Extremity Medical Trapezium Prosthesis
FDA 510(k) K092548 · Extremity Medical, LLC
510(k) numberK092548
Submission
- Device name
- Extremity Medical Trapezium Prosthesis
- Applicant
- Extremity Medical, LLC
Parsippany, NJ, US - Received
- August 19, 2009
- Decision date
- December 15, 2009
- 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
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| K201072 | Ensemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 161KYI · Traditional | Ensemble Orthopedics, LLC | 12/02/2020SE |
| 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 |
| 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 |
More from Biopro, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K250536 | MetaFore Small Screw SystemHWC · Traditional | 10/08/2025SE |
| K251128 | Extremity Medical External Fixation SystemKTT · Special | 05/07/2025SE |
| K241563 | Extremity Medical External Fixation SystemKTT · Traditional | 02/21/2025SE |
| K212297 | Omni Foot and Ankle Plating SystemHRS · Special | 08/20/2021SE |
| K211261 | Axis Charcot Fixation SystemHWC · Special | 05/28/2021SE |
| K201556 | Intraosseous Fixation SystemHWC · Special | 07/08/2020SE |
| K191525 | KinematX Total Wrist Arthroplasty SystemJWJ · Traditional | 03/04/2020SE |
| K192592 | Axis Plating SystemHRS · Traditional | 11/21/2019SE |
| K181067 | AlignX Ankle Fusion SystemHRS · Special | 05/23/2018SE |
| K180808 | Omni Foot Plating SystemHRS · Traditional | 05/22/2018SE |
Questions and answers
When was Extremity Medical Trapezium Prosthesis cleared by the FDA?
Extremity Medical Trapezium Prosthesis (K092548) received a 510(k) decision of Substantially Equivalent on December 15, 2009, 118 days after the submission was received.
What is the product code of K092548?
The FDA product code is KYI – Prosthesis, Wrist, Carpal Trapezium, a Class II (moderate risk) device regulated under 21 CFR 888.3770.