510(k) · Cleared
ClearedReliance Long Stem Femoral Components
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 Jun 26, 1998 as substantially equivalent to K936126 (Howmedica, Inc., 1994) and 2 other predicates after a 115-day review. Its family tree reaches back 2 generations to 1994.
- Decided
- Jun 26, 1998
- Review
- 115 days
- Class
- Class II
- Product code
- JDI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K921308 (1994). 7 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K921308 | HG Multilock Hip Prosthesis W/ TI-Nidium | Zimmer, Inc. | 1994 | 1 |
| −1 | K972893 | Partnership Revision Femoral Stems | Howmedica Corp. | 1997 | — |
| 0 (this device) | K980813 | Reliance Long Stem Femoral Components | Howmedica, Inc. | 1998 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 0 |
| 1995 | 2 | 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 |
|---|---|---|---|
| * | K936126 | Howmedics DRG Femoral ComponentSummary page 1…moral components is based on an equivalence in intended use, materials, design, and relative indications and contraindications to Howmedica's Reliance® Total Hip system (K936126), Partnership Revision Femoral Components (K972893) and Modular Replacement System (K952970). Testing has demonstrated that the… | 1994 |
| * | K972893 | Partnership Revision Femoral StemsSummary page 1…nded use, materials, design, and relative indications and contraindications to Howmedica's Reliance® Total Hip system (K936126), Partnership Revision Femoral Components (K972893) and Modular Replacement System (K952970). Testing has demonstrated that the fatigue load carrying capacity of the Reliance® Lon… | 1997 |
| * | K952970 | Howmedica Femoral & Proximal Tibial Modular Replacement SytesmSummary page 1…indications and contraindications to Howmedica's Reliance® Total Hip system (K936126), Partnership Revision Femoral Components (K972893) and Modular Replacement System (K952970). Testing has demonstrated that the fatigue load carrying capacity of the Reliance® Long Stem Femoral Components exceeds the min… | 1996 |
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?
- The line of descent spans 4 years and passes through 3 companies; a new generation was cleared every 3.7 years on median.
- 3 of the 7 ancestors have a recall of any class.
- 3 other devices also cite its predicate K936126.
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 Reliance Long Stem Femoral components are intended to be used in primary or revision surgery for patients diagnosed with rheumatoid arthritis, osteoarthritis, avascular necrosis, metastatic lesions, or traumatic femoral fractures. These femoral components are intended to be used with Howmedica's V40™ femoral heads, Unipolar or Bipolar components, and acetabular components.
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/K980813 · printed Nov 4, 2026
Cite this page
510(k) Report. “K980813: Reliance Long Stem Femoral Components.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K980813
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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