510(k) · Cleared
ClearedStability Hip Stem with Porocoat
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Depuy, Inc. · JDG Prosthesis, Hip, Femoral Component, Cemented, Metal
Cleared on Apr 29, 1993 after a 492-day review. The FDA summary names its predicate without a number. 1 of the 196 devices in its family, counting itself, has a Class I recall. 195 later devices descend from it.
- Decided
- Apr 29, 1993
- Review
- 492 days
- Class
- Class II
- Product code
- JDG
- Recalls
- None
- Predicates
- 0
195 later devices descend from it, 2 citing it directly. 1 of the 196 devices in this family, counting this one, has a Class I recall.
- This deviceK915787 Stability Hip Stem with PorocoatDepuy, Inc. · 1993
- Descendant · cites it directly · 194 of its ownK934457 Stability Hip Stem with PorocoatDepuy, Inc. · 1994
- Descendant · 2 generations on · 188 of its ownK001991 Titan Porocoat Hip ProsthesisDePuy Orthopaedics, Inc. · 2000
- Descendant · 3 generations on · 168 of its ownK042992 Corail Amt Hip ProsthesisDePuy Orthopaedics, Inc. · 2005 · Recalled
- Descendant · 4 generations on · 71 of its ownK082525 Corin Metafix Femoral StemCorin USA · 2010 · Recalled
- Descendant · 5 generations on · 61 of its ownK120362 Metafix Femoral Stem for Hemi-ArthroplastyCorin USA · 2012
Showing 5 of 195 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K071417 Depuy LPS Diaphyseal and Metaphyseal Sleeves2 generations on · 2007
Most influential descendants
Showing 5 of 195 · See all- K934457Stability Hip Stem with PorocoatDepuy, Inc. · 1994 · cites it directly194descendants
- K001991Titan Porocoat Hip ProsthesisDePuy Orthopaedics, Inc. · 2000 · 2 generations on188descendants
- K042992Corail Amt Hip ProsthesisDePuy Orthopaedics, Inc. · 2005 · 3 generations on168descendants
- K082525Corin Metafix Femoral StemCorin USA · 2010 · 4 generations on71descendants
- K120362Metafix Femoral Stem for Hemi-ArthroplastyCorin USA · 2012 · 5 generations on61descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K915787 | Stability Hip Stem with Porocoat | Depuy, Inc. | 1993 | — |
| +1 | K934457 | Stability Hip Stem with Porocoat | Depuy, Inc. | 1994 | — |
| +2 | K001991 | Titan Porocoat Hip Prosthesis | DePuy Orthopaedics, Inc. | 2000 | — |
| +3 | K042992 | Corail Amt Hip Prosthesis | DePuy Orthopaedics, Inc. | 2005 | 1 |
| +4 | K082525 | Corin Metafix Femoral Stem | Corin USA | 2010 | 2 |
| +5 | K120362 | Metafix Femoral Stem for Hemi-Arthroplasty | Corin USA | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2007 | 2 | 1 |
| 2008 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 5 | 0 |
| 2012 | 5 | 0 |
| 2013 | 10 | 0 |
| 2014 | 3 | 0 |
| 2015 | 5 | 0 |
| 2016 | 9 | 0 |
| 2017 | 12 | 0 |
| 2018 | 12 | 0 |
| 2019 | 14 | 0 |
| 2020 | 16 | 0 |
| 2021 | 9 | 0 |
| 2022 | 15 | 0 |
| 2023 | 19 | 0 |
| 2024 | 15 | 0 |
| 2025 | 18 | 0 |
| 2026 | 14 | 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.
1 device in this family has a Class I recall. 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 JDG device
- #1 K212431 Biomet Answer/Impact/Integral Distal…score 3.1 · 2 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | — | S-Rom Total Hip stem Named without a submission number |
What descends from it? (195)
See all 1952 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K071417Depuy LPS Diaphyseal and Metaphyseal SleevesDePuy Orthopaedics, Inc. · 2007 · 2 generations on · ◆ in the 2007 descendants bar of FIG. 14 Class I recalls
What does this lineage say?
- Of its descendants, K934457 (Depuy, Inc., 1994) has gone furthest, with 194 descendants of its own.
How does its category compare?
All JDG devicesJDG Prosthesis, Hip, Femoral Component, Cemented, Metal: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JDG
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · JDG
Too few JDG 510(k)s in any year since 2007 to give a median.
Recalls per year · JDG
4in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JDG
263in 2025
MAUDE reports naming product code JDG, 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 | 0 | — | 0 | 28 |
| 2008 | 0 | — | 0 | 19 |
| 2009 | 0 | — | 2 | 38 |
| 2010 | 0 | — | 0 | 37 |
| 2011 | 0 | — | 0 | 25 |
| 2012 | 0 | — | 0 | 49 |
| 2013 | 0 | — | 3 | 84 |
| 2014 | 0 | — | 0 | 145 |
| 2015 | 0 | — | 0 | 391 |
| 2016 | 0 | — | 0 | 383 |
| 2017 | 0 | — | 0 | 328 |
| 2018 | 1 | — | 0 | 447 |
| 2019 | 0 | — | 0 | 333 |
| 2020 | 1 | — | 0 | 1,046 |
| 2021 | 0 | — | 4 | 1,206 |
| 2022 | 1 | — | 0 | 886 |
| 2023 | 0 | — | 0 | 289 |
| 2024 | 0 | — | 0 | 300 |
| 2025 | 0 | — | 0 | 263 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K915787 · printed Nov 6, 2026
Cite this page
510(k) Report. “K915787: Stability Hip Stem with Porocoat.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K915787
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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