510(k) · Cleared
ClearedModification to Depuy Neuflex Pip Finger
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
DePuy Orthopaedics, Inc. · KYJ Prosthesis, Finger, Constrained, Polymer
Cleared on Feb 9, 2009 as substantially equivalent to K001922 (Depuy, Inc., 2000) and 1 other predicate after a 112-day review. Its family tree reaches back 2 generations to 1997. 1 later device descends from it.
- Decided
- Feb 9, 2009
- Review
- 112 days
- Class
- Class II
- Product code
- KYJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K970544 (1997). 1 later device descends from it, 1 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 deviceK083107 Modification to Depuy Neuflex Pip FingerDePuy Orthopaedics, Inc. · 2009
- Descendant · cites it directly · 0 of its ownK211385 KeriFlex® MCP and PIP Finger Joint ProsthesesKeri Medical SA · 2022
Most influential descendants
Showing 1 of 1 · See all- K211385KeriFlex® MCP and PIP Finger Joint ProsthesesKeri Medical SA · 2022 · cites it directly0descendants
View 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) | K083107 | Modification to Depuy Neuflex Pip Finger | DePuy Orthopaedics, Inc. | 2009 | — |
| +1 | K211385 | KeriFlex® MCP and PIP Finger Joint Prostheses | Keri Medical SA | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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 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? (3)
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 |
|---|---|---|---|
| * | K001922 | Depuy Neuflex Pip Finger | 2000 |
| * | K970544 | Depuy Dupont Orthopaedics Finger Joint ProsthesisSummary page 1…Product Code: 87 KYJ SubstntialEquivlenceDePuy NeuFlex PIP Finger (KOO 1922) NeuFlex MCP Finger Prosthesis (K970544) Dow Corning Wright Swanson Finger Implant Indications for Use: The Modified DePuy NeuFlex PI… | 1997 |
| * | — | Dow Corning Wright Swanson Finger Implant Named without a submission number |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K211385 | KeriFlex® MCP and PIP Finger Joint Prostheses | 2022 | 0 |
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 12 years and passes through 2 companies; a new generation was cleared every 8.4 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K211385 (Keri Medical SA, 2022) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K001922.
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 DePuy NeuFlex PIP Finger Prosthesis is indicated for cementless replacement of the proximal interphalangeal (PIP) joints of the finger where disabled by rheumatoid, degenerative or traumatic arthritis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083107 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083107: Modification to Depuy Neuflex Pip Finger.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083107
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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