510(k) · Cleared
ClearedKeriFlex® MCP and PIP Finger Joint Prostheses
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Keri Medical SA · KYJ Prosthesis, Finger, Constrained, Polymer
Cleared on Jul 27, 2022 as substantially equivalent to K083107 (DePuy Orthopaedics, Inc., 2009) and 1 other predicate after a 449-day review. Its family tree reaches back 3 generations to 1997.
- Decided
- Jul 27, 2022
- Review
- 449 days
- Class
- Class II
- Product code
- KYJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K970544 (1997). 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 backK083107 Modification to Depuy Neuflex Pip FingerDePuy Orthopaedics, Inc. · 2009
- This deviceK211385 KeriFlex® MCP and PIP Finger Joint ProsthesesKeri Medical SA · 2022
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 | K083107 | Modification to Depuy Neuflex Pip Finger | DePuy Orthopaedics, Inc. | 2009 | — |
| 0 (this device) | K211385 | KeriFlex® MCP and PIP Finger Joint Prostheses | Keri Medical SA | 2022 | — |
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
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 |
|---|---|---|---|
| * | K083107 | Modification to Depuy Neuflex Pip FingerSummary page 4…8.3230 Class: II Product Code: KYJ Predicate Devices: DePuy Orthopaedics’ NeuFlex PIP Finger Joint Prosthesis (K083107) DePuy Orthopaedics’ MCP Finger Joint Prosthesis (K970544) Indications for Use: The KeriFlex® M… | 2009 |
| * | K970544 | Depuy Dupont Orthopaedics Finger Joint ProsthesisSummary page 4…Devices: DePuy Orthopaedics’ NeuFlex PIP Finger Joint Prosthesis (K083107) DePuy Orthopaedics’ MCP Finger Joint Prosthesis (K970544) Indications for Use: The KeriFlex® MCP and KeriFlex® PIP Finger Joint Prostheses are indicated for cementless replacement of t… | 1997 |
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 25 years and passes through 3 companies; a new generation was cleared every 8.4 years on median.
- None of the 3 ancestors has a recall.
How does its category compare?
All KYJ devicesKYJ Prosthesis, Finger, Constrained, Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 KeriFlex® MCP and KeriFlex® PIP Finger Joint Prostheses are indicated for cementless replacement of the metacarpophalangeal (MCP) and interphalangeal (PIP) joints, respectively, where disabled by rheumatoid, degenerative or traumatic arthritis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K211385 · printed Nov 3, 2026
Cite this page
510(k) Report. “K211385: KeriFlex® MCP and PIP Finger Joint Prostheses.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K211385
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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