510(k) · Cleared
ClearedUnicompartmental Patellofemoral Prosthesis (Upp) Cemented
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Walter Abendschein, M.D. · KRR Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer
Cleared on Jun 23, 2000 after a 101-day review. FDA has not posted a summary or statement for it, so its predicates are not known.
- Decided
- Jun 23, 2000
- Review
- 101 days
- Class
- Class II
- Product code
- KRR
- Recalls
- None
- Predicates
- 0
FDA has not posted a summary or statement for it, so its predicates are not known.
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KRR? 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 KRR device
- #1 K231253 Overture Orthopaedics Patellofemoral Systemscore 5.6 · 1 generation · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
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.
How does its category compare?
All KRR devicesKRR Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KRR
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · KRR
116in 2008
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KRR
3in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KRR
36in 2025
MAUDE reports naming product code KRR, 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 | 2 | — | 0 | 0 |
| 2008 | 3 | 116 | 0 | 0 |
| 2009 | 0 | — | 0 | 12 |
| 2010 | 0 | — | 0 | 6 |
| 2011 | 0 | — | 0 | 3 |
| 2012 | 1 | — | 0 | 9 |
| 2013 | 1 | — | 1 | 9 |
| 2014 | 0 | — | 0 | 26 |
| 2015 | 1 | — | 0 | 18 |
| 2016 | 1 | — | 1 | 14 |
| 2017 | 0 | — | 2 | 15 |
| 2018 | 1 | — | 0 | 14 |
| 2019 | 0 | — | 0 | 16 |
| 2020 | 1 | — | 0 | 6 |
| 2021 | 1 | — | 0 | 8 |
| 2022 | 1 | — | 3 | 9 |
| 2023 | 1 | — | 0 | 12 |
| 2024 | 0 | — | 0 | 25 |
| 2025 | 0 | — | 0 | 36 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K000827 · printed Nov 5, 2026
Cite this page
510(k) Report. “K000827: Unicompartmental Patellofemoral Prosthesis (Upp) Cemented.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K000827
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026