510(k) · Cleared
ClearedArticul/Eze Femoral Heads
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
DePuy Orthopaedics, Inc. · JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Cleared on Apr 14, 1998 as substantially equivalent to K883460 (Depuy, Inc., 1988) and 1 other predicate after a 63-day review. Its family tree reaches back 1 generation to 1988. 109 later devices descend from it.
- Decided
- Apr 14, 1998
- Review
- 63 days
- Class
- Class II
- Product code
- JDI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K883460 (1988). 2 ancestors in all. 109 later devices descend from it, 12 citing it directly.
- Root · 1 generation backK883460 Focus Total Hip SystemDepuy, Inc. · 1988
- This deviceK980513 Articul/Eze Femoral HeadsDePuy Orthopaedics, Inc. · 1998
- Descendant · cites it directly · 76 of its ownK033634 Epsilon Metasul 32MM Acetabular Inserts, Standard and HoodedCenterpulse Orthopedics, Inc. · 2004 · Recalled
- Descendant · 2 generations on · 74 of its ownK053536 Durom Acetabular Component and Metasul LDH Large Diameter HeadsZimmer GmbH · 2006 · Recalled
- Descendant · 3 generations on · 73 of its ownK071723 Zimmer Porolock Mis StemZimmer GmbH · 2008 · Recalled
- Descendant · 4 generations on · 41 of its ownK123392 Avenir Muller StemZimmer GmbH · 2013 · Recalled
- Descendant · 4 generations on · 34 of its ownK110400 Taperloc Complete Microplasty StemBiomet Manufacturing Corp · 2011
Showing 5 of 109 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 109 · See all- K033634Epsilon Metasul 32MM Acetabular Inserts, Standard and HoodedCenterpulse Orthopedics, Inc. · 2004 · cites it directly76descendants
- K053536Durom Acetabular Component and Metasul LDH Large Diameter HeadsZimmer GmbH · 2006 · 2 generations on74descendants
- K071723Zimmer Porolock Mis StemZimmer GmbH · 2008 · 3 generations on73descendants
- K123392Avenir Muller StemZimmer GmbH · 2013 · 4 generations on41descendants
- K110400Taperloc Complete Microplasty StemBiomet Manufacturing Corp · 2011 · 4 generations on34descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K883460 | Focus Total Hip System | Depuy, Inc. | 1988 | — |
| 0 (this device) | K980513 | Articul/Eze Femoral Heads | DePuy Orthopaedics, Inc. | 1998 | — |
| +1 | K033634 | Epsilon Metasul 32MM Acetabular Inserts, Standard and Hooded | Centerpulse Orthopedics, Inc. | 2004 | 2 |
| +2 | K053536 | Durom Acetabular Component and Metasul LDH Large Diameter Heads | Zimmer GmbH | 2006 | 13 |
| +3 | K071723 | Zimmer Porolock Mis Stem | Zimmer GmbH | 2008 | 2 |
| +4 | K123392 | Avenir Muller Stem | Zimmer GmbH | 2013 | 4 |
| +4 | K110400 | Taperloc Complete Microplasty Stem | Biomet Manufacturing Corp | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 4 | 0 |
| 2013 | 5 | 0 |
| 2014 | 6 | 0 |
| 2015 | 4 | 0 |
| 2016 | 7 | 0 |
| 2017 | 5 | 0 |
| 2018 | 6 | 0 |
| 2019 | 10 | 0 |
| 2020 | 7 | 0 |
| 2021 | 4 | 0 |
| 2022 | 2 | 0 |
| 2023 | 7 | 0 |
| 2024 | 12 | 0 |
| 2025 | 12 | 0 |
| 2026 | 10 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JDI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new JDI device
- #1 K253515 Zimmer Biomet OSS™ Orthopedic Salvage System…score 15.2 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K883460 | Focus Total Hip SystemSummary page 1…er/metal semi- constrained porous-coated uncemented prosthesis DEVICE PRODUCT CODES: 87 JDI and 87 LPH SUBSTANTIALLY EQUIVALENT DEVICES: DePuy Focus Total Hip System (K883460) DePuy Zirconia Articul/eze Femoral Balls (K952088) DEVICE DESCRIPTION AND INTENDED USE: The subject Articul/eze Femoral Heads… | 1988 |
| * | K952088 | Zirconia Articul/Eze Femoral BallsSummary page 1…prosthesis DEVICE PRODUCT CODES: 87 JDI and 87 LPH SUBSTANTIALLY EQUIVALENT DEVICES: DePuy Focus Total Hip System (K883460) DePuy Zirconia Articul/eze Femoral Balls (K952088) DEVICE DESCRIPTION AND INTENDED USE: The subject Articul/eze Femoral Heads are Co-Cr-Mo alloy femoral heads available in: a 22… | 1995 |
What descends from it? (109)
See all 10912 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K033634 | Epsilon Metasul 32MM Acetabular Inserts, Standard and Hooded | 2004 | 76 |
| K060031 | Depuy Modular M Heads | 2006 | 18 |
| K112158 | Modulus Stems, Modulus Necks, Modular Femoral Heads, Cemented Cups, Lock Bipolar Heads | 2012 | 13 |
| K082585 | Depuy Asphere M-Spec Head | 2008 | 7 |
| K222296 | ARTICUL/EZE Ceramic Heads | 2023 | 6 |
| K120599 | Depuy M-Spec 36MM Femoral Heads | 2013 | 6 |
| K231873 | DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip… | 2024 | 5 |
| K141327 | Minima S System | 2014 | 5 |
| K160895 | Initia Total Hip System & BIOCERAM AZUL (R) HEAD | 2016 | 2 |
| K223745 | Novae® Dual Mobility System, Hype® Hip System | 2023 | 1 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All JDI devicesJDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JDI
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JDI
59in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JDI
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JDI
1,644in 2025
MAUDE reports naming product code JDI, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 3 | 81 | 26 | 696 |
| 2008 | 5 | 96 | 6 | 810 |
| 2009 | 3 | 65 | 3 | 964 |
| 2010 | 0 | — | 3 | 2,040 |
| 2011 | 2 | — | 5 | 3,160 |
| 2012 | 4 | 167 | 4 | 5,122 |
| 2013 | 3 | 176 | 11 | 5,206 |
| 2014 | 3 | 98 | 3 | 4,968 |
| 2015 | 3 | 190 | 1 | 4,906 |
| 2016 | 4 | 166 | 5 | 3,995 |
| 2017 | 1 | — | 5 | 6,135 |
| 2018 | 1 | — | 1 | 6,728 |
| 2019 | 2 | — | 1 | 7,407 |
| 2020 | 7 | 247 | 77 | 4,015 |
| 2021 | 3 | 162 | 0 | 3,170 |
| 2022 | 3 | 69 | 0 | 1,978 |
| 2023 | 2 | — | 0 | 1,635 |
| 2024 | 3 | 59 | 0 | 1,821 |
| 2025 | 1 | — | 1 | 1,644 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K980513 · printed Nov 4, 2026
Cite this page
510(k) Report. “K980513: Articul/Eze Femoral Heads.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K980513
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026