510(k) · Cleared
ClearedCemented Calcar Replacement 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 Feb 19, 1997 as substantially equivalent to K922503 (Howmedica Corp., 1992) and 2 other predicates after an 82-day review. Its family tree reaches back 1 generation to 1990.
- Decided
- Feb 19, 1997
- Review
- 82 days
- Class
- Class II
- Product code
- JDI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K902712 (1990). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK902712 Osteonics PS Head and Neck Hip Stem SeriesOsteonics Corp. · 1990
- This deviceK964795 Cemented Calcar Replacement Femoral StemJohnson & Johnson Professionals, Inc. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K902712 | Osteonics PS Head and Neck Hip Stem Series | Osteonics Corp. | 1990 | — |
| 0 (this device) | K964795 | Cemented Calcar Replacement Femoral Stem | Johnson & Johnson Professionals, Inc. | 1997 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 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? (3)
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 |
|---|---|---|---|
| * | K922503 | Howmedica (R) HNR SystemSummary page 1…Calcar Replacement Femoral Stem is substantially equivalent in function to both the Howmedica HNR with Porus Coating, cleared for marketing under premarket notification #K922503 (September 21, 1992) and the Osteonics OmniFit Head/Neck Stem, cleared for marketing under premarket notification #K902712 (Augus… | 1992 |
| * | K902712 | Osteonics PS Head and Neck Hip Stem SeriesSummary page 1…ed for marketing under premarket notification #K922503 (September 21, 1992) and the Osteonics OmniFit Head/Neck Stem, cleared for marketing under premarket notification #K902712 (August 9, 1990). Further, the Cemented Calcar Replacement Femoral Stem is substantially equivalent in material and design to the… | 1990 |
| * | K952859 | Ultima Cemented Long Stem Femoral ComponentSummary page 1…em is substantially equivalent in material and design to the ULTIMA Cemented Long Stem Femoral Component, previously cleared for marketing under premarket notification #K 952859 (January 31, 1996). The subject device is composed of similiar materials to the predicate devices mentioned above. Further, the… | 1996 |
| † | K924379 | Ultima (TM) Total Hip System Cemented Femoral Stem | 1993 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- None of the 3 ancestors has a recall.
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 Total Hip System - Cemented Calcar Replacement Femoral Stem is indicated for use in total, partial, or revision hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint form rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, traumatic femoral fractures, and nonunion of femoral fractures. Use of the prothesis is also indicated for…
Read the full statement (105 words)
The Ultima Total Hip System - Cemented Calcar Replacement Femoral Stem is indicated for use in total, partial, or revision hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint form rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, traumatic femoral fractures, and nonunion of femoral fractures. Use of the prothesis is also indicated for patients with congenital hip dysplasia, profrusio acetabuli, slipped capital femoral epiphysis, and disability due to previous fusion, where bone stock is inadequate for other reconstructive techniques.
The Ultima Cemented Calcar Replacement 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/K964795 · printed Nov 4, 2026
Cite this page
510(k) Report. “K964795: Cemented Calcar Replacement Femoral Stem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K964795
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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