510(k) · Cleared
Recalled · Class II · 2025Osteotec Silicone Finger Implant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Osteotec, Ltd. · KYJ Prosthesis, Finger, Constrained, Polymer
Cleared on Apr 17, 2015 as substantially equivalent to K013629 (Avanta Orthopaedics, Inc., 2002) after a 417-day review. Its family tree reaches back 2 generations to 1987. It has been recalled once.
- Decided
- Apr 17, 2015
- Review
- 417 days
- Class
- Class II
- Product code
- KYJ
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K870200 (1987). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 |
|---|---|---|---|
| * | K013629 | Finger Joint ProsthesisSummary page 5…been legally marketed in the U.S. since 2002 by: Small Bone Innovations, Inc. 1380 South Pennsylvania Ave. Morrisville, PA 19067 510(k) No. K013629 FDA Decision Date – 25 January 2002 FDA Device Class - 2 FDA Classification Name – Finger joint polymer constra… | 2002 |
| * | — | Swanson Flexible Finger Joint Implant Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 18, 2025 | Class II | Z-2222-2025 | Process change control | There is the potential that the silicone implant may contain foreign material |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 28 years and passes through 3 companies; a new generation was cleared every 14.3 years on median.
- None of the 2 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. 2015, 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 OSTEOTEC Silicone Finger Implant is a single piece flexible joint replacement implant for the metacarpophalangeal (MCP) joint and proximal interphalangeal (PIP) joints in the hand; commonly due to rheumatoid arthritis or osteoarthritis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140453 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140453: Osteotec Silicone Finger Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140453
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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