510(k) · Cleared
ClearedExeter Intramedullary Bone Plug
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Howmedica, Inc. · JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Cleared on Jun 2, 1998 as substantially equivalent to K933077 (Howmedica Corp., 1995) and 1 other predicate after a 90-day review. Its family tree reaches back 2 generations to 1989. 44 later devices descend from it.
- Decided
- Jun 2, 1998
- Review
- 90 days
- Class
- Class II
- Product code
- JDI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K891454 (1989). 4 ancestors in all. 44 later devices descend from it, 5 citing it directly.
- Root · 2 generations backK891454 Exeter II Total Hip SystemHowmedica Corp. · 1989
- 1 generation backK974054 Distal Centralizer, Exeter II Hip SystemHowmedica, Inc. · 1997 · Recalled
- This deviceK980843 Exeter Intramedullary Bone PlugHowmedica, Inc. · 1998
- Descendant · cites it directly · 25 of its ownK982918 Depuy C-Stem SystemDePuy Orthopaedics, Inc. · 1998
- Descendant · 2 generations on · 23 of its ownK042959 Depuy C-Stem Amt Hip ProsthesisDePuy Orthopaedics, Inc. · 2004
- Descendant · 3 generations on · 14 of its ownK082239 Depuy C-Stem AmtDePuy Orthopaedics, Inc. · 2008
- Descendant · 2 generations on · 14 of its ownK013350 Modification to Depuy C-Stem SystemDePuy Orthopaedics, Inc. · 2001
- Descendant · 2 generations on · 8 of its ownK220216 C-Stem AMT LE ProsthesisDepuy Ireland UC · 2022
Showing 5 of 44 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 44 · See all- K982918Depuy C-Stem SystemDePuy Orthopaedics, Inc. · 1998 · cites it directly25descendants
- K042959Depuy C-Stem Amt Hip ProsthesisDePuy Orthopaedics, Inc. · 2004 · 2 generations on23descendants
- K082239Depuy C-Stem AmtDePuy Orthopaedics, Inc. · 2008 · 3 generations on14descendants
- K013350Modification to Depuy C-Stem SystemDePuy Orthopaedics, Inc. · 2001 · 2 generations on14descendants
- K220216C-Stem AMT LE ProsthesisDepuy Ireland UC · 2022 · 2 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K891454 | Exeter II Total Hip System | Howmedica Corp. | 1989 | — |
| −1 | K974054 | Distal Centralizer, Exeter II Hip System | Howmedica, Inc. | 1997 | 3 |
| 0 (this device) | K980843 | Exeter Intramedullary Bone Plug | Howmedica, Inc. | 1998 | — |
| +1 | K982918 | Depuy C-Stem System | DePuy Orthopaedics, Inc. | 1998 | — |
| +2 | K042959 | Depuy C-Stem Amt Hip Prosthesis | DePuy Orthopaedics, Inc. | 2004 | — |
| +3 | K082239 | Depuy C-Stem Amt | DePuy Orthopaedics, Inc. | 2008 | — |
| +2 | K013350 | Modification to Depuy C-Stem System | DePuy Orthopaedics, Inc. | 2001 | — |
| +2 | K220216 | C-Stem AMT LE Prosthesis | Depuy Ireland UC | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 2 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
| 2008 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 3 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 3 | 0 |
| 2020 | 4 | 0 |
| 2021 | 2 | 0 |
| 2022 | 3 | 0 |
| 2023 | 5 | 0 |
| 2024 | 3 | 0 |
| 2025 | 7 | 0 |
| 2026 | 4 | 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 |
|---|---|---|---|
| * | K933077 | Exeter Intramedullary Bone PlugSummary page 1…equivalence in intended use, design, materials, operational principles, and relative indications and contraindications to the Howmedica's polyethylene Exeter Bone Plug, (K933077) and Exeter Il Distal Centralizer (K974054). ERVICE, N Tt -/C DEPARTMENT OF HEALTH & HUMAN SERVICES Public Healt… | 1995 |
| * | K974054 | Distal Centralizer, Exeter II Hip SystemSummary page 1…als, operational principles, and relative indications and contraindications to the Howmedica's polyethylene Exeter Bone Plug, (K933077) and Exeter Il Distal Centralizer (K974054). ERVICE, N Tt -/C DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service WEALTY < 4y, & a'vlh ] . Food… | 1997 |
What descends from it? (44)
See all 445 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?
- The line of descent spans 9 years and passes through 2 companies; a new generation was cleared every 8.5 years on median.
- 2 of the 4 ancestors have a recall of any class.
- Of its descendants, K982918 (DePuy Orthopaedics, Inc., 1998) has gone furthest, with 25 descendants of its own.
- 1 other device also cites its predicate K933077.
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 Exeter II Intramedullary Bone Plug is intended to be used to restrict the
migration of bone cement down the femoral canal and permit cement
pressurization during total hip arthroplasty. The Exeter Intramedullary Bone
Plug is intended to be used with bone cement.
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/K980843 · printed Nov 4, 2026
Cite this page
510(k) Report. “K980843: Exeter Intramedullary Bone Plug.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K980843
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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