510(k) · Cleared
ClearedDepuy Neuflex Pip Finger
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Depuy, Inc. · KYJ Prosthesis, Finger, Constrained, Polymer
Cleared on Aug 29, 2000 as substantially equivalent to K970544 (Depuy, Inc., 1997) after a 67-day review. Its family tree reaches back 1 generation to 1997. 5 later devices descend from it.
- Decided
- Aug 29, 2000
- Review
- 67 days
- Class
- Class II
- Product code
- KYJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K970544 (1997). 5 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK970544 Depuy Dupont Orthopaedics Finger Joint ProsthesisDepuy, Inc. · 1997
- This deviceK001922 Depuy Neuflex Pip FingerDepuy, Inc. · 2000
- Descendant · cites it directly · 2 of its ownK082231 Ascension Silicone PipAscension Orthopedics, Inc. · 2009 · Recalled
- Descendant · cites it directly · 1 of its ownK083107 Modification to Depuy Neuflex Pip FingerDePuy Orthopaedics, Inc. · 2009
- Descendant · 2 generations on · 0 of its ownK233670 Ascension Silicone MCP; Ascension Silicone PIPAscension Orthopedics, Inc. · 2023
- Descendant · 2 generations on · 0 of its ownK220142 BRM Digitalis SpacerBrm Extremities Srl · 2023
- Descendant · 2 generations on · 0 of its ownK211385 KeriFlex® MCP and PIP Finger Joint ProsthesesKeri Medical SA · 2022
Most influential descendants
Showing 5 of 5 · See all- K082231Ascension Silicone PipAscension Orthopedics, Inc. · 2009 · cites it directly2descendants
- K083107Modification to Depuy Neuflex Pip FingerDePuy Orthopaedics, Inc. · 2009 · cites it directly1descendant
- K233670Ascension Silicone MCP; Ascension Silicone PIPAscension Orthopedics, Inc. · 2023 · 2 generations on0descendants
- K220142BRM Digitalis SpacerBrm Extremities Srl · 2023 · 2 generations on0descendants
- K211385KeriFlex® MCP and PIP Finger Joint ProsthesesKeri Medical SA · 2022 · 2 generations on0descendants
View 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) | K001922 | Depuy Neuflex Pip Finger | Depuy, Inc. | 2000 | — |
| +1 | K082231 | Ascension Silicone Pip | Ascension Orthopedics, Inc. | 2009 | 1 |
| +1 | K083107 | Modification to Depuy Neuflex Pip Finger | DePuy Orthopaedics, Inc. | 2009 | — |
| +2 | K233670 | Ascension Silicone MCP; Ascension Silicone PIP | Ascension Orthopedics, Inc. | 2023 | — |
| +2 | K220142 | BRM Digitalis Spacer | Brm Extremities Srl | 2023 | — |
| +2 | K211385 | KeriFlex® MCP and PIP Finger Joint Prostheses | Keri Medical SA | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 2 | 0 |
| 2022 | 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? (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 |
|---|---|---|---|
| * | K970544 | Depuy Dupont Orthopaedics Finger Joint ProsthesisSummary page 1…Prosthesis is substantiated by its similarity in indications for use, design, materials, sterilization and packaging to the current DePuy NeuFlex MCP Finger Prosthesis (K970544) and the Dow Corning Wright Swanson Finger Implant. The determination of substantial equivalence for this device was based on a… | 1997 |
| * | — | Dow Corning Wright Swanson Finger Implant Named without a submission number |
What descends from it? (5)
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)
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 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K001922 · printed Nov 6, 2026
Cite this page
510(k) Report. “K001922: 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/K001922
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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