74 descendants of its own
- K071723: Zimmer Porolock Mis Stem (2008), 73 descendants of its own
- K123392: Avenir Muller Stem (2013), 41 descendants of its own
- K110400: Taperloc Complete Microplasty Stem (2011), 34 descendants of its own

## Indications for use
The Articul/eze Femoral Heads are intended to be used with DePuy femoral hip stems with Articul/eze (12/14mm) male tapers in cemented or cementless total hip arthroplasty for the indications of: a severely painful and/or severely disabled joint resulting from osteoarthritis, traumatic arthritis, or rheumatoid arthritis; avascular necrosis of the femoral head; acute traumatic fracture of the femoral head or neck; a failed previous surgery, including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or other total hip replacement; and certain cases of ankylosis.

Source page: https://510kreport.com/device/K980513
Methodology: https://510kreport.com/methodology