FDA product code KYI: Prosthesis, Wrist, Carpal Trapezium
KYI is the FDA product code for prosthesis, wrist, carpal trapezium. It is a Class II device, regulated under 21 CFR 888.3770 and reviewed by the Orthopedic panel. FDA has cleared 26 510(k) submissions under KYI, from 15 different applicants. The average 510(k) review took 139 days (median 88). FDA has posted 5 recalls for KYI devices.
Classification
| Field | Value |
|---|---|
| Device name | Prosthesis, Wrist, Carpal Trapezium |
| Device class | Class II |
| Regulation | 21 CFR 888.3770 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for KYI
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 20 |
| 2020 | 1 | 224 |
Compare with all 510(k) review times · Search every KYI clearance
Top KYI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Wrightmedicaltechnologyinc | 4 | 2003-12-03 |
| Artimplant AB | 3 | 2007-06-07 |
| Ascension Orthopedics, Inc. | 3 | 2006-08-11 |
| Skeletal Dynamics, LLC | 2 | 2018-04-11 |
| Biopro, Inc. | 2 | 2006-06-20 |
10 more applicants have KYI clearances. See the full list in Caduvo.
Most recent KYI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K201072 | Ensemble Orthopedics, LLC | Ensemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 161 | 2020-12-02 | 224 |
| K180744 | Skeletal Dynamics, LLC | Stablyx CMC Arthroplasty Implant System | 2018-04-11 | 20 |
| K111068 | Skeletal Dynamics, LLC | STABLYX CMC ARTHROPLASTY IMPLANT MODEL SIZES 1, 2, 3, 4, AND 5 | 2011-12-30 | 256 |
| K112278 | Ascension Orthopedic | ASCENSION NUGRIP CMC IMPLANT | 2011-11-04 | 87 |
| K092548 | Extremity Medical, LLC | EXTREMITY MEDICAL TRAPEZIUM PROSTHESIS | 2009-12-15 | 118 |
Recalls for KYI devices
5 product recalls in 4 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2016-11-08.
Frequently asked questions
What is FDA product code KYI?
KYI is the FDA product code for prosthesis, wrist, carpal trapezium. It is a Class II device, regulated under 21 CFR 888.3770 and reviewed by the Orthopedic panel.
What device class is KYI?
Class II, regulation 21 CFR 888.3770. Typical premarket route: 510(k).
How long does a 510(k) take for product code KYI?
Across 26 cleared submissions the average was 139 days from receipt to decision (median 88).
Which companies have the most KYI clearances?
Wrightmedicaltechnologyinc (4); Artimplant AB (3); Ascension Orthopedics, Inc. (3); Skeletal Dynamics, LLC (2); Biopro, Inc. (2).
Have KYI devices been recalled?
Yes: 5 product recalls across 4 recall events; the most recent began 2016-11-08.
Next steps
- Run an FDA pathway report with predicate devices for product code KYI
- Run a recall and safety report across every KYI manufacturer
- Watch product code KYI for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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