Product code KWN
- Device name
- Prosthesis, Wrist, Carpal Lunate
- Medical specialty
- Orthopedic
- Device class
- 2
- Regulation number
- 888.3750
- Review panel
- OR
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K141920 | Wrist Hemiarthroplasty System | Arthrosurface, Inc. | 2014-12-23 |
| K080997 | ASCENSION PYROCARBON LUNATE | Ascension Orthopedics, Inc. | 2008-06-17 |
| K050028 | MAESTRO CARPAL HEMIARTHROPLASTY | Biomet Manufacturing, Inc. | 2005-03-25 |
| K864491 | SWANSON TITANIUM CARPAL LUNATE IMPLANT | Dow Corning Wright | 1987-04-15 |
| K790793 | AMC R METACARPAL COMPONENT | Howmedica Corp. | 1979-06-22 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00885556858745 | PyroCarbon Lunate | Smith & Nephew, Inc. | 2023-02-10 |
| 00885556858738 | PyroCarbon Lunate | Smith & Nephew, Inc. | 2023-02-10 |
| 00885556858721 | PyroCarbon Lunate | Smith & Nephew, Inc. | 2023-02-10 |
| M5288W122217A0 | HemiCAPITATETM | ARTHROSURFACE INCORPORATED | 2018-04-16 |
| 00887868239847 | Maestro™ Total Wrist | Biomet Orthopedics, LLC | 2018-03-02 |
| 00887868239830 | Maestro™ Total Wrist | Biomet Orthopedics, LLC | 2018-03-02 |
| 10381780116288 | Ascension® PyroCarbon Lunate | Ascension Orthopedics, Inc. | 2017-10-09 |
| 10381780116271 | Ascension® PyroCarbon Lunate | Ascension Orthopedics, Inc. | 2017-10-09 |
| 10381780116264 | Ascension® PyroCarbon Lunate | Ascension Orthopedics, Inc. | 2017-10-09 |
| 10381780116257 | Ascension® PyroCarbon Lunate | Ascension Orthopedics, Inc. | 2017-10-09 |
| 10381780116240 | Ascension® PyroCarbon Lunate | Ascension Orthopedics, Inc. | 2017-10-09 |
| M269TRL71502T1 | Integra® | Ascension Orthopedics, Inc. | 2016-08-15 |
| 10381780236795 | Integra® | Ascension Orthopedics, Inc. | 2016-08-15 |
| 10381780236801 | Integra® | Ascension Orthopedics, Inc. | 2016-08-15 |
| 10381780236818 | Integra® | Ascension Orthopedics, Inc. | 2016-08-15 |
| M269TRL71505T1 | Integra® | Ascension Orthopedics, Inc. | 2016-08-15 |
| M269TRL71504T1 | Integra® | Ascension Orthopedics, Inc. | 2016-08-15 |
| M269TRL71503T1 | Integra® | Ascension Orthopedics, Inc. | 2016-08-15 |
| 10381780236832 | Integra® | Ascension Orthopedics, Inc. | 2016-08-15 |
| M269TRL71501T1 | Integra® | Ascension Orthopedics, Inc. | 2016-08-15 |
| M268PYROLUNINSTP1 | Integra® | Ascension Orthopedics, Inc. | 2016-08-15 |
| 10381780235040 | Integra® | Ascension Orthopedics, Inc. | 2016-08-15 |
| 10381780236825 | Integra® | Ascension Orthopedics, Inc. | 2016-08-15 |
| M5288W950016A0 | HemiCAPITATETM | ARTHROSURFACE INCORPORATED | 2016-07-14 |
| M5288W153523A0 | HemiCAPITATETM | ARTHROSURFACE INCORPORATED | 2016-07-14 |
| M5288W153517A0 | HemiCAPITATETM | ARTHROSURFACE INCORPORATED | 2016-07-14 |
| M5288W152223A0 | HemiCAPITATETM | ARTHROSURFACE INCORPORATED | 2016-07-14 |
| M5288W152217A0 | HemiCAPITATETM | ARTHROSURFACE INCORPORATED | 2016-07-14 |
| M5288W123517A0 | HemiCAPITATETM | ARTHROSURFACE INCORPORATED | 2016-07-14 |
| 00880304481107 | MAESTRO TOTAL WRIST | Biomet Orthopedics, LLC | 2015-10-24 |