510(k) · Cleared
Recalled · 2010Distal Centralizer, Exeter II Hip System
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 Dec 23, 1997 as substantially equivalent to K936127 (Howmedica, Inc., 1994) and 1 other predicate after a 57-day review. Its family tree reaches back 1 generation to 1989. 45 later devices descend from it. It has been recalled 3 times.
- Decided
- Dec 23, 1997
- Review
- 57 days
- Class
- Class II
- Product code
- JDI
- Recalls
- 3
- Predicates
- 2
Its longest line of descent runs back 1 generation to K891454 (1989). 2 ancestors in all. 45 later devices descend from it, 8 citing it directly.
- Root · 1 generation backK891454 Exeter II Total Hip SystemHowmedica Corp. · 1989
- This deviceK974054 Distal Centralizer, Exeter II Hip SystemHowmedica, Inc. · 1997
- Descendant · cites it directly · 44 of its ownK980843 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
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 · 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K891454 | Exeter II Total Hip System | Howmedica Corp. | 1989 | — |
| 0 (this device) | K974054 | Distal Centralizer, Exeter II Hip System | Howmedica, Inc. | 1997 | — |
| +1 | 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 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
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), 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 |
|---|---|---|---|
| * | K936127 | Howmedica Premium Femoral ComponentSummary page 1…erational principles, and relative indications and contraindications to Howmedica's currently marketed centralizers. These include the Definition Hip System centralizer (K 936127), and the currently marketed Exeter || Distal Centralizer (K 891445). SERVICE [ I8 « WEALTH o 4y C DEPARTMENT O… | 1994 |
| * | K891454 | Exeter II Total Hip System Our OCR of the scanned summary read K891445, FDA’s number for Latex Examination Gloves (Superior Healthcare Group, Inc.). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “Exeter II Distal Centralizer”. | 1989 |
What descends from it? (45)
See all 458 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K980843 | Exeter Intramedullary Bone Plug | 1998 | 44 |
| K982918 | Depuy C-Stem System | 1998 | 25 |
| K152084 | Bencox M Stem (Bencox Hip System) and Bencox ID Cemented Stem (with Centralizer) &… | 2016 | 7 |
| K191414 | EXETER Centralizer, EXETER 2.5mm Plug | 2019 | 5 |
| K172857 | Latitud Hip Replacement System | 2018 | 5 |
| K133370 | Remedy Hip Stem, Pegasus Hip Stem, Evolve Helios Hip Stem, Evolve Masters Hip Stem… | 2014 | 5 |
| K180973 | Libertas Hip Replacement System | 2018 | 3 |
| K983136 | Depuy Luster Stem | 1998 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 31, 2010 | Not classified | Z-1593-2010 | Process control | One lot of 13 mm medium distal ring centralizers and 14 mm large distal ring centralizer have been labeled incorrectly. The size 14 Large centralizers have been labeled as size 13 Medium centralizers and size 13 Medium centralizers have… |
| Mar 31, 2010 | Not classified | Z-1594-2010 | Process control | One lot of 13 mm medium distal ring centralizers and 14 mm large distal ring centralizer have been labeled incorrectly. The size 14 Large centralizers have been labeled as size 13 Medium centralizers and size 13 Medium centralizers have… |
| Mar 29, 2010 | Not classified | Z-1601-2010 | Error in labeling | Stryker became aware that device labels have incorrectly printed manufacture dates and thus incorrect expiration dates on the product label. |
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 Exeter Il Distal Centralizer is intended to be used to centralize the femoral stem within the intramedullary canal. The Distal Centralizer 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/K974054 · printed Nov 5, 2026
Cite this page
510(k) Report. “K974054: Distal Centralizer, Exeter II Hip System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K974054
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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