510(k) · Cleared
Recalled · Class II · 2012Ultima and Ultima LX Cemented Femoral Stem
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Johnson & Johnson Professionals, Inc. · JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Cleared on Sep 11, 1997 as substantially equivalent to K924379 (Johnson & Johnson Orthopaedics, Inc., 1993) after a 73-day review. Its family tree reaches back 1 generation to 1993. 1 later device descends from it. It has been recalled 9 times.
- Decided
- Sep 11, 1997
- Review
- 73 days
- Class
- Class II
- Product code
- JDI
- Recalls
- 9
- Predicates
- 1
Its longest line of descent runs back 1 generation to K924379 (1993). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK924379 Ultima (TM) Total Hip System Cemented Femoral StemJohnson & Johnson Orthopaedics, Inc. · 1993
- This deviceK972435 Ultima and Ultima LX Cemented Femoral StemJohnson & Johnson Professionals, Inc. · 1997
- Descendant · cites it directly · 0 of its ownK982812 G2 Total Hip System Femoral Stem (11/13 Taper)Johnson & Johnson Professionals, Inc. · 1998
Most influential descendants
Showing 1 of 1 · See all- K982812G2 Total Hip System Femoral Stem (11/13 Taper)Johnson & Johnson Professionals, Inc. · 1998 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K924379 | Ultima (TM) Total Hip System Cemented Femoral Stem | Johnson & Johnson Orthopaedics, Inc. | 1993 | — |
| 0 (this device) | K972435 | Ultima and Ultima LX Cemented Femoral Stem | Johnson & Johnson Professionals, Inc. | 1997 | — |
| +1 | K982812 | G2 Total Hip System Femoral Stem (11/13 Taper) | Johnson & Johnson Professionals, Inc. | 1998 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 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 |
|---|---|---|---|
| * | K924379 | Ultima (TM) Total Hip System Cemented Femoral StemSummary page 1…stantially equivalent and identical in material and in function to the ULTIMA Total Hip System Cemented Femoral Stem cleared for marketing under premarket notification #K 924379 (February 12, 1993). The subject device is composed of similar materials to the predicate device mentioned above. Further, the i… | 1993 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K982812 | G2 Total Hip System Femoral Stem (11/13 Taper) | 1998 | 0 |
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-1914-2012 | 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-1912-2012 | 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-1907-2012 | 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-1908-2012 | 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-1910-2012 | 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-1913-2012 | 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-1906-2012 | 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-1911-2012 | 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-1909-2012 | 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… |
The 5 latest of 9 recalls; the web page lists all.
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 ULTIMA and ULTIMA LX Femoral Hip Stem is indicated for use in total or partial
hip replacement procedures for patients suffering severe pain and disability due to
structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic
arthritis, collagen disorders, avascular necrosis, traumatic and non-union of femoral
fractures. Use of the prosthesis is also indicated for patients with congenital hip
dysplasia, protrusio acetabuli, slipped capital epiphysis, and disability due to previous
fusion, where bone stock is inadequate for other reconstruction techniques.
The ULTIMA and ULTIMA LX Cemented Femoral stem is indicated for use only with
PMMA 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/K972435 · printed Nov 6, 2026
Cite this page
510(k) Report. “K972435: Ultima and Ultima LX Cemented Femoral Stem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K972435
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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