HemiCAP MTP Resurfacing Hemi-Arthroplasty System
FDA 510(k) K152454 · Arthrosurface, Inc.
510(k) numberK152454
Submission
- Device name
- HemiCAP MTP Resurfacing Hemi-Arthroplasty System
- Applicant
- Arthrosurface, Inc.
Franklin, MA, US - Received
- August 28, 2015
- Decision date
- April 11, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
|---|---|---|
| K203375 | OVOMotion Reverse Shoulder Arthroplasty SystemPHX · Traditional | 06/24/2021SE |
| K200718 | Arthrosurface WristMotion Total Wrist Arthroplasty SystemJWJ · Traditional | 10/15/2020SE |
| K190261 | BOSS Toe Fixation SystemKWD · Traditional | 08/14/2019SE |
| K181280 | Patello-Femoral Wave (Kahuna) Arthroplasty SystemKRR · Special | 06/14/2018SE |
| K173964 | OVOMotion Shoulder Arthroplasty SystemHSD · Traditional | 04/18/2018SE |
| K172383 | Arthrosurface Bone ScrewsHWC · Traditional | 12/22/2017SE |
| K170440 | KISSloc Suture SystemHTN · Traditional | 05/03/2017SE |
| K170350 | ToeMATE® Hammertoe Correction SystemHWC · Special | 03/03/2017SE |
| K162391 | AlignMATE Lapidus Arthrodesis SystemHRS · Special | 02/21/2017SE |
| K161539 | Arthrosurface Bone ScrewsHWC · Special | 06/30/2016SE |
Questions and answers
When was HemiCAP MTP Resurfacing Hemi-Arthroplasty System cleared by the FDA?
HemiCAP MTP Resurfacing Hemi-Arthroplasty System (K152454) received a 510(k) decision of Substantially Equivalent on April 11, 2016, 227 days after the submission was received.
What is the product code of K152454?
The FDA product code is KWD – Prosthesis, Toe, Hemi-, Phalangeal, a Class II (moderate risk) device regulated under 21 CFR 888.3730.