Lesser Metatarsal Head Implant System
FDA 510(k) K131187 · Solana Surgical, LLC
510(k) numberK131187
Submission
- Device name
- Lesser Metatarsal Head Implant System
- Applicant
- Solana Surgical, LLC
Memphis, TN, US - Received
- April 26, 2013
- Decision date
- October 22, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
|---|---|---|
| K132594 | Crosscheck Plating SystemHRS · Traditional | 12/13/2013SE |
| K124045 | Fuseforce Implant SystemJDR · Traditional | 07/10/2013SE |
| K122738 | Gaitway Implant System, Surgical Instrument SetHWC · Traditional | 11/07/2012SE |
| K120390 | Solafix Twist Screw Implant System, Surgical Instrument SetHWC · Traditional | 04/10/2012SE |
| K120029 | Hemi Phalangeal Implant Surgical Instrument SetKWD · Traditional | 02/06/2012SE |
| K113752 | Metatarsal Decompression Implant Surgical Instrument SetKWD · Traditional | 02/06/2012SE |
| K090127 | Metatarsal Decompression Implant, Model 100KWD · Traditional | 05/01/2009SE |
Questions and answers
When was Lesser Metatarsal Head Implant System cleared by the FDA?
Lesser Metatarsal Head Implant System (K131187) received a 510(k) decision of Substantially Equivalent on October 22, 2013, 179 days after the submission was received.
What is the product code of K131187?
The FDA product code is KWD – Prosthesis, Toe, Hemi-, Phalangeal, a Class II (moderate risk) device regulated under 21 CFR 888.3730.