510(k) · Cleared
Recalled · Class II · 2012Depuy Luster Stem
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
DePuy Orthopaedics, Inc. · JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Cleared on Nov 25, 1998 as substantially equivalent to K942370 (Depuy, Inc., 1994) and 3 other predicates after a 78-day review. Its family tree reaches back 3 generations to 1989. It has been recalled 10 times.
- Decided
- Nov 25, 1998
- Review
- 78 days
- Class
- Class II
- Product code
- JDI
- Recalls
- 10
- Predicates
- 4
Its longest line of descent runs back 3 generations to K891454 (1989). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK891454 Exeter II Total Hip SystemHowmedica Corp. · 1989
- 2 generations backK974054 Distal Centralizer, Exeter II Hip SystemHowmedica, Inc. · 1997 · Recalled
- 1 generation backK980843 Exeter Intramedullary Bone PlugHowmedica, Inc. · 1998
- This deviceK983136 Depuy Luster StemDePuy Orthopaedics, Inc. · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K891454 | Exeter II Total Hip System | Howmedica Corp. | 1989 | — |
| −2 | K974054 | Distal Centralizer, Exeter II Hip System | Howmedica, Inc. | 1997 | 3 |
| −1 | K980843 | Exeter Intramedullary Bone Plug | Howmedica, Inc. | 1998 | — |
| 0 (this device) | K983136 | Depuy Luster Stem | DePuy Orthopaedics, Inc. | 1998 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 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? (4)
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 |
|---|---|---|---|
| * | K942370 | Depuy Cemented Hip ProsthesisSummary page 1…ON: Class II per 888.3350, Hip joint metal/polymer semi- constrained cemented prosthesis DEVICE CODE: JDI EQUIVALENT DEVICES: DePuy Cemented Hip Prosthesis (Endurance)(K942370) CPT Hip Prosthesis (K960658) Exeter Total Hip System (K974054, K980843) DEVICE DESCRIPTION AND INTENDED USE: The DePuy Luster… | 1994 |
| * | K960658 | Collarless Polished Taper Hip ProsthesisSummary page 1…joint metal/polymer semi- constrained cemented prosthesis DEVICE CODE: JDI EQUIVALENT DEVICES: DePuy Cemented Hip Prosthesis (Endurance)(K942370) CPT Hip Prosthesis (K960658) Exeter Total Hip System (K974054, K980843) DEVICE DESCRIPTION AND INTENDED USE: The DePuy Luster Stem is a polished, distally… | 1996 |
| * | K974054 | Distal Centralizer, Exeter II Hip SystemSummary page 1…ined cemented prosthesis DEVICE CODE: JDI EQUIVALENT DEVICES: DePuy Cemented Hip Prosthesis (Endurance)(K942370) CPT Hip Prosthesis (K960658) Exeter Total Hip System (K974054, K980843) DEVICE DESCRIPTION AND INTENDED USE: The DePuy Luster Stem is a polished, distally tapered femoral stem with a proxim… | 1997 |
| * | K980843 | Exeter Intramedullary Bone PlugSummary page 1…nted prosthesis DEVICE CODE: JDI EQUIVALENT DEVICES: DePuy Cemented Hip Prosthesis (Endurance)(K942370) CPT Hip Prosthesis (K960658) Exeter Total Hip System (K974054, K980843) DEVICE DESCRIPTION AND INTENDED USE: The DePuy Luster Stem is a polished, distally tapered femoral stem with a proximal anteri… | 1998 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 16, 2012 | Class II | Z-1921-2012 | Device Design | DePuy Orthopaedics, Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femoral Hip Stems and the ULTIMA LX Cemented Polished Femoral Hip Stems that were implanted with any metal-on-metal (MoM) articulation (including a… |
| May 16, 2012 | Class II | Z-1920-2012 | Device Design | DePuy Orthopaedics, Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femoral Hip Stems and the ULTIMA LX Cemented Polished Femoral Hip Stems that were implanted with any metal-on-metal (MoM) articulation (including a… |
| May 16, 2012 | Class II | Z-1915-2012 | Device Design | DePuy Orthopaedics, Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femoral Hip Stems and the ULTIMA LX Cemented Polished Femoral Hip Stems that were implanted with any metal-on-metal (MoM) articulation (including a… |
| May 16, 2012 | Class II | Z-1917-2012 | Device Design | DePuy Orthopaedics, Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femoral Hip Stems and the ULTIMA LX Cemented Polished Femoral Hip Stems that were implanted with any metal-on-metal (MoM) articulation (including a… |
| May 16, 2012 | Class II | Z-1924-2012 | Device Design | DePuy Orthopaedics, Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femoral Hip Stems and the ULTIMA LX Cemented Polished Femoral Hip Stems that were implanted with any metal-on-metal (MoM) articulation (including a… |
| May 16, 2012 | Class II | Z-1922-2012 | Device Design | DePuy Orthopaedics, Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femoral Hip Stems and the ULTIMA LX Cemented Polished Femoral Hip Stems that were implanted with any metal-on-metal (MoM) articulation (including a… |
| May 16, 2012 | Class II | Z-1918-2012 | Device Design | DePuy Orthopaedics, Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femoral Hip Stems and the ULTIMA LX Cemented Polished Femoral Hip Stems that were implanted with any metal-on-metal (MoM) articulation (including a… |
| May 16, 2012 | Class II | Z-1919-2012 | Device Design | DePuy Orthopaedics, Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femoral Hip Stems and the ULTIMA LX Cemented Polished Femoral Hip Stems that were implanted with any metal-on-metal (MoM) articulation (including a… |
| May 16, 2012 | Class II | Z-1916-2012 | Device Design | DePuy Orthopaedics, Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femoral Hip Stems and the ULTIMA LX Cemented Polished Femoral Hip Stems that were implanted with any metal-on-metal (MoM) articulation (including a… |
| Feb 22, 2005 | Not classified | Z-1549-05 | Other | Linvatec has determined there is a possibility the pouch Tyvek header to foil longitudinal seal was not properly sealed by Bemis Flexible Packaging, in all pouches, prior to sterilization by Linvatec. Therefore there is a potential for… |
The 5 latest of 10 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 9 years and passes through 3 companies; a new generation was cleared every 6 months on median.
- 3 of the 7 ancestors have a recall of any class.
- 2 other devices also cite its predicate K942370.
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 DePuy Luster Stem is indicated for cemented use as the femoral component in total hip arthroplasty for replacing the hip joint of a patient whose hip joint has been damaged by degenerative joint disease, fracture, or the failure of a previous arthroplasty.
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/K983136 · printed Nov 6, 2026
Cite this page
510(k) Report. “K983136: Depuy Luster Stem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K983136
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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