510(k) · Cleared
ClearedAscension Sillicone MCP
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ascension Orthopedics, Inc. · KYJ Prosthesis, Finger, Constrained, Polymer
Cleared on Nov 25, 2002 as substantially equivalent to K970544 (Depuy, Inc., 1997) after an 87-day review. Its family tree reaches back 1 generation to 1997. 3 later devices descend from it.
- Decided
- Nov 25, 2002
- Review
- 87 days
- Class
- Class II
- Product code
- KYJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K970544 (1997). 3 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK970544 Depuy Dupont Orthopaedics Finger Joint ProsthesisDepuy, Inc. · 1997
- This deviceK022892 Ascension Sillicone MCPAscension Orthopedics, Inc. · 2002
- Descendant · cites it directly · 2 of its ownK082231 Ascension Silicone PipAscension Orthopedics, Inc. · 2009 · Recalled
- Descendant · cites it directly · 0 of its ownK233670 Ascension Silicone MCP; Ascension Silicone PIPAscension Orthopedics, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK220142 BRM Digitalis SpacerBrm Extremities Srl · 2023
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K970544 | Depuy Dupont Orthopaedics Finger Joint Prosthesis | Depuy, Inc. | 1997 | — |
| 0 (this device) | K022892 | Ascension Sillicone MCP | Ascension Orthopedics, Inc. | 2002 | — |
| +1 | K082231 | Ascension Silicone Pip | Ascension Orthopedics, Inc. | 2009 | 1 |
| +1 | K233670 | Ascension Silicone MCP; Ascension Silicone PIP | Ascension Orthopedics, Inc. | 2023 | — |
| +1 | K220142 | BRM Digitalis Spacer | Brm Extremities Srl | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2023 | 2 | 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 KYJ? 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 KYJ device
- #1 K233670 Ascension Silicone MCP; Ascension Silicone PIPscore 7.1 · 3 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 |
|---|---|---|---|
| * | K970544 | Depuy Dupont Orthopaedics Finger Joint ProsthesisSummary page 1…(Class 11) PRODUCT CODE: 87 KYJ PANEL: Orthopedic Devices PREDLCATE DEVICE: The DePuy Silicone MCP (K970544),which was determined by the FDA tu be substiintially cquivalent to the Sutter Avanta MCP Joint Prosthesis and the Dow Corning Wr… | 1997 |
What descends from it? (3)
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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All KYJ devicesKYJ Prosthesis, Finger, Constrained, Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KYJ
2in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · KYJ
Too few KYJ 510(k)s in any year since 2007 to give a median.
Recalls per year · KYJ
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KYJ
32in 2025
MAUDE reports naming product code KYJ, 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 | 0 | — | 0 | 9 |
| 2008 | 0 | — | 0 | 15 |
| 2009 | 2 | — | 0 | 35 |
| 2010 | 0 | — | 0 | 9 |
| 2011 | 0 | — | 0 | 11 |
| 2012 | 0 | — | 0 | 25 |
| 2013 | 0 | — | 0 | 11 |
| 2014 | 0 | — | 0 | 14 |
| 2015 | 1 | — | 0 | 18 |
| 2016 | 0 | — | 2 | 6 |
| 2017 | 0 | — | 0 | 14 |
| 2018 | 0 | — | 0 | 11 |
| 2019 | 0 | — | 1 | 26 |
| 2020 | 0 | — | 0 | 48 |
| 2021 | 0 | — | 0 | 45 |
| 2022 | 1 | — | 0 | 39 |
| 2023 | 2 | — | 0 | 24 |
| 2024 | 0 | — | 0 | 29 |
| 2025 | 0 | — | 0 | 32 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Ascension® Silicone MCP is intended for cementless replacement of the metacarpophalangeal (MCP) joint of the finger where disabled by rheumatoid, degenerative, or traumatic arthritis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022892 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022892: Ascension Sillicone MCP.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022892
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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