510(k) · Cleared
Recalled · Class II · 2019Ascension 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 Jan 12, 2009 as substantially equivalent to K022892 (Ascension Orthopedics, Inc., 2002) and 1 other predicate after a 158-day review. Its family tree reaches back 2 generations to 1997. 2 later devices descend from it. It has been recalled once.
- Decided
- Jan 12, 2009
- Review
- 158 days
- Class
- Class II
- Product code
- KYJ
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 2 generations to K970544 (1997). 3 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK970544 Depuy Dupont Orthopaedics Finger Joint ProsthesisDepuy, Inc. · 1997
- 1 generation backK001922 Depuy Neuflex Pip FingerDepuy, Inc. · 2000
- This deviceK082231 Ascension Silicone PipAscension Orthopedics, Inc. · 2009
- 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 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K970544 | Depuy Dupont Orthopaedics Finger Joint Prosthesis | Depuy, Inc. | 1997 | — |
| −1 | K001922 | Depuy Neuflex Pip Finger | Depuy, Inc. | 2000 | — |
| 0 (this device) | K082231 | Ascension Silicone Pip | Ascension Orthopedics, Inc. | 2009 | — |
| +1 | K233670 | Ascension Silicone MCP; Ascension Silicone PIP | Ascension Orthopedics, Inc. | 2023 | — |
| +1 | K220142 | BRM Digitalis Spacer | Brm Extremities Srl | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 1…is, finger, constrained, polymer CLASSIFICATION: 21 CFR 888.3230 PRODUCT CODE: KYJ PANEL: Orthopedic PREDICATE DEVICES: K022892 - Ascension Silicone MCP K001922 - DePuy Neuflex PIP Finger DEVICE DESCRIPTION: The Ascension® Silicone PIP is a single componen… | 2002 |
| * | K001922 | Depuy Neuflex Pip FingerSummary page 1…CLASSIFICATION: 21 CFR 888.3230 PRODUCT CODE: KYJ PANEL: Orthopedic PREDICATE DEVICES: K022892 - Ascension Silicone MCP K001922 - DePuy Neuflex PIP Finger DEVICE DESCRIPTION: The Ascension® Silicone PIP is a single component silicone spacer consisting of a… | 2000 |
What descends from it? (2)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 4, 2019 | Class II | Z-0691-2020 | Labeling mix-ups | Silicone PIP Implant mislabeled as a size 1 implant on the outer packaging when in fact the package contained a size 0 implant |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 2 companies; a new generation was cleared every 8.4 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K233670 (Ascension Orthopedics, Inc., 2023) has gone furthest, with 0 descendants of its own.
- 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. 2009, 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 indications for use of the Ascension Silicone PIP are for cementless
replacement of the proximal interphalangeal joint in patients with advanced
osteoarthritis, post-traumatic arthritis and rheumatoid arthritis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082231 · printed Nov 5, 2026
Cite this page
510(k) Report. “K082231: 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/K082231
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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