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 Corp. · LZN Cement Obturator
Cleared on May 16, 1995 after a 692-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 45 later devices descend from it.
- Decided
- May 16, 1995
- Review
- 692 days
- Class
- Class II
- Product code
- LZN
- Recalls
- None
- Predicates
- 0
45 later devices descend from it, 2 citing it directly.
- This deviceK933077 Exeter Intramedullary Bone PlugHowmedica Corp. · 1995
- Descendant · cites it directly · 44 of its ownK980843 Exeter Intramedullary Bone PlugHowmedica, Inc. · 1998
- Descendant · 2 generations on · 25 of its ownK982918 Depuy C-Stem SystemDePuy Orthopaedics, Inc. · 1998
- Descendant · 3 generations on · 23 of its ownK042959 Depuy C-Stem Amt Hip ProsthesisDePuy Orthopaedics, Inc. · 2004
- Descendant · 4 generations on · 14 of its ownK082239 Depuy C-Stem AmtDePuy Orthopaedics, Inc. · 2008
- Descendant · 3 generations on · 14 of its ownK013350 Modification to Depuy C-Stem SystemDePuy Orthopaedics, Inc. · 2001
Showing 5 of 45 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 45 · See all- K980843Exeter Intramedullary Bone PlugHowmedica, Inc. · 1998 · cites it directly44descendants
- K982918Depuy C-Stem SystemDePuy Orthopaedics, Inc. · 1998 · 2 generations on25descendants
- K042959Depuy C-Stem Amt Hip ProsthesisDePuy Orthopaedics, Inc. · 2004 · 3 generations on23descendants
- K082239Depuy C-Stem AmtDePuy Orthopaedics, Inc. · 2008 · 4 generations on14descendants
- K013350Modification to Depuy C-Stem SystemDePuy Orthopaedics, Inc. · 2001 · 3 generations on14descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K933077 | Exeter Intramedullary Bone Plug | Howmedica Corp. | 1995 | — |
| +1 | K980843 | Exeter Intramedullary Bone Plug | Howmedica, Inc. | 1998 | — |
| +2 | K982918 | Depuy C-Stem System | DePuy Orthopaedics, Inc. | 1998 | — |
| +3 | K042959 | Depuy C-Stem Amt Hip Prosthesis | DePuy Orthopaedics, Inc. | 2004 | — |
| +4 | K082239 | Depuy C-Stem Amt | DePuy Orthopaedics, Inc. | 2008 | — |
| +3 | K013350 | Modification to Depuy C-Stem System | DePuy Orthopaedics, Inc. | 2001 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 3 | 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LZN? 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 LZN device
- #1 K220838 Artisan Bone Plug, Universal Cement Restrictorscore 11.8 · 9 generations · no Class I recall
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (45)
See all 452 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, K980843 (Howmedica, Inc., 1998) has gone furthest, with 44 descendants of its own.
How does its category compare?
All LZN devicesLZN Cement Obturator: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LZN
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · LZN
Too few LZN 510(k)s in any year since 2007 to give a median.
Recalls per year · LZN
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LZN
6in 2025
MAUDE reports naming product code LZN, 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 | 2 |
| 2009 | 0 | — | 0 | 3 |
| 2010 | 0 | — | 0 | 7 |
| 2011 | 0 | — | 0 | 3 |
| 2012 | 0 | — | 0 | 13 |
| 2013 | 0 | — | 0 | 4 |
| 2014 | 0 | — | 0 | 30 |
| 2015 | 0 | — | 0 | 41 |
| 2016 | 0 | — | 0 | 6 |
| 2017 | 0 | — | 0 | 6 |
| 2018 | 0 | — | 0 | 8 |
| 2019 | 0 | — | 0 | 11 |
| 2020 | 0 | — | 0 | 11 |
| 2021 | 0 | — | 0 | 12 |
| 2022 | 1 | — | 1 | 6 |
| 2023 | 0 | — | 0 | 13 |
| 2024 | 0 | — | 0 | 7 |
| 2025 | 0 | — | 0 | 6 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K933077 · printed Nov 4, 2026
Cite this page
510(k) Report. “K933077: 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/K933077
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026