Ensemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 161
FDA 510(k) K201072 · Ensemble Orthopedics, LLC
510(k) numberK201072
Submission
- Device name
- Ensemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 161
- Applicant
- Ensemble Orthopedics, LLC
Austin, TX, US - Received
- April 22, 2020
- Decision date
- December 2, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KYI – Prosthesis, Wrist, Carpal Trapezium
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3770
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code KYI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K180744 | Stablyx CMC Arthroplasty Implant SystemKYI · Special | Skeletal Dynamics, LLC | 04/11/2018SE |
| K111068 | Stablyx CMC Arthroplasty Implant Model Sizes 1, 2, 3, 4, and 5KYI · Traditional | Skeletal Dynamics, LLC | 12/30/2011SE |
| K112278 | Ascension Nugrip CMC ImplantKYI · Traditional | Ascension Orthopedic | 11/04/2011SE |
| K092548 | Extremity Medical Trapezium ProsthesisKYI · Traditional | Extremity Medical, LLC | 12/15/2009SE |
| K061956 | Artelon STT SpacerKYI · Traditional | Artimplant AB | 06/07/2007SE |
| K061954 | Artelon CMC Spacer ArthroKYI · Special | Artimplant AB | 06/01/2007SE |
| K061451 | Ascension, Models CMC-400,13,CMC-400-20,CMC-400-30,CMC-400-40KYI · Traditional | Ascension Orthopedics, Inc. | 08/11/2006SE |
| K061089 | Modular Thumb Implant, Models 17600, 17601, 17602, 17603, 17596, 17597, 17598, 17599KYI · Traditional | Biopro, Inc. | 06/20/2006SE |
| K060386 | Nexa Carpo Metacarpal ImplantKYI · Traditional | Nexa Orthopedics, Inc. | 05/10/2006SE |
| K052596 | Modular Thumb Implant, Models 17065,17066,17243,17067,17199,17238,17005,17239,17006,17240…KYI · Traditional | Biopro, Inc. | 11/15/2005SE |
Questions and answers
When was Ensemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 161 cleared by the FDA?
Ensemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 161 (K201072) received a 510(k) decision of Substantially Equivalent on December 2, 2020, 224 days after the submission was received.
What is the product code of K201072?
The FDA product code is KYI – Prosthesis, Wrist, Carpal Trapezium, a Class II (moderate risk) device regulated under 21 CFR 888.3770.