510(k) · Cleared
ClearedConsensus Apex Dome Hole Plug
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
U.S. Medical Products, Inc. · JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Cleared on Mar 15, 1996 as substantially equivalent to K922561 (U.S. Medical Products, Inc., 1993) after a 51-day review. Its family tree reaches back 1 generation to 1993. 5 later devices descend from it.
- Decided
- Mar 15, 1996
- Review
- 51 days
- Class
- Class II
- Product code
- JDI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K922561 (1993). 5 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK922561 Consensus (TM) Total Hip SystemU.S. Medical Products, Inc. · 1993
- This deviceK960340 Consensus Apex Dome Hole PlugU.S. Medical Products, Inc. · 1996
- Descendant · cites it directly · 4 of its ownK111472 Helicon Hip System, Femoral Stem, Helicon Hip System, Femoral Head…Tgm Medical · 2011
- Descendant · 2 generations on · 1 of its ownK121636 Zenith, Femoral Stem Zenith, Distal Centralizer Fomoral Head…Tgm Medical, Inc. · 2012
- Descendant · 2 generations on · 0 of its ownK191826 KeYi Total Hip SystemBeijing Keyi Medical Device Technology Co., Ltd. · 2020
- Descendant · 2 generations on · 0 of its ownK150576 TGM Biolox delta Ceramic HeadsTgm Medical, Inc. · 2015
- Descendant · 2 generations on · 0 of its ownK121509 Treasure Bipolar Head, Femoral Head, Treasure Bipolar Head, InsertTgm Medical, Inc. · 2012
Most influential descendants
Showing 5 of 5 · See all- K111472Helicon Hip System, Femoral Stem, Helicon Hip System, Femoral Head, Cocr, Helicon Hip…Tgm Medical · 2011 · cites it directly4descendants
- K121636Zenith, Femoral Stem Zenith, Distal Centralizer Fomoral Head Acetabular InsertTgm Medical, Inc. · 2012 · 2 generations on1descendant
- K191826KeYi Total Hip SystemBeijing Keyi Medical Device Technology Co., Ltd. · 2020 · 2 generations on0descendants
- K150576TGM Biolox delta Ceramic HeadsTgm Medical, Inc. · 2015 · 2 generations on0descendants
- K121509Treasure Bipolar Head, Femoral Head, Treasure Bipolar Head, InsertTgm Medical, Inc. · 2012 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K922561 | Consensus (TM) Total Hip System | U.S. Medical Products, Inc. | 1993 | — |
| 0 (this device) | K960340 | Consensus Apex Dome Hole Plug | U.S. Medical Products, Inc. | 1996 | — |
| +1 | K111472 | Helicon Hip System, Femoral Stem, Helicon Hip System, Femoral Head, Cocr… | Tgm Medical | 2011 | — |
| +2 | K121636 | Zenith, Femoral Stem Zenith, Distal Centralizer Fomoral Head Acetabular Insert | Tgm Medical, Inc. | 2012 | — |
| +2 | K191826 | KeYi Total Hip System | Beijing Keyi Medical Device Technology Co., Ltd. | 2020 | — |
| +2 | K150576 | TGM Biolox delta Ceramic Heads | Tgm Medical, Inc. | 2015 | — |
| +2 | K121509 | Treasure Bipolar Head, Femoral Head, Treasure Bipolar Head, Insert | Tgm Medical, Inc. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2015 | 1 | 0 |
| 2020 | 1 | 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? (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 |
|---|---|---|---|
| * | K922561 | Consensus (TM) Total Hip SystemSummary page 1…tal/ Polymer classification 21 CFR 888.3350 Substantial Equivalence: equivalent Apex Dome Hole Plug (PMMA) components are as follows: Consensus® Acetabular Cement Pods K922561 SE 07/21/93 Device Description: The Consensus® Apex Dome Hole Plug (PMMA) is intended for use with the Consensus® Total Hip Syst… | 1993 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K111472 | Helicon Hip System, Femoral Stem, Helicon Hip System, Femoral Head, Cocr, Helicon Hip… | 2011 | 4 |
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 CONSENSUS® Apex Dome Hole Plug (PMMA) is indicated for use in:
1. Primary intervention of rheumatoid arthritis, osteoarthritis, post-traumatic arthritis and avascular necrosis with a non-acute fracture of the femoral neck. Osteoarthrosis involving femoral and acetabular articular surfaces.
. Avascular osteonecrosis and/or non-union of acute femoral neck fractures.
. Fracture-dislocation of the hip.
Replacement of unsatisfactory cemented or press fit hip components if sufficient bone stock exists.
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/K960340 · printed Nov 4, 2026
Cite this page
510(k) Report. “K960340: Consensus Apex Dome Hole Plug.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K960340
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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