Prosthesis, Wrist, Hemi-, Ulnar
The Ulnar Hemi Wrist Prosthesis is an orthopedic implant used to replace the distal ulnar component of the wrist joint, typically indicated following resection of the distal ulna due to arthritis, instability, or prior surgical procedures, to maintain wrist alignment and function. It is classified as FDA Class 2, indicating moderate risk, and requires a 510(k) premarket notification before marketing. The product code is KXE, regulated under 21 CFR 888.3810, in the Orthopedic medical specialty. This device is an implant.
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Basic Information
- Product Code
- KXE
- Device Class
- FDA class 2
- Regulation Number
- 888.3810
- Medical Specialty
- Orthopedic
- Review Panel
- OR
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 16 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K190599 | Aptis Medical Distal Radio Ulnar Joint Implant | May 03, 2019 | Substantially Equivalent | Aptis Medical, LLC |
| K142569 | Aptis Medical Distal Radio Ulnar Joint Implant | Apr 03, 2015 | Substantially Equivalent | Aptis Medical, LLC |
| K112481 | FIRST CHOICE DRUJ SYSTEM, PARTIAL HEAD IMPLANT | Apr 09, 2012 | Substantially Equivalent | Ascension Orthopedic |
| K081025 | ISOELASTICU | Nov 21, 2008 | Substantially Equivalent | Remi Sciences, Inc. |
| K082839 | DISTAL RADIO-ULNAR JOINT IMPLANT | Oct 24, 2008 | Substantially Equivalent | Aptis Medical, LLC |
| K061146 | SBI ULNAR HEAD IMPLANT | Jul 19, 2006 | Substantially Equivalent | Small Bone Innovations, Inc. |
| K053119 | DISTAL RADIO-ULNAR JOINT IMPLANT | Dec 07, 2005 | Substantially Equivalent | Aptis Medical, LLC |
| K052137 | ASCENSION MUH | Nov 03, 2005 | Substantially Equivalent | Ascension Orthopedics, Inc. |
| K040497 | DISTAL RADIO-ULNAR JOINT IMPLANT | Jan 26, 2005 | Substantially Equivalent | Aptis Medical, LLC |
| K042902 | HERBERT ULNAR HEAD PROSTHESIS SYSTEM | Dec 27, 2004 | Substantially Equivalent | Stuckenbrock Medizintechnik GmbH |
| K033930 | KAPP CUSTOM ULNAR HEAD WRIST IMPLANT | Jul 28, 2004 | Substantially Equivalent | Kapp Surgical Instrument, Inc. |
| K020274 | WMT MODULAR ULNAR HEAD IMPLANT | Feb 22, 2002 | Substantially Equivalent | Wrightmedicaltechnologyinc |
| K010786 | ULNAR HEAD IMPLANT | Apr 11, 2001 | Substantially Equivalent | Avanta Orthopaedics, Inc. |
| K982268 | ULNAR HEAD IMPLANT | Dec 04, 1998 | Substantially Equivalent | Avanta Orthopaedics, Inc. |
| K812053 | SILASTIC HEMI WRIST IMPLANT H.P. (RAD.) | Aug 18, 1981 | Substantially Equivalent | Dow Corning Corp. Healthcare Industries Materials |
| K790125 | ULNAR HEAD PROTHESIS | Feb 08, 1979 | Substantially Equivalent | Cutter Laboratories, Inc. |
FEI Numbers
This FDA classification entry is associated with 18 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 18 registration numbers. Click on an entry to view related FDA registrations.