Interphalangeal Joint Fusion Device Range
FDA 510(k) K191424 · Neosteo
510(k) numberK191424
Submission
- Device name
- Interphalangeal Joint Fusion Device Range
- Applicant
- Neosteo
Nantes, FR - Received
- May 29, 2019
- Decision date
- August 28, 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 |
|---|---|---|
| K212545 | FlexitSystem Knee osteotomy systemHRS · Traditional | 02/11/2022SE |
| K192447 | Superelastic StapleJDR · Traditional | 02/28/2020SE |
| K153182 | Self- Compressive ScrewHWC · Traditional | 11/25/2015SE |
| K150772 | Snap-Off Self-Compressive ScrewHWC · Traditional | 05/08/2015SE |
| K131471 | Self-Compressive ScrewHWC · Traditional | 08/28/2013SE |
Questions and answers
When was Interphalangeal Joint Fusion Device Range cleared by the FDA?
Interphalangeal Joint Fusion Device Range (K191424) received a 510(k) decision of Substantially Equivalent on August 28, 2019, 91 days after the submission was received.
What is the product code of K191424?
The FDA product code is HWC – Screw, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3040.