Universal Total Wrist System
FDA 510(k) K030037 · Kinetikos Medical, Inc.
510(k) numberK030037
Submission
- Device name
- Universal Total Wrist System
- Applicant
- Kinetikos Medical, Inc.
Carlsbad, CA, US - Received
- January 6, 2003
- Decision date
- February 5, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
| K021859 | Wrist ImplantJWJ · Traditional | Avanta Orthopaedics, Inc. | 12/02/2002SE |
More from Avanta Orthopaedics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K061749 | Eclipse Total Ankle ImplantHSN · Traditional | 11/22/2006SE |
| K061465 | Kmi Cement Restrictor ImplantJDK · Traditional | 10/05/2006SESU |
| K051611 | Mbaresorb ImplantHWC · Traditional | 09/06/2005SE |
| K041461 | Kmi Distal Volar Radius Plate SystemHRS · Traditional | 08/16/2004SE |
| K032806 | Katalyst Radial Head ImplantKWI · Traditional | 04/16/2004SE |
| K040356 | Kompressor Screw SystemHWC · Special | 03/01/2004SE |
| K024233 | Kompressor Screw SystemHWC · Traditional | 02/06/2003SE |
| K023770 | K2 Hemi Toe Implant System (Formerly Zobel Great Toe Implant System)KWD · Special | 12/12/2002SE |
| K020554 | Modification to Universal Total Wrist SystemJWJ · Special | 05/03/2002SE |
| K991873 | Kmi Wrist Fusion SystemHRS · Traditional | 08/17/1999SE |
Questions and answers
When was Universal Total Wrist System cleared by the FDA?
Universal Total Wrist System (K030037) received a 510(k) decision of Substantially Equivalent on February 5, 2003, 30 days after the submission was received.
What is the product code of K030037?
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.