510(k) · Cleared
ClearedAscension Silicone MCP; Ascension Silicone PIP
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 Dec 14, 2023 as substantially equivalent to K022892 (Ascension Orthopedics, Inc., 2002) and 1 other predicate after a 29-day review. Its family tree reaches back 3 generations to 1997.
- Decided
- Dec 14, 2023
- Review
- 29 days
- Class
- Class II
- Product code
- KYJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K970544 (1997). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK970544 Depuy Dupont Orthopaedics Finger Joint ProsthesisDepuy, Inc. · 1997
- 2 generations backK001922 Depuy Neuflex Pip FingerDepuy, Inc. · 2000
- 1 generation backK082231 Ascension Silicone PipAscension Orthopedics, Inc. · 2009 · Recalled
- This deviceK233670 Ascension Silicone MCP; Ascension Silicone PIPAscension Orthopedics, Inc. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K970544 | Depuy Dupont Orthopaedics Finger Joint Prosthesis | Depuy, Inc. | 1997 | — |
| −2 | K001922 | Depuy Neuflex Pip Finger | Depuy, Inc. | 2000 | — |
| −1 | K082231 | Ascension Silicone Pip | Ascension Orthopedics, Inc. | 2009 | 1 |
| 0 (this device) | K233670 | Ascension Silicone MCP; Ascension Silicone PIP | Ascension Orthopedics, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 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 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 K220142 BRM Digitalis Spacerscore 5.7 · 3 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K022892 | Ascension Sillicone MCPSummary page 4…KYJ Regulation 888.3230 - Finger joint polymer constrained prosthesis Classification Class II Primary Predicate Ascension Silicone MCP: K022892 Device Additional Predicate Ascension Silicone PIP: K082231 Device Review Branch Orthopedic Device Description… | 2002 |
| * | K082231 | Ascension Silicone PipSummary page 4…er constrained prosthesis Classification Class II Primary Predicate Ascension Silicone MCP: K022892 Device Additional Predicate Ascension Silicone PIP: K082231 Device Review Branch Orthopedic Device Description The ASCENSION Silicone MCP and PIP implants are anatomically… | 2009 |
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.
What does this lineage say?
- The line of descent spans 26 years and passes through 2 companies; a new generation was cleared every 8.4 years on median.
- 1 of the 4 ancestors has a recall of any class.
- 2 other devices also cite its predicate K022892.
How does its category compare?
All KYJ devicesKYJ Prosthesis, Finger, Constrained, Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
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 PIP implant is intended for cementless
replacement of the proximal interphalangeal joint in patients with
advanced osteoarthritis, post-traumatic arthritis and rheumatoid
arthritis.
The ASCENSION Silicone MCP implant is intended for cementless
replacement of the metacarpophalangeal (MCP) joint of the finger
where disabled by rheumatoid, degenerative or traumatic arthritis.
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/K233670 · printed Nov 5, 2026
Cite this page
510(k) Report. “K233670: Ascension Silicone MCP; Ascension Silicone PIP.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K233670
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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