InCore TMT System
FDA 510(k) K192578 · Nextremity Solutions, Inc.
510(k) numberK192578
Submission
- Device name
- InCore TMT System
- Applicant
- Nextremity Solutions, Inc.
Warsaw, IN, US - Received
- September 19, 2019
- Decision date
- December 31, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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
Other 510(k)s with product code HWC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
|---|---|---|
| K221610 | Nextra CH Cannulated Hammertoe SystemHWC · Traditional | 11/04/2022SE |
| K212979 | CalcShift Displacement Calcaneal Osteotomy SystemHRS · Traditional | 05/20/2022SE |
| K220181 | StealthFix Intraosseous Fixation SystemJDR · Traditional | 03/22/2022SE |
| K213301 | InCore Subtalar SystemHWC · Traditional | 12/21/2021SE |
| K213530 | Nextra CH Cannulated Hammertoe SystemHWC · Special | 12/09/2021SE |
| K212640 | Stratum® Ankle Fusion Plating SystemHRS · Traditional | 11/18/2021SE |
| K211996 | Nexta PEEK Hammertoe Correction SystemHWC · Traditional | 09/23/2021SE |
| K200785 | Stratum Reduced Size Foot Plating SystemHRS · Traditional | 07/27/2020SE |
| K200840 | DuoHex CH Cannulated Hammertoe SystemHWC · Traditional | 06/26/2020SE |
| K200124 | InCore MPJ SystemHWC · Traditional | 05/13/2020SE |
Questions and answers
When was InCore TMT System cleared by the FDA?
InCore TMT System (K192578) received a 510(k) decision of Substantially Equivalent on December 31, 2019, 103 days after the submission was received.
What is the product code of K192578?
The FDA product code is HWC – Screw, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3040.