510(k) · Cleared
ClearedNexa Carpo Metacarpal Implant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nexa Orthopedics, Inc. · KYI Prosthesis, Wrist, Carpal Trapezium
Cleared on May 10, 2006 after an 85-day review. The FDA summary names no predicate by number.
- Decided
- May 10, 2006
- Review
- 85 days
- Class
- Class II
- Product code
- KYI
- Recalls
- None
- Predicates
- 0
The FDA summary names no predicate by number.
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 KYI? 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 KYI device
- #1 K201072 Ensemble CMC, Size 141, Ensemble CMC, Size…score 2.0 · 6 generations · no Class I recall
What was it cleared against?
The FDA summary names no predicate by 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All KYI devicesKYI Prosthesis, Wrist, Carpal Trapezium: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KYI
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · KYI
Too few KYI 510(k)s in any year since 2007 to give a median.
Recalls per year · KYI
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KYI
1in 2024
MAUDE reports naming product code KYI, 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 | 2 | — | 0 | 32 |
| 2008 | 0 | — | 0 | 51 |
| 2009 | 1 | — | 0 | 56 |
| 2010 | 0 | — | 2 | 25 |
| 2011 | 2 | — | 0 | 72 |
| 2012 | 0 | — | 0 | 22 |
| 2013 | 0 | — | 0 | 23 |
| 2014 | 0 | — | 0 | 4 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 1 | 3 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 4 |
| 2019 | 0 | — | 0 | 14 |
| 2020 | 1 | — | 0 | 8 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The device is intended to replace the proximal end of the first metacarpal in cases of
rheumatoid arthritis, traumatic arthritis, osteoarthritis or post fracture deformation or
bone loss which present as either a painful, unstable thumb, or a thumb with limited
range of motion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060386 · printed Nov 4, 2026
Cite this page
510(k) Report. “K060386: Nexa Carpo Metacarpal Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060386
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026