METAL HEMI IMPLANT
FDA 510(k) clearance K071243 · decided 2007-05-23
Clearance details
- K-number
- K071243
- Device name
- METAL HEMI IMPLANT
- Applicant
- Orthopro, LLC
- Decision
- Substantially Equivalent
- Date received
- 2007-05-03
- Decision date
- 2007-05-23
- Days to decision
- 20 days
- Clearance type
- Special
- Product code
- KWD
- Device class
- 2
- Regulation number
- 888.3730
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Round Rock, TX, US
- Third-party review
- No
- Expedited review
- No
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Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| HYALEX® MTP Hemiarthroplasty Implant (K250074) | Hyalex Orthopaedics, Inc. | 2026-04-03 |
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| Montross Extremity Medical Hemi Implant System (K221220) | Montross Extremity Medical | 2023-04-19 |
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| restor3d MTP Implant (K201393) | Restor3D, Inc. | 2022-05-25 |
| BioPoly Great Toe Hemiarthroplasty Implant (K203634) | BioPoly, LLC | 2021-02-02 |
| Accu-Joint Hemi Implant (K200951) | Accufix Surgical, Inc. | 2020-12-08 |
| BOSS Toe Fixation System (K190261) | Arthrosurface, Inc. | 2019-08-14 |
| Cannulated Hemi Implant (K190543) | Vilex IN Tennessee, Inc. | 2019-05-31 |
| Life Spine Metatarsal Hemi Implant (K161279) | Life Spine, Inc. | 2017-02-01 |
| HemiCAP MTP Resurfacing Hemi-Arthroplasty System (K152454) | Arthrosurface, Inc. | 2016-04-11 |
| HEMICAP MTP RESURFACING HEMI-ARTHROPLASTY IMPLANT (K131377) | Arthrosurface, Inc. | 2013-11-19 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Metal Hemiarthroplasty, MDL E536687, Part # 03-6000-1, 03-6000-02, 03-600-03, 03-6000-04, recall (Z-2228-2008) | OrthoPro LLC | 2008-09-18 |