510(k) · Cleared
Recalled · 2011Foundation 9MM Forged Cemented 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 Jun 14, 1996 as substantially equivalent to K952191 (Encore Orthopedics, Inc., 1995) after a 30-day review. Its family tree reaches back 1 generation to 1995. 5 later devices descend from it. It has been recalled once.
- Decided
- Jun 14, 1996
- Review
- 30 days
- Class
- Class II
- Product code
- JDI
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K952191 (1995). 5 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK952191 Forged Cemented StemEncore Orthopedics, Inc. · 1995
- This deviceK961890 Foundation 9MM Forged Cemented StemEncore Orthopedics, Inc. · 1996
- Descendant · cites it directly · 3 of its ownK991227 8MM Forged Cemented StemEncore Orthopedics, Inc. · 1999
- Descendant · 2 generations on · 1 of its ownK031165 Plus Orthopedics Cemented Hip StemPlus Orthopedics · 2003
- Descendant · 3 generations on · 0 of its ownK123598 Smith & Nephew, Inc. Hip System InstrumentationSmith & Nephew, Inc. · 2013 · Recalled
- Descendant · cites it directly · 0 of its ownK121024 Linear Porous Coated Hip Stem, Size 5; Revelation Hip Stem, Size 8…Encore Medical L.P. · 2012
- Descendant · cites it directly · 0 of its ownK962560 Vitality Hip StemEncore Orthopedics, Inc. · 1996
Most influential descendants
Showing 5 of 5 · See all- K9912278MM Forged Cemented StemEncore Orthopedics, Inc. · 1999 · cites it directly3descendants
- K031165Plus Orthopedics Cemented Hip StemPlus Orthopedics · 2003 · 2 generations on1descendant
- K123598Smith & Nephew, Inc. Hip System InstrumentationSmith & Nephew, Inc. · 2013 · 3 generations on0descendants
- K121024Linear Porous Coated Hip Stem, Size 5; Revelation Hip Stem, Size 8; Foundation Porous…Encore Medical L.P. · 2012 · cites it directly0descendants
- K962560Vitality Hip StemEncore Orthopedics, Inc. · 1996 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K952191 | Forged Cemented Stem | Encore Orthopedics, Inc. | 1995 | — |
| 0 (this device) | K961890 | Foundation 9MM Forged Cemented Stem | Encore Orthopedics, Inc. | 1996 | — |
| +1 | K991227 | 8MM Forged Cemented Stem | Encore Orthopedics, Inc. | 1999 | — |
| +2 | K031165 | Plus Orthopedics Cemented Hip Stem | Plus Orthopedics | 2003 | — |
| +3 | K123598 | Smith & Nephew, Inc. Hip System Instrumentation | Smith & Nephew, Inc. | 2013 | 2 |
| +1 | K121024 | Linear Porous Coated Hip Stem, Size 5; Revelation Hip Stem, Size 8; Foundation… | Encore Medical L.P. | 2012 | — |
| +1 | K962560 | Vitality Hip Stem | Encore Orthopedics, Inc. | 1996 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2003 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 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 |
|---|---|---|---|
| * | K952191 | Forged Cemented StemSummary page 2…omparable Features to Predicate Device(s): Features comparable to predicate devices include the Foundation® Forged Cemented Stems approved for commercial distribution in K952191, CoCrMo substrate, distal femoral canal centralizer, proximal cement spacers, calcar collar, proximal ribs on body, roughened pro… | 1995 |
What descends from it? (5)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 17, 2011 | Not classified | Z-0418-2012 | Packaging | The sterility has the potential to be compromised. |
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 Foundation 9 mm Forged Cemented 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 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/K961890 · printed Nov 5, 2026
Cite this page
510(k) Report. “K961890: Foundation 9MM Forged Cemented Stem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K961890
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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