510(k) · Cleared
ClearedAvalon Cup System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Orthopedic Source, Inc. · JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Cleared on Dec 27, 2001 after a 192-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 71 later devices descend from it.
- Decided
- Dec 27, 2001
- Review
- 192 days
- Class
- Class II
- Product code
- JDI
- Recalls
- None
- Predicates
- 0
71 later devices descend from it, 1 citing it directly.
- This deviceK011887 Avalon Cup SystemOrthopedic Source, Inc. · 2001
- Descendant · cites it directly · 70 of its ownK022711 Modification to Avalon Cup SystemOrthopedic Source, Inc. · 2002
- Descendant · 2 generations on · 69 of its ownK060635 Consensus Acetabular Shell SystemHayes Medical, Inc. · 2006
- Descendant · 3 generations on · 53 of its ownK112802 Pipeline Total Hip SystemPipeline Orthopedics · 2012
- Descendant · 3 generations on · 33 of its ownK102399 Consensus Taperset Hip SystemConsensus Orthopedics, Inc. · 2010
- Descendant · 3 generations on · 21 of its ownK141043 CS2 Multi-Hole Acetabular ShellConsensus Orthopedics, Inc. · 2014
Showing 5 of 71 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 71 · See all- K022711Modification to Avalon Cup SystemOrthopedic Source, Inc. · 2002 · cites it directly70descendants
- K060635Consensus Acetabular Shell SystemHayes Medical, Inc. · 2006 · 2 generations on69descendants
- K112802Pipeline Total Hip SystemPipeline Orthopedics · 2012 · 3 generations on53descendants
- K102399Consensus Taperset Hip SystemConsensus Orthopedics, Inc. · 2010 · 3 generations on33descendants
- K141043CS2 Multi-Hole Acetabular ShellConsensus Orthopedics, Inc. · 2014 · 3 generations on21descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K011887 | Avalon Cup System | Orthopedic Source, Inc. | 2001 | — |
| +1 | K022711 | Modification to Avalon Cup System | Orthopedic Source, Inc. | 2002 | — |
| +2 | K060635 | Consensus Acetabular Shell System | Hayes Medical, Inc. | 2006 | — |
| +3 | K112802 | Pipeline Total Hip System | Pipeline Orthopedics | 2012 | — |
| +3 | K102399 | Consensus Taperset Hip System | Consensus Orthopedics, Inc. | 2010 | — |
| +3 | K141043 | CS2 Multi-Hole Acetabular Shell | Consensus Orthopedics, Inc. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2006 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 7 | 0 |
| 2013 | 5 | 0 |
| 2014 | 2 | 0 |
| 2015 | 3 | 0 |
| 2016 | 2 | 0 |
| 2017 | 5 | 0 |
| 2018 | 2 | 0 |
| 2019 | 5 | 0 |
| 2020 | 2 | 0 |
| 2021 | 3 | 0 |
| 2022 | 8 | 0 |
| 2023 | 9 | 0 |
| 2024 | 4 | 0 |
| 2025 | 4 | 0 |
| 2026 | 5 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (71)
See all 711 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K022711 | Modification to Avalon Cup System | 2002 | 70 |
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?
- Of its descendants, K022711 (Orthopedic Source, Inc., 2002) has gone furthest, with 70 descendants of its own.
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?
Indication: for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following:
1) Non-inflammatory degenerative joint disease including: osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia,
2) Inflammatory degenerative joint disease including rheumatoid arthritis;
3) Correction of functional deformity;
4) Revision procedures where other treatments or devices have failed; and, treatment of nonunion, femoral neck fractures of the proximal femur with head involvement that are unmanageable using other techniques.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K011887 · printed Nov 4, 2026
Cite this page
510(k) Report. “K011887: Avalon Cup System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K011887
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026