Cannulated Metallic Hemi Toe Implant, Models MPJ241975, MPJ221775, MPJ211675, MPJ191565, MPJ171365
FDA 510(k) K023684 · Vilex, Inc.
510(k) numberK023684
Submission
- Device name
- Cannulated Metallic Hemi Toe Implant, Models MPJ241975, MPJ221775, MPJ211675, MPJ191565, MPJ171365
- Applicant
- Vilex, Inc.
Pleasant Hills, PA, US - Received
- November 1, 2002
- Decision date
- March 1, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- KWD – Prosthesis, Toe, Hemi-, Phalangeal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3730
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code KWD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K250074 | HYALEX® MTP Hemiarthroplasty ImplantKWD · Traditional | Hyalex Orthopaedics, Inc. | 04/03/2026SE |
| K240268 | Accu-Joint Hemi ImplantKWD · Special | Accufix Surgical, Inc. | 02/29/2024SE |
| K221220 | Montross Extremity Medical Hemi Implant SystemKWD · Traditional | Montross Extremity Medical | 04/19/2023SE |
| K222964 | BioPoly Lesser Toe Hemiarthroplasty ImplantKWD · Traditional | BioPoly, LLC | 11/22/2022SE |
| K201393 | restor3d MTP ImplantKWD · Traditional | Restor3D, Inc. | 05/25/2022SE |
| K203634 | BioPoly Great Toe Hemiarthroplasty ImplantKWD · Traditional | BioPoly, LLC | 02/02/2021SE |
| K200951 | Accu-Joint Hemi ImplantKWD · Traditional | Accufix Surgical, Inc. | 12/08/2020SE |
| K190261 | BOSS Toe Fixation SystemKWD · Traditional | Arthrosurface, Inc. | 08/14/2019SE |
| K190543 | Cannulated Hemi ImplantKWD · Traditional | Vilex IN Tennessee, Inc. | 05/31/2019SE |
| K161279 | Life Spine Metatarsal Hemi ImplantKWD · Traditional | Life Spine, Inc. | 02/01/2017SE |
More from Life Spine, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K260900 | DYNEX® External Fixation SystemsKTT · Special | 04/17/2026SE |
| K250304 | TITANEX Screw SystemsHWC · Special | 03/05/2025SE |
| K240475 | Hintermann Series H2 Total Ankle SystemHSN · Traditional | 12/02/2024SE |
| K243408 | TACTIX Vector Syndesmosis SystemHTN · Special | 11/27/2024SE |
| K233816 | REDEMPTION Charcot Plating SystemHRS · Traditional | 08/28/2024SE |
| K240035 | TACTIX Vector Syndesmosis SystemHTN · Traditional | 08/01/2024SE |
| K231343 | Redemption Duo Hindfoot Nail SystemHSB · Traditional | 01/30/2024SE |
| K231504 | TITANEX MICROBEAM Screw System, TITANEX ARTEMIS Screw SystemHWC · Traditional | 09/11/2023SE |
| K231493 | NITINEX Memory Compression StapleJDR · Traditional | 08/11/2023SE |
| K230462 | OPTIX H2 Patient Specific Instrument SystemHSN · Traditional | 07/17/2023SE |
Questions and answers
When was Cannulated Metallic Hemi Toe Implant, Models MPJ241975, MPJ221775, MPJ211675, MPJ191565, MPJ171365 cleared by the FDA?
Cannulated Metallic Hemi Toe Implant, Models MPJ241975, MPJ221775, MPJ211675, MPJ191565, MPJ171365 (K023684) received a 510(k) decision of Substantially Equivalent on March 1, 2004, 486 days after the submission was received.
What is the product code of K023684?
The FDA product code is KWD – Prosthesis, Toe, Hemi-, Phalangeal, a Class II (moderate risk) device regulated under 21 CFR 888.3730.