Wrist Implant
FDA 510(k) K021859 · Avanta Orthopaedics, Inc.
510(k) numberK021859
Submission
- Device name
- Wrist Implant
- Applicant
- Avanta Orthopaedics, Inc.
San Diego, CA, US - Received
- June 6, 2002
- Decision date
- December 2, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JWJ – Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3800
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code JWJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K243381 | Total Wrist Arthroplasty System (TWA)JWJ · Special | Skeletal Dynamics, Inc. | 11/01/2024SE |
| K233574 | Total Wrist Arthroplasty System (TWA)JWJ · Traditional | Skeletal Dynamics | 07/03/2024SE |
| K233674 | Freedom Wrist Arthroplasty SystemJWJ · Traditional | Ascension Orthopedics, Inc. | 05/30/2024SE |
| K200718 | Arthrosurface WristMotion Total Wrist Arthroplasty SystemJWJ · Traditional | Arthrosurface, Inc. | 10/15/2020SE |
| K191525 | KinematX Total Wrist Arthroplasty SystemJWJ · Traditional | Extremity Medical, LLC | 03/04/2020SE |
| K132250 | Integra Freedom Wrist Arthroplasty SystemJWJ · Traditional | Integra LifeSciences Corporation | 03/24/2014SE |
| K080426 | Maestro Wrist Fracture ImplantJWJ · Traditional | Biomet Manufacturing Corp | 07/29/2008SE |
| K042032 | Maestro Total WristJWJ · Traditional | Biomet, Inc. | 10/07/2004SE |
| K031203 | Biax A.F. Wrist/Biax Advanced Fixation WristJWJ · Traditional | DePuy Orthopaedics, Inc. | 07/14/2003SE |
| K030037 | Universal Total Wrist SystemJWJ · Special | Kinetikos Medical, Inc. | 02/05/2003SE |
More from Kinetikos Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K030881 | Avanta Carpal Fusion Plating SystemHRS · Traditional | 04/10/2003SE |
| K023604 | Modification to Radial Head ImplantKWI · Special | 11/27/2002SE |
| K013629 | Finger Joint ProsthesisKYJ · Traditional | 01/25/2002SE |
| K011819 | Radial Head ImplantKWI · Special | 06/19/2001SE |
| K010847 | K'FixNDL · Traditional | 06/19/2001SE |
| K003033 | Scaphix, Staple, Fixation, BoneJDR · Traditional | 05/30/2001SE |
| K010786 | Ulnar Head ImplantKXE · Special | 04/11/2001SE |
| K002644 | Radial Head ImplantKWI · Traditional | 11/20/2000SE |
| K990596 | Distal Radius Fracture Fixation Plate SystemHRS · Traditional | 04/29/1999SE |
| K982268 | Ulnar Head ImplantKXE · Traditional | 12/04/1998SE |
Questions and answers
When was Wrist Implant cleared by the FDA?
Wrist Implant (K021859) received a 510(k) decision of Substantially Equivalent on December 2, 2002, 179 days after the submission was received.
What is the product code of K021859?
The FDA product code is JWJ – Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained, a Class II (moderate risk) device regulated under 21 CFR 888.3800.