510(k) · Cleared
Cleared8MM 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 1, 1999 as substantially equivalent to K961890 (Encore Orthopedics, Inc., 1996) after a 50-day review. Its family tree reaches back 2 generations to 1995. 3 later devices descend from it.
- Decided
- Jun 1, 1999
- Review
- 50 days
- Class
- Class II
- Product code
- JDI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K952191 (1995). 3 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK952191 Forged Cemented StemEncore Orthopedics, Inc. · 1995
- 1 generation backK961890 Foundation 9MM Forged Cemented StemEncore Orthopedics, Inc. · 1996 · Recalled
- This deviceK991227 8MM Forged Cemented StemEncore Orthopedics, Inc. · 1999
- Descendant · cites it directly · 1 of its ownK031165 Plus Orthopedics Cemented Hip StemPlus Orthopedics · 2003
- Descendant · 2 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
Most influential descendants
Showing 3 of 3 · See all- K031165Plus Orthopedics Cemented Hip StemPlus Orthopedics · 2003 · cites it directly1descendant
- K123598Smith & Nephew, Inc. Hip System InstrumentationSmith & Nephew, Inc. · 2013 · 2 generations on0descendants
- K121024Linear Porous Coated Hip Stem, Size 5; Revelation Hip Stem, Size 8; Foundation Porous…Encore Medical L.P. · 2012 · cites it directly0descendants
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) | K991227 | 8MM Forged Cemented Stem | Encore Orthopedics, Inc. | 1999 | — |
| +1 | K031165 | Plus Orthopedics Cemented Hip Stem | Plus Orthopedics | 2003 | — |
| +2 | 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 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K961890 | Foundation 9MM Forged Cemented Stem Our OCR of the scanned summary read K961809, FDA’s number for She-LI Tens Stimulator Model SL-101 RX (Medi Consultants, Inc.). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “9mm Forged Cemented Stem”. | 1996 |
What descends from it? (3)
2 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)
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 1 company; a new generation was cleared every 3.0 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K031165 (Plus Orthopedics, 2003) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K961890.
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 indications for use of the Foundation 8mm cemented total hip replacement prosthesis include: degenerative joint disease including osteoarthritis and avascular necrosis; rheumatoid arthritis; correction of functional deformity; revision procedures where other treatments or 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
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/K991227 · printed Nov 5, 2026
Cite this page
510(k) Report. “K991227: 8MM 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/K991227
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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