510(k) · Cleared
ClearedVitality Hip Stem
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Encore Orthopedics, Inc. · JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Cleared on Sep 19, 1996 as substantially equivalent to K952191 (Encore Orthopedics, Inc., 1995) and 2 other predicates after an 80-day review. Its family tree reaches back 2 generations to 1995.
- Decided
- Sep 19, 1996
- Review
- 80 days
- Class
- Class II
- Product code
- JDI
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K952191 (1995). 3 ancestors in all, the oldest K885146 (1989). 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 | K952191 | Forged Cemented Stem | Encore Orthopedics, Inc. | 1995 | — |
| −1 | K961890 | Foundation 9MM Forged Cemented Stem | Encore Orthopedics, Inc. | 1996 | 1 |
| 0 (this device) | K962560 | Vitality Hip Stem | Encore Orthopedics, Inc. | 1996 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K952191 | Forged Cemented StemSummary page 1…r, bipolar and CoCrMo femoral heads. Comparable Features to Predicate Device(s): Features comparable to predicate devices include the Foundation® Forged Cemented Stems (K952191) | Foundation® 9 mm Forged Stems (K961890), CoCrMo substrate, calcar collar, roughened proximal body, modular heads, bipolar and… | 1995 |
| * | K961890 | Foundation 9MM Forged Cemented StemSummary page 1…arable Features to Predicate Device(s): Features comparable to predicate devices include the Foundation® Forged Cemented Stems (K952191) | Foundation® 9 mm Forged Stems (K961890), CoCrMo substrate, calcar collar, roughened proximal body, modular heads, bipolar and unipolar heads. The design is comparable t… | 1996 |
| * | K885146 | CL Universal Hip DeviceSummary page 1…Mo substrate, calcar collar, roughened proximal body, modular heads, bipolar and unipolar heads. The design is comparable to the predicate device the Lima Universal Stem(K885146, K910830). Test Results: Laboratory testing of the Morse type taper was conducted. Theoretical testing of the maximum stresses w… | 1989 |
| Kept off the family tree | K910830 | FDA’s K910830 is Invalift Our OCR of the scanned summary read K910830, FDA’s number for Invalift (American Invalift Corp.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Lima Universal Stem”. Kept off the family tree. Summary page 1…ate, calcar collar, roughened proximal body, modular heads, bipolar and unipolar heads. The design is comparable to the predicate device the Lima Universal Stem(K885146, K910830). Test Results: Laboratory testing of the Morse type taper was conducted. Theoretical testing of the maximum stresses was compar… | 1992 |
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 1 year and passes through 1 company; a new generation was cleared every 11 months on median.
- 1 of the 3 ancestors has a recall of any class.
- 3 other devices also cite its predicate K952191.
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 Vitality Hip stem is intended for treatment of patients who are candidates for total or hemi-hip arthroplasty. The indications for use of the total hip replacement prosthesis include: noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis; rheumatoid arthritis; correction of functional deformity; revision procedures where other treatments where devices have failed; and treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement, which is unmanageable using other techniques.
It is intended to be used with cement with acetabular components or with unipolar, bipolar and CoCrMo femoral heads.
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/K962560 · printed Nov 4, 2026
Cite this page
510(k) Report. “K962560: Vitality Hip Stem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K962560
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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