Aptis Medical Distal Radio Ulnar Joint Implant
FDA 510(k) K190599 · Aptis Medical, LLC
510(k) numberK190599
Submission
- Device name
- Aptis Medical Distal Radio Ulnar Joint Implant
- Applicant
- Aptis Medical, LLC
Glenview, KY, US - Received
- March 8, 2019
- Decision date
- May 3, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KXE – Prosthesis, Wrist, Hemi-, Ulnar
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3810
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code KXE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K142569 | Aptis Medical Distal Radio Ulnar Joint ImplantKXE · Traditional | Aptis Medical, LLC | 04/03/2015SE |
| K112481 | First Choice Druj System, Partial Head ImplantKXE · Traditional | Ascension Orthopedic | 04/09/2012SE |
| K081025 | IsoelasticuKXE · Traditional | Remi Sciences, Inc. | 11/21/2008SE |
| K082839 | Distal Radio-Ulnar Joint ImplantKXE · Special | Aptis Medical, LLC | 10/24/2008SE |
| K061146 | Sbi Ulnar Head ImplantKXE · Special | Small Bone Innovations, Inc. | 07/19/2006SE |
| K053119 | Distal Radio-Ulnar Joint ImplantKXE · Special | Aptis Medical, LLC | 12/07/2005SE |
| K052137 | Ascension MuhKXE · Traditional | Ascension Orthopedics, Inc. | 11/03/2005SE |
| K040497 | Distal Radio-Ulnar Joint ImplantKXE · Traditional | Aptis Medical, LLC | 01/26/2005SE |
| K042902 | Herbert Ulnar Head Prosthesis SystemKXE · Traditional | Stuckenbrock Medizintechnik GmbH | 12/27/2004SE |
| K033930 | Kapp Custom Ulnar Head Wrist ImplantKXE · Traditional | Kapp Surgical Instrument, Inc. | 07/28/2004SE |
More from Kapp Surgical Instrument, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K142569 | Aptis Medical Distal Radio Ulnar Joint ImplantKXE · Traditional | 04/03/2015SE |
| K082839 | Distal Radio-Ulnar Joint ImplantKXE · Special | 10/24/2008SE |
| K053119 | Distal Radio-Ulnar Joint ImplantKXE · Special | 12/07/2005SE |
| K040497 | Distal Radio-Ulnar Joint ImplantKXE · Traditional | 01/26/2005SE |
Questions and answers
When was Aptis Medical Distal Radio Ulnar Joint Implant cleared by the FDA?
Aptis Medical Distal Radio Ulnar Joint Implant (K190599) received a 510(k) decision of Substantially Equivalent on May 3, 2019, 56 days after the submission was received.
What is the product code of K190599?
The FDA product code is KXE – Prosthesis, Wrist, Hemi-, Ulnar, a Class II (moderate risk) device regulated under 21 CFR 888.3810.