ToeMATE® Hammertoe Correction System
FDA 510(k) K170350 · Arthrosurface, Inc.
510(k) numberK170350
Submission
- Device name
- ToeMATE® Hammertoe Correction System
- Applicant
- Arthrosurface, Inc.
Franklin, MA, US - Received
- February 3, 2017
- Decision date
- March 3, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HWC – Screw, Fixation, Bone
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3040
- Specialty
- Orthopedic
- Implant
- Yes
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|---|---|---|---|
| K261057 | ActivaScrew Cannulated COMHWC · Traditional | Bioretec, Ltd. | 09/04/2026SE |
| K260106 | OsteoCoil GT Active Compression SystemHWC · Traditional | Flower Orthopedics Corporation DBA Conventus… | 08/24/2026SE |
| K262344 | Large Compression ScrewsHWC · Special | TriMed, Inc. | 08/12/2026SE |
| K253858 | GFS - Sterile Screws and Top HatHWC · Special | T.A.G. Medical Products Corporation, Ltd. | 08/05/2026SE |
| K262075 | Lapidus Screw KitHWC · Special | Relja Innovations, LLC | 07/22/2026SE |
| K260809 | Arthrex Sterile VAL and VAL KreuLock Compression Screw SystemHWC · Traditional | Arthrex, Inc. | 06/25/2026SE |
| K253108 | VEOFIX Snap Off ScrewHWC · Traditional | Steps Ortho | 06/05/2026SE |
| K261154 | CoLink® & CoLag® Non-Sterile ScrewsHWC · Special | In2Bones USA, LLC | 05/30/2026SE |
| K261241 | TriMed Compression ScrewsHWC · Special | TriMed, Inc. | 05/14/2026SE |
| K254215 | Arthrex Beaming SystemHWC · Traditional | Arthrex, Inc. | 05/08/2026SE |
More from Arthrex, 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 |
| K162391 | AlignMATE Lapidus Arthrodesis SystemHRS · Special | 02/21/2017SE |
| K161539 | Arthrosurface Bone ScrewsHWC · Special | 06/30/2016SE |
| K152454 | HemiCAP MTP Resurfacing Hemi-Arthroplasty SystemKWD · Special | 04/11/2016SE |
Questions and answers
When was ToeMATE® Hammertoe Correction System cleared by the FDA?
ToeMATE® Hammertoe Correction System (K170350) received a 510(k) decision of Substantially Equivalent on March 3, 2017, 28 days after the submission was received.
What is the product code of K170350?
The FDA product code is HWC – Screw, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3040.