510(k) · Cleared
ClearedProtrusion Cages
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Depuy, Inc. · JDJ Mesh, Surgical, Acetabular, Hip, Prosthesis
Cleared on Aug 1, 1996 after a 71-day review. The FDA summary names its predicate without a number. 225 later devices descend from it.
- Decided
- Aug 1, 1996
- Review
- 71 days
- Class
- Class II
- Product code
- JDJ
- Recalls
- None
- Predicates
- 0
225 later devices descend from it, 4 citing it directly.
- This deviceK962007 Protrusion CagesDepuy, Inc. · 1996
- Descendant · cites it directly · 213 of its ownK001277 Triflange Acetabular Cup SystemDePuy Orthopaedics, Inc. · 2000
- Descendant · 2 generations on · 207 of its ownK031495 Pinnacle Duofix HA Acetabular Cup ProsthesisDePuy Orthopaedics, Inc. · 2003
- Descendant · 3 generations on · 198 of its ownK042344 Excia Total Hip SystemAesculap, Inc. · 2005 · Recalled
- Descendant · 4 generations on · 90 of its ownK060918 Excia Total Hip System 12/14 Trunnion with Ceramic HeadAesculap, Inc. · 2006
- Descendant · 4 generations on · 90 of its ownK060437 Excia Total Hip System with U-CapAesculap, Inc. · 2006
Showing 5 of 225 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 225 · See all- K001277Triflange Acetabular Cup SystemDePuy Orthopaedics, Inc. · 2000 · cites it directly213descendants
- K031495Pinnacle Duofix HA Acetabular Cup ProsthesisDePuy Orthopaedics, Inc. · 2003 · 2 generations on207descendants
- K042344Excia Total Hip SystemAesculap, Inc. · 2005 · 3 generations on198descendants
- K060918Excia Total Hip System 12/14 Trunnion with Ceramic HeadAesculap, Inc. · 2006 · 4 generations on90descendants
- K060437Excia Total Hip System with U-CapAesculap, Inc. · 2006 · 4 generations on90descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K962007 | Protrusion Cages | Depuy, Inc. | 1996 | — |
| +1 | K001277 | Triflange Acetabular Cup System | DePuy Orthopaedics, Inc. | 2000 | — |
| +2 | K031495 | Pinnacle Duofix HA Acetabular Cup Prosthesis | DePuy Orthopaedics, Inc. | 2003 | — |
| +3 | K042344 | Excia Total Hip System | Aesculap, Inc. | 2005 | 10 |
| +4 | K060918 | Excia Total Hip System 12/14 Trunnion with Ceramic Head | Aesculap, Inc. | 2006 | — |
| +4 | K060437 | Excia Total Hip System with U-Cap | Aesculap, Inc. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 5 | 0 |
| 2007 | 1 | 0 |
| 2008 | 6 | 0 |
| 2009 | 5 | 0 |
| 2010 | 6 | 0 |
| 2011 | 12 | 0 |
| 2012 | 16 | 0 |
| 2013 | 13 | 0 |
| 2014 | 6 | 0 |
| 2015 | 6 | 0 |
| 2016 | 5 | 0 |
| 2017 | 12 | 0 |
| 2018 | 9 | 0 |
| 2019 | 6 | 0 |
| 2020 | 9 | 0 |
| 2021 | 17 | 0 |
| 2022 | 15 | 0 |
| 2023 | 17 | 0 |
| 2024 | 13 | 0 |
| 2025 | 19 | 0 |
| 2026 | 17 | 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 JDJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | — | DePuy Protrusio Rings Named without a submission number |
What descends from it? (225)
See all 2254 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K001277 (DePuy Orthopaedics, Inc., 2000) has gone furthest, with 213 descendants of its own.
How does its category compare?
All JDJ devicesJDJ Mesh, Surgical, Acetabular, Hip, Prosthesis: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JDJ
FDA has decided no JDJ device since 2007.
Median 510(k) review, days · JDJ
Too few JDJ 510(k)s in any year since 2007 to give a median.
Recalls per year · JDJ
No recall names JDJ since 2007.
Adverse event reports per year · JDJ
2in 2025
MAUDE reports naming product code JDJ, 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 | 1 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 5 |
| 2011 | 0 | — | 0 | 6 |
| 2012 | 0 | — | 0 | 10 |
| 2013 | 0 | — | 0 | 18 |
| 2014 | 0 | — | 0 | 15 |
| 2015 | 0 | — | 0 | 12 |
| 2016 | 0 | — | 0 | 5 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 0 | — | 0 | 15 |
| 2019 | 0 | — | 0 | 34 |
| 2020 | 0 | — | 0 | 14 |
| 2021 | 0 | — | 0 | 14 |
| 2022 | 0 | — | 0 | 8 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The DePuy Protrusio Cage is intended to be used to reinforce a deficient or weakened medial acetabular wall to prevent the protrusion of an acetabular cup prosthesis into the abdominal cavity and may be indicated for use in cases involving acetabular revision procedures, severe osteoporosis, Protrusio Acetabuli, or a shallow acetabular roof.
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/K962007 · printed Nov 4, 2026
Cite this page
510(k) Report. “K962007: Protrusion Cages.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K962007
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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